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Complementary and Integrative Pain Therapies and Functional Restoration (IMPPPORT) Trial) (IMPPPORT)

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
non-medication, non-interventional therapies
Sponsored by
Madigan Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Significant functional impairment due to pain, requiring modification of military duties.

  • Physically able to participate in up to four hours of physical activity (strength, flexibility, endurance training) per day:

    1. Can stand up from and sit down on floor independently
    2. Can walk on treadmill for at least 6 minutes at 2.5 mile/hour pace or faster.

    3. Able to complete at least 2 of the following:

      1. Lift 20 lbs from floor to knuckle height
      2. Lift 20 lbs from floor to shoulder height
      3. Carry 20lbs at least 40 feet.
  • Inadequate response to previous less intensive treatment
  • Expresses motivation to take active role in regaining function

Exclusion Criteria:

  • Major surgeries within past 6 months or planned within next 6 months
  • Unstable psychological disorders
  • Active substance use disorder
  • High dose opioids of >120 milligrams of morphine equivalent doses (MED)/day

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard rehabilitative care (SC)

    Complementary and Integrative Health (CIH) therapies in addition to Standard rehabilitate care (SC)

    Arm Description

    Twice weekly physical therapy, occupational therapy and pain psychoeducation

    Twice weekly chiropractic, acupuncture, yoga and foam roller instruction, in addition to SC

    Outcomes

    Primary Outcome Measures

    Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - baseline to end of stage 1 treatment
    The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in Impact Score is computed by subtracting baseline Impact Score from the score at the time of reassessment. Improvement is indicated by change scores with negative values.
    Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - baseline to end of stage 2 treatment
    The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in RTF Impact Score from baseline to end of stage 2

    Secondary Outcome Measures

    Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - short-term follow-up
    The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in RTF Impact Score from baseline to short-term post-treatment follow-up.
    Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - intermediate-term follow-up
    The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in RTF Impact Score from baseline to intermediate-term post-treatment follow-up.
    Battery of functional performance measures - Change in walking tolerance from baseline to end of stage 1
    Walking tolerance on a treadmill using the modified Naughton treadmill protocol. Measured in minutes completed. Higher number of minutes indicates better status. Test terminates when pain intensity increases from level at start of treadmill testing. Change score is computed by subtracting the baseline number of minutes completed from the number of minutes completed at the time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in walking tolerance from baseline to end of stage 2
    Walking tolerance on a treadmill using the modified Naughton treadmill protocol. Measured in minutes completed. Higher number of minutes indicates better status. Test terminates when pain intensity increases from level at start of treadmill testing. Change score is computed by subtracting the baseline number of minutes completed from the number of minutes completed at the time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in walking tolerance from baseline to short-term post-treatment follow-up.
    Walking tolerance on a treadmill using the modified Naughton treadmill protocol. Measured in minutes completed. Higher number of minutes indicates better status. Test terminates when pain intensity increases from level at start of treadmill testing. Change score is computed by subtracting the baseline number of minutes completed from the number of minutes completed at the time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in walking tolerance from baseline to intermediate-term post-treatment follow-up
    Walking tolerance on a treadmill using the modified Naughton treadmill protocol. Measured in minutes completed. Higher number of minutes indicates better status. Test terminates when pain intensity increases from level at start of treadmill testing. Change score is computed by subtracting the baseline number of minutes completed from the number of minutes completed at the time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of Stage 1. Improvement is indicated by change scores with positive values.
    Measures how much weight in pounds study subject can comfortably lift from floor to waist height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of Stage 2
    Measures how much weight in pounds study subject can comfortably lift from floor to waist height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of short-term post-treatment follow-up
    Measures how much weight in pounds study subject can comfortably lift from floor to waist height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of intermediate-term post-treatment follow-up
    Measures how much weight in pounds study subject can comfortably lift from floor to waist height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to end of stage-1.
    Measures how much weight in pounds study subject can comfortably lift from waist to shoulder height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to end of stage-2.
    Measures how much weight in pounds study subject can comfortably lift from waist to shoulder height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to short-term post-treatment follow-up.
    Measures how much weight in pounds study subject can comfortably lift from waist to shoulder height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to intermediate-term post-treatment follow-up.
    Measures how much weight in pounds study subject can comfortably lift from waist to shoulder height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to end of stage 1
    Measures how much weight in pounds study subject can carry a distance of 40-feet. Higher number of lbs carried indicates better status. Test terminates when pain intensity increases from start of carry test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds carried from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to end of stage 2.
    Measures how much weight in pounds study subject can carry a distance of 40-feet. Higher number of lbs carried indicates better status. Test terminates when pain intensity increases from start of carry test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds carried from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to short-term post-treatment follow-up.
    Measures how much weight in pounds study subject can carry a distance of 40-feet. Higher number of lbs carried indicates better status. Test terminates when pain intensity increases from start of carry test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds carried from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to intermediate-term post-treatment follow-up.
    Measures how much weight in pounds study subject can carry a distance of 40-feet. Higher number of lbs carried indicates better status. Test terminates when pain intensity increases from start of carry test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds carried from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to end of stage 1
    PROMIS Depression reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse depression. Change score is computed by subtracting baseline Depression T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to end of stage 2
    PROMIS Depression reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse depression. Change score is computed by subtracting baseline Depression T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to short-term post-treatment follow-up
    PROMIS Depression reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse depression. Change score is computed by subtracting baseline Depression T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to intermediate-term post-treatment follow-up
    PROMIS Depression reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse depression. Change score is computed by subtracting baseline Depression T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to end of stage 1.
    PROMIS Anxiety reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anxiety T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to end of stage 2.
    PROMIS Anxiety reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anxiety T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to short-term post-treatment follow-up
    PROMIS Anxiety reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anxiety T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to intermediate-term post-treatment follow-up
    PROMIS Anxiety reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anxiety T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to end of stage 1
    PROMIS Anger reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anger T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
    PROMIS Anger reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anger T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
    PROMIS Anger reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anger T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
    PROMIS Anger reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anger T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to end of stage 1
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse Sleep-related Impairment. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to end of stage 2
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse Sleep-related Impairment. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to short-term post-treatment follow-up
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse Sleep-related Impairment. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to intermediate-term post-treatment follow-up
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse Sleep-related Impairment. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to end of stage 1.
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better physical function. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to end of stage 2.
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better physical function. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to short-term post-treatment follow-up
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better physical function. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to intermediate-term post-treatment follow-up
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better physical function. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to end of stage 1.
    PROMIS Satisfaction with Social Roles reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better satisfaction with social roles. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to end of stage 2
    PROMIS Satisfaction with Social Roles reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better satisfaction with social roles. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to short-term post-treatment follow-up
    PROMIS Satisfaction with Social Roles reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better satisfaction with social roles. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to intermediate-term post-treatment follow-up
    PROMIS Satisfaction with Social Roles reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better satisfaction with social roles. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Pain Catastrophizing Score (PCS), baseline to end of stage 1
    PCS is a 13-item questionnaire with a score range 0-52 with higher scores indicating worse status. Change score is computed by subtracting baseline PCS from PCS at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in Pain Catastrophizing Score (PCS), baseline to end of stage 2
    PCS is a 13-item questionnaire with a score range 0-52 with higher scores indicating worse status. Change score is computed by subtracting baseline PCS from PCS at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in Pain Catastrophizing Score (PCS), baseline to short-term follow-up
    PCS is a 13-item questionnaire with a score range 0-52 with higher scores indicating worse status. Change score is computed by subtracting baseline PCS from PCS at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in Pain Catastrophizing Score (PCS), baseline to intermediate-term follow-up
    PCS is a 13-item questionnaire with a score range 0-52 with higher scores indicating worse status. Change score is computed by subtracting baseline PCS from PCS at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to end of stage 1
    CPAQ-8 is an 8-item questionnaire with a score range 0-48 with higher scores indicating better status. Change score is computed by subtracting baseline CPAQ-8 score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to end of stage 2
    CPAQ-8 is an 8-item questionnaire with a score range 0-48 with higher scores indicating better status. Change score is computed by subtracting baseline CPAQ-8 score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to short-term follow-up
    CPAQ-8 is an 8-item questionnaire with a score range 0-48 with higher scores indicating better status. Change score is computed by subtracting baseline CPAQ-8 score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to intermediate-term follow-up
    CPAQ-8 is an 8-item questionnaire with a score range 0-48 with higher scores indicating better status. Change score is computed by subtracting baseline CPAQ-8 score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to end of stage 1
    PSEQ is a 10-item questionnaire with a score range 0-60 with higher scores indicating better status. Change score is computed by subtracting baseline PSEQ score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to end of stage 2
    PSEQ is a 10-item questionnaire with a score range 0-60 with higher scores indicating better status. Change score is computed by subtracting baseline PSEQ score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to short-term follow-up
    PSEQ is a 10-item questionnaire with a score range 0-60 with higher scores indicating better status. Change score is computed by subtracting baseline PSEQ score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to intermediate-term follow-up
    PSEQ is a 10-item questionnaire with a score range 0-60 with higher scores indicating better status. Change score is computed by subtracting baseline PSEQ score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Patient Activation Measure (PAM), baseline to end of stage 1
    PAM a 10-item questionnaire with a score range 10-40 with higher scores indicating better status. Change score is computed by subtracting baseline PAM score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Patient Activation Measure (PAM), baseline to end of stage 2
    PAM a 10-item questionnaire with a score range 10-40 with higher scores indicating better status. Change score is computed by subtracting baseline PAM score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Patient Activation Measure (PAM), baseline to short-term follow-up
    PAM a 10-item questionnaire with a score range 10-40 with higher scores indicating better status. Change score is computed by subtracting baseline PAM score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Patient Activation Measure (PAM), baseline to intermediate-term follow-up
    PAM a 10-item questionnaire with a score range 10-40 with higher scores indicating better status. Change score is computed by subtracting baseline PAM score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to end of stage 1
    TSK-11 an 11-item questionnaire with a score range 11-44 with higher scores indicating worse status. Change score is computed by subtracting baseline TSK-11 score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to end of stage 2
    TSK-11 an 11-item questionnaire with a score range 11-44 with higher scores indicating worse status. Change score is computed by subtracting baseline TSK-11 score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to short-term follow-up
    TSK-11 an 11-item questionnaire with a score range 11-44 with higher scores indicating worse status. Change score is computed by subtracting baseline TSK-11 score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to intermediate-term follow-up
    TSK-11 an 11-item questionnaire with a score range 11-44 with higher scores indicating worse status. Change score is computed by subtracting baseline TSK-11 score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to end of stage 1
    RMDQ a 24-item questionnaire with a score range 0-24 with higher scores indicating worse status. Change score is computed by subtracting baseline RMDQ score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to of stage 2
    RMDQ a 24-item questionnaire with a score range 0-24 with higher scores indicating worse status. Change score is computed by subtracting baseline RMDQ score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to short-term follow-up
    RMDQ a 24-item questionnaire with a score range 0-24 with higher scores indicating worse status. Change score is computed by subtracting baseline RMDQ score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to intermediate-term follow-up
    RMDQ a 24-item questionnaire with a score range 0-24 with higher scores indicating worse status. Change score is computed by subtracting baseline RMDQ score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Patient Global Impression of Change (PGIC) at end of Stage 2
    PGIC is a one-item questionnaire that determines the study subjects' assessment on their level of improvement or worsening since the start of treatment. Responses are on a likert scale from very much improved; much improved; minimally improved; no change; minimally worse; much worse; very much worse
    Change in Pyramid Measure, baseline to end of stage 1
    7-to-1 Pyramid Test is a functional performance test that measures the number of repetitions a person can do of sets of pushups, back extensions, rowers, squats, dips, and burpees. The total score is the total repetitions completed within 5 minutes. The minimum score is zero repetitions; there is no maximum number of repetitions. A higher number of repetitions indicates better functional status. Change score is computed by subtracting baseline number or repetitions from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Pyramid Measure, baseline to end of stage 2
    7-to-1 Pyramid Test is a functional performance test that measures the number of repetitions a person can do of sets of pushups, back extensions, rowers, squats, dips, and burpees. The total score is the total repetitions completed within 5 minutes. The minimum score is zero repetitions; there is no maximum number of repetitions. A higher number of repetitions indicates better functional status. Change score is computed by subtracting baseline number or repetitions from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Pyramid Measure, baseline to short-term follow-up
    7-to-1 Pyramid Test is a functional performance test that measures the number of repetitions a person can do of sets of pushups, back extensions, rowers, squats, dips, and burpees. The total score is the total repetitions completed within 5 minutes. The minimum score is zero repetitions; there is no maximum number of repetitions. A higher number of repetitions indicates better functional status. Change score is computed by subtracting baseline number or repetitions from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in Pyramid Measure, baseline to intermediate-term follow-up
    7-to-1 Pyramid Test is a functional performance test that measures the number of repetitions a person can do of sets of pushups, back extensions, rowers, squats, dips, and burpees. The total score is the total repetitions completed within 5 minutes. The minimum score is zero repetitions; there is no maximum number of repetitions. A higher number of repetitions indicates better functional status. Change score is computed by subtracting baseline number or repetitions from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of stage 1
    PROMIS Fatigue reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse fatigue. Change score is computed by subtracting baseline Fatigue T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of stage 2
    PROMIS Fatigue reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse fatigue. Change score is computed by subtracting baseline Fatigue T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of short-term follow-up
    PROMIS Fatigue reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse fatigue. Change score is computed by subtracting baseline Fatigue T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to intermediate-term follow-up
    PROMIS Fatigue reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse fatigue. Change score is computed by subtracting baseline Fatigue T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.

    Full Information

    First Posted
    November 18, 2020
    Last Updated
    November 30, 2020
    Sponsor
    Madigan Army Medical Center
    Collaborators
    U.S. Army Medical Research and Development Command, University of Washington, National Institute of Nursing Research (NINR), Henry M. Jackson Foundation for the Advancement of Military Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04656340
    Brief Title
    Complementary and Integrative Pain Therapies and Functional Restoration (IMPPPORT) Trial)
    Acronym
    IMPPPORT
    Official Title
    Enhancing the Success of Functional Restoration Using Integrative Pain Therapies: a Comparative Effectiveness Analysis of Active Duty Service Members With Chronic Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 9, 2015 (Actual)
    Primary Completion Date
    April 2, 2019 (Actual)
    Study Completion Date
    April 2, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Madigan Army Medical Center
    Collaborators
    U.S. Army Medical Research and Development Command, University of Washington, National Institute of Nursing Research (NINR), Henry M. Jackson Foundation for the Advancement of Military Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to evaluate the benefit of a complementary and integrative health (CIH) pain management program when added to standard rehabilitative care (SC) compared to SC alone prior to an intensive functional restoration (FR) program in a population of active duty service members. In addition the study aims to identify factors that predict improvement in pain impact following treatment, and to determine the proportion of participants who experience clinically meaningful response. SC included physical and occupational therapy. CIH included chiropractic, acupuncture, yoga and foam roller instruction. Both treatment groups also received education about pain psychology. Participants were randomly assigned to a 3-week course of either SC alone or CIH combined with SC prior to a 3-week course of FR. Outcomes were collected at baseline, at end of stage 1, and post-FR. Outcomes included patient-reported and provider-determined measures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    210 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard rehabilitative care (SC)
    Arm Type
    Active Comparator
    Arm Description
    Twice weekly physical therapy, occupational therapy and pain psychoeducation
    Arm Title
    Complementary and Integrative Health (CIH) therapies in addition to Standard rehabilitate care (SC)
    Arm Type
    Experimental
    Arm Description
    Twice weekly chiropractic, acupuncture, yoga and foam roller instruction, in addition to SC
    Intervention Type
    Other
    Intervention Name(s)
    non-medication, non-interventional therapies
    Other Intervention Name(s)
    Standard rehabilitative therapies (SC) and Complementary and Integrative Health (CIH) therapies
    Intervention Description
    non-medication, non-interventional therapies
    Primary Outcome Measure Information:
    Title
    Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - baseline to end of stage 1 treatment
    Description
    The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in Impact Score is computed by subtracting baseline Impact Score from the score at the time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - baseline to end of stage 2 treatment
    Description
    The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in RTF Impact Score from baseline to end of stage 2
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Secondary Outcome Measure Information:
    Title
    Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - short-term follow-up
    Description
    The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in RTF Impact Score from baseline to short-term post-treatment follow-up.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - intermediate-term follow-up
    Description
    The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in RTF Impact Score from baseline to intermediate-term post-treatment follow-up.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Battery of functional performance measures - Change in walking tolerance from baseline to end of stage 1
    Description
    Walking tolerance on a treadmill using the modified Naughton treadmill protocol. Measured in minutes completed. Higher number of minutes indicates better status. Test terminates when pain intensity increases from level at start of treadmill testing. Change score is computed by subtracting the baseline number of minutes completed from the number of minutes completed at the time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Battery of functional performance measures - Change in walking tolerance from baseline to end of stage 2
    Description
    Walking tolerance on a treadmill using the modified Naughton treadmill protocol. Measured in minutes completed. Higher number of minutes indicates better status. Test terminates when pain intensity increases from level at start of treadmill testing. Change score is computed by subtracting the baseline number of minutes completed from the number of minutes completed at the time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Battery of functional performance measures - Change in walking tolerance from baseline to short-term post-treatment follow-up.
    Description
    Walking tolerance on a treadmill using the modified Naughton treadmill protocol. Measured in minutes completed. Higher number of minutes indicates better status. Test terminates when pain intensity increases from level at start of treadmill testing. Change score is computed by subtracting the baseline number of minutes completed from the number of minutes completed at the time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Battery of functional performance measures - Change in walking tolerance from baseline to intermediate-term post-treatment follow-up
    Description
    Walking tolerance on a treadmill using the modified Naughton treadmill protocol. Measured in minutes completed. Higher number of minutes indicates better status. Test terminates when pain intensity increases from level at start of treadmill testing. Change score is computed by subtracting the baseline number of minutes completed from the number of minutes completed at the time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of Stage 1. Improvement is indicated by change scores with positive values.
    Description
    Measures how much weight in pounds study subject can comfortably lift from floor to waist height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of Stage 2
    Description
    Measures how much weight in pounds study subject can comfortably lift from floor to waist height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of short-term post-treatment follow-up
    Description
    Measures how much weight in pounds study subject can comfortably lift from floor to waist height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of intermediate-term post-treatment follow-up
    Description
    Measures how much weight in pounds study subject can comfortably lift from floor to waist height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to end of stage-1.
    Description
    Measures how much weight in pounds study subject can comfortably lift from waist to shoulder height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to end of stage-2.
    Description
    Measures how much weight in pounds study subject can comfortably lift from waist to shoulder height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to short-term post-treatment follow-up.
    Description
    Measures how much weight in pounds study subject can comfortably lift from waist to shoulder height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to intermediate-term post-treatment follow-up.
    Description
    Measures how much weight in pounds study subject can comfortably lift from waist to shoulder height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to end of stage 1
    Description
    Measures how much weight in pounds study subject can carry a distance of 40-feet. Higher number of lbs carried indicates better status. Test terminates when pain intensity increases from start of carry test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds carried from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to end of stage 2.
    Description
    Measures how much weight in pounds study subject can carry a distance of 40-feet. Higher number of lbs carried indicates better status. Test terminates when pain intensity increases from start of carry test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds carried from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to short-term post-treatment follow-up.
    Description
    Measures how much weight in pounds study subject can carry a distance of 40-feet. Higher number of lbs carried indicates better status. Test terminates when pain intensity increases from start of carry test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds carried from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to intermediate-term post-treatment follow-up.
    Description
    Measures how much weight in pounds study subject can carry a distance of 40-feet. Higher number of lbs carried indicates better status. Test terminates when pain intensity increases from start of carry test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds carried from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to end of stage 1
    Description
    PROMIS Depression reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse depression. Change score is computed by subtracting baseline Depression T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to end of stage 2
    Description
    PROMIS Depression reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse depression. Change score is computed by subtracting baseline Depression T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to short-term post-treatment follow-up
    Description
    PROMIS Depression reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse depression. Change score is computed by subtracting baseline Depression T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to intermediate-term post-treatment follow-up
    Description
    PROMIS Depression reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse depression. Change score is computed by subtracting baseline Depression T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to end of stage 1.
    Description
    PROMIS Anxiety reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anxiety T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to end of stage 2.
    Description
    PROMIS Anxiety reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anxiety T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to short-term post-treatment follow-up
    Description
    PROMIS Anxiety reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anxiety T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to intermediate-term post-treatment follow-up
    Description
    PROMIS Anxiety reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anxiety T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to end of stage 1
    Description
    PROMIS Anger reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anger T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
    Description
    PROMIS Anger reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anger T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
    Description
    PROMIS Anger reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anger T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
    Description
    PROMIS Anger reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anger T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to end of stage 1
    Description
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse Sleep-related Impairment. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to end of stage 2
    Description
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse Sleep-related Impairment. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to short-term post-treatment follow-up
    Description
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse Sleep-related Impairment. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to intermediate-term post-treatment follow-up
    Description
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse Sleep-related Impairment. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to end of stage 1.
    Description
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better physical function. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to end of stage 2.
    Description
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better physical function. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to short-term post-treatment follow-up
    Description
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better physical function. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to intermediate-term post-treatment follow-up
    Description
    PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better physical function. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to end of stage 1.
    Description
    PROMIS Satisfaction with Social Roles reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better satisfaction with social roles. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to end of stage 2
    Description
    PROMIS Satisfaction with Social Roles reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better satisfaction with social roles. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to short-term post-treatment follow-up
    Description
    PROMIS Satisfaction with Social Roles reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better satisfaction with social roles. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to intermediate-term post-treatment follow-up
    Description
    PROMIS Satisfaction with Social Roles reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better satisfaction with social roles. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Change in Pain Catastrophizing Score (PCS), baseline to end of stage 1
    Description
    PCS is a 13-item questionnaire with a score range 0-52 with higher scores indicating worse status. Change score is computed by subtracting baseline PCS from PCS at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in Pain Catastrophizing Score (PCS), baseline to end of stage 2
    Description
    PCS is a 13-item questionnaire with a score range 0-52 with higher scores indicating worse status. Change score is computed by subtracting baseline PCS from PCS at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Change in Pain Catastrophizing Score (PCS), baseline to short-term follow-up
    Description
    PCS is a 13-item questionnaire with a score range 0-52 with higher scores indicating worse status. Change score is computed by subtracting baseline PCS from PCS at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in Pain Catastrophizing Score (PCS), baseline to intermediate-term follow-up
    Description
    PCS is a 13-item questionnaire with a score range 0-52 with higher scores indicating worse status. Change score is computed by subtracting baseline PCS from PCS at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to end of stage 1
    Description
    CPAQ-8 is an 8-item questionnaire with a score range 0-48 with higher scores indicating better status. Change score is computed by subtracting baseline CPAQ-8 score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to end of stage 2
    Description
    CPAQ-8 is an 8-item questionnaire with a score range 0-48 with higher scores indicating better status. Change score is computed by subtracting baseline CPAQ-8 score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to short-term follow-up
    Description
    CPAQ-8 is an 8-item questionnaire with a score range 0-48 with higher scores indicating better status. Change score is computed by subtracting baseline CPAQ-8 score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to intermediate-term follow-up
    Description
    CPAQ-8 is an 8-item questionnaire with a score range 0-48 with higher scores indicating better status. Change score is computed by subtracting baseline CPAQ-8 score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to end of stage 1
    Description
    PSEQ is a 10-item questionnaire with a score range 0-60 with higher scores indicating better status. Change score is computed by subtracting baseline PSEQ score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to end of stage 2
    Description
    PSEQ is a 10-item questionnaire with a score range 0-60 with higher scores indicating better status. Change score is computed by subtracting baseline PSEQ score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to short-term follow-up
    Description
    PSEQ is a 10-item questionnaire with a score range 0-60 with higher scores indicating better status. Change score is computed by subtracting baseline PSEQ score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to intermediate-term follow-up
    Description
    PSEQ is a 10-item questionnaire with a score range 0-60 with higher scores indicating better status. Change score is computed by subtracting baseline PSEQ score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Change in Patient Activation Measure (PAM), baseline to end of stage 1
    Description
    PAM a 10-item questionnaire with a score range 10-40 with higher scores indicating better status. Change score is computed by subtracting baseline PAM score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in Patient Activation Measure (PAM), baseline to end of stage 2
    Description
    PAM a 10-item questionnaire with a score range 10-40 with higher scores indicating better status. Change score is computed by subtracting baseline PAM score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Change in Patient Activation Measure (PAM), baseline to short-term follow-up
    Description
    PAM a 10-item questionnaire with a score range 10-40 with higher scores indicating better status. Change score is computed by subtracting baseline PAM score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in Patient Activation Measure (PAM), baseline to intermediate-term follow-up
    Description
    PAM a 10-item questionnaire with a score range 10-40 with higher scores indicating better status. Change score is computed by subtracting baseline PAM score from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to end of stage 1
    Description
    TSK-11 an 11-item questionnaire with a score range 11-44 with higher scores indicating worse status. Change score is computed by subtracting baseline TSK-11 score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to end of stage 2
    Description
    TSK-11 an 11-item questionnaire with a score range 11-44 with higher scores indicating worse status. Change score is computed by subtracting baseline TSK-11 score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to short-term follow-up
    Description
    TSK-11 an 11-item questionnaire with a score range 11-44 with higher scores indicating worse status. Change score is computed by subtracting baseline TSK-11 score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to intermediate-term follow-up
    Description
    TSK-11 an 11-item questionnaire with a score range 11-44 with higher scores indicating worse status. Change score is computed by subtracting baseline TSK-11 score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to end of stage 1
    Description
    RMDQ a 24-item questionnaire with a score range 0-24 with higher scores indicating worse status. Change score is computed by subtracting baseline RMDQ score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to of stage 2
    Description
    RMDQ a 24-item questionnaire with a score range 0-24 with higher scores indicating worse status. Change score is computed by subtracting baseline RMDQ score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to short-term follow-up
    Description
    RMDQ a 24-item questionnaire with a score range 0-24 with higher scores indicating worse status. Change score is computed by subtracting baseline RMDQ score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to intermediate-term follow-up
    Description
    RMDQ a 24-item questionnaire with a score range 0-24 with higher scores indicating worse status. Change score is computed by subtracting baseline RMDQ score from score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Patient Global Impression of Change (PGIC) at end of Stage 2
    Description
    PGIC is a one-item questionnaire that determines the study subjects' assessment on their level of improvement or worsening since the start of treatment. Responses are on a likert scale from very much improved; much improved; minimally improved; no change; minimally worse; much worse; very much worse
    Time Frame
    End of Stage 2 timeline parameters as stated for outcomes 2
    Title
    Change in Pyramid Measure, baseline to end of stage 1
    Description
    7-to-1 Pyramid Test is a functional performance test that measures the number of repetitions a person can do of sets of pushups, back extensions, rowers, squats, dips, and burpees. The total score is the total repetitions completed within 5 minutes. The minimum score is zero repetitions; there is no maximum number of repetitions. A higher number of repetitions indicates better functional status. Change score is computed by subtracting baseline number or repetitions from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in Pyramid Measure, baseline to end of stage 2
    Description
    7-to-1 Pyramid Test is a functional performance test that measures the number of repetitions a person can do of sets of pushups, back extensions, rowers, squats, dips, and burpees. The total score is the total repetitions completed within 5 minutes. The minimum score is zero repetitions; there is no maximum number of repetitions. A higher number of repetitions indicates better functional status. Change score is computed by subtracting baseline number or repetitions from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Change in Pyramid Measure, baseline to short-term follow-up
    Description
    7-to-1 Pyramid Test is a functional performance test that measures the number of repetitions a person can do of sets of pushups, back extensions, rowers, squats, dips, and burpees. The total score is the total repetitions completed within 5 minutes. The minimum score is zero repetitions; there is no maximum number of repetitions. A higher number of repetitions indicates better functional status. Change score is computed by subtracting baseline number or repetitions from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in Pyramid Measure, baseline to intermediate-term follow-up
    Description
    7-to-1 Pyramid Test is a functional performance test that measures the number of repetitions a person can do of sets of pushups, back extensions, rowers, squats, dips, and burpees. The total score is the total repetitions completed within 5 minutes. The minimum score is zero repetitions; there is no maximum number of repetitions. A higher number of repetitions indicates better functional status. Change score is computed by subtracting baseline number or repetitions from score at time of reassessment. Improvement is indicated by change scores with positive values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of stage 1
    Description
    PROMIS Fatigue reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse fatigue. Change score is computed by subtracting baseline Fatigue T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of stage 2
    Description
    PROMIS Fatigue reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse fatigue. Change score is computed by subtracting baseline Fatigue T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of short-term follow-up
    Description
    PROMIS Fatigue reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse fatigue. Change score is computed by subtracting baseline Fatigue T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
    Title
    Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to intermediate-term follow-up
    Description
    PROMIS Fatigue reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse fatigue. Change score is computed by subtracting baseline Fatigue T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
    Time Frame
    Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Significant functional impairment due to pain, requiring modification of military duties. Physically able to participate in up to four hours of physical activity (strength, flexibility, endurance training) per day: Can stand up from and sit down on floor independently Can walk on treadmill for at least 6 minutes at 2.5 mile/hour pace or faster. Able to complete at least 2 of the following: Lift 20 lbs from floor to knuckle height Lift 20 lbs from floor to shoulder height Carry 20lbs at least 40 feet. Inadequate response to previous less intensive treatment Expresses motivation to take active role in regaining function Exclusion Criteria: Major surgeries within past 6 months or planned within next 6 months Unstable psychological disorders Active substance use disorder High dose opioids of >120 milligrams of morphine equivalent doses (MED)/day

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30582069
    Citation
    Flynn DM, McQuinn H, Fairchok A, Eaton LH, Langford DJ, Snow T, Doorenbos AZ. Enhancing the success of functional restoration using complementary and integrative therapies: Protocol and challenges of a comparative effectiveness study in active duty service members with chronic pain. Contemp Clin Trials Commun. 2018 Nov 29;13:100311. doi: 10.1016/j.conctc.2018.100311. eCollection 2019 Mar.
    Results Reference
    background
    PubMed Identifier
    34791423
    Citation
    Flynn DM, McQuinn H, Burke L, Steffen A, Fairchok A, Snow T, Doorenbos AZ. Use of Complementary and Integrative Health Therapies Before Intensive Functional Restoration in Active Duty Service Members with Chronic Pain. Pain Med. 2022 Apr 8;23(4):844-856. doi: 10.1093/pm/pnab326.
    Results Reference
    derived

    Learn more about this trial

    Complementary and Integrative Pain Therapies and Functional Restoration (IMPPPORT) Trial)

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