Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury
Primary Purpose
Chronic Pain
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Complementary and Integrative Therapies
Standard Rehabilitative Care
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Military
Eligibility Criteria
Inclusion Criteria:
- Active duty service members
- Neuromusculoskeletal or neuropathic pain ≥ 3-months duration
- Pain of sufficient severity to bring about dysfunction in daily social, vocational, and/or interpersonal activities
Exclusion Criteria:
- Major surgeries within past 6 months or planned within next 6 months
- Unstable psychological disorders
- Active substance use disorder
Sites / Locations
- Madigan Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Complementary and Integrative Therapies
Standard Rehabilitative Care
Arm Description
Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction
Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy
Outcomes
Primary Outcome Measures
Change from Baseline Pain Intensity
Pain Intensity 10-pt Numeric Rating Scale
Change from Baseline Pain Impact
Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)
Secondary Outcome Measures
Depression
Patient Reported Outcome Measurement Information System
Anxiety
Patient Reported Outcome Measurement Information System
Emotional Distress - Anger
Patient Reported Outcome Measurement Information System
Sleep Disturbance
Patient Reported Outcome Measurement Information System
Fatigue
Patient Reported Outcome Measurement Information System
PTSD
Primary Care PTSD Screen
Patient Activation Measure
A 22-item survey that addresses four stages of patient activation: (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress. Patients are asked to agree or not to agree with each of the 22 items.
Drug Use
Drug Use Questionnaire
Pain Catastrophizing
Pain Catastrophizing Scale
Kinesiophobia
Tampa Scale for Kinesiophobia
Pain Self-Efficacy
Pain Self Efficacy Questionnaire
Chronic Pain Acceptance
Chronic Pain Acceptance Questionnaire
Functional Capacity
Roland-Morris Disability Questionnaire and Canadian Occupational Performance Measure
Opioid Utilization
Opioid Utilization Screener
Cortisol
Salivary Cortisol
Oxidative Stress
Urine Sample
Genomic DNA
Buccal Sample
Army Physical Fitness Test (APFT)
Passing scores of 60 on all 3 components (push-ups, sit-ups, 2-mile run) of the APFT will be operationalized as "force-readiness".
Full Information
NCT ID
NCT03297905
First Posted
August 8, 2017
Last Updated
October 10, 2022
Sponsor
University of Washington
Collaborators
Madigan Army Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03297905
Brief Title
Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury
Official Title
Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Madigan Army Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will (1) compare the effectiveness of standard rehabilitative pain care with complementary and integrative pain therapies; (2) identify subgroups of patients who do and do not respond to the intervention(s); (3) determine the most effective sequencing of the interventions; and (4) determine factors associated with treatment response that can be implemented to support clinical decision-making.
Detailed Description
Objectives and Rationale. Pain due to neuromusculoskeletal injuries is a leading cause of disability among active duty military Service members. The injury rate is significant with 628 neuromusculoskeletal injuries per 1000 person-years among active duty military Service members. Neuromusculoskeletal injuries include amputations following battlefield trauma, repetitive motion injuries related to equipment use or weight-bearing postures, and even injuries or strains incurred during off-duty pursuits. Regardless of cause, the effects on both individual Service members and military readiness are significant: Only 13% of Service members being treated primarily for pain ever return to the field.
The Department of Defense (DoD) has recently expanded its capacity to provide both functional restoration (FR) and complementary and integrative medicine (CIM) therapies for neuromusculoskeletal injury, pain, and disability. The proposed research aims to determine the most effective treatment combination, sequence, and duration of standard rehabilitative care (SRC), such as physical and occupational therapy in combination with cognitive behavioral therapy and CIM therapies, such as acupuncture and chiropractic, for Service members preparing to enroll in an intensive FR program that is currently the DoD-recommended treatment. In addition, this study aims to identify ways to predict in advance which patients will respond best to which therapeutic regimens.
Potential Impact. This research has the potential to determine which patients are most likely to benefit from the non-medication pain therapies currently available in all Army Interdisciplinary Pain Management Centers (IPMC) and how these therapies can most effectively be combined to achieve the greatest improvements in pain impact, quality of life and ability to return to duty following injury.
Patients Who Will Benefit. This study will involve active duty Service members referred to an Army IPMC. The results will be shared with other Military Health System (MHS) and Veterans Health Administration (VHA) pain management centers so that active duty Service members and veterans across United States may benefit from a treatment approach that is tailored to their individual characteristics. It is anticipated that the knowledge gained through this research will be applicable to family members of Service members and veterans and will ultimately lead to expansion of TRICARE benefits to include CIM therapies.
Potential Clinical Applications, Benefits, and Risks. This research will assist providers in determining when to refer their patients with neuromusculoskeletal pain for SRC and/or CIM therapies prior to FR. It will assist IPMCs in developing treatment plans tailored to the needs of each patient. Service members and veterans will benefit by being referred for these approaches when appropriate during the course of disabling chronic pain conditions. Ultimately, it is hoped that decision tools can be imbedded in the electronic medical record to guide health care providers to consider referral for these therapies in patients who may benefit. This study will advance our ability to effectively tailor therapies for rehabilitation from neuromusculoskeletal pain for different patients to yield the greatest benefit in physical function and quality of life. The risks of these interventions are minimal; Service members may experience general muscle soreness for the first week or so of increased physical activity, but this typically resolves.
Projected Timeline. This research will determine the optimal combination, sequence, and duration of therapies. It is expected that some active duty Service members could see improvements in function and quality of life within three weeks, but others may require up to six weeks to experience meaningful improvement.
Benefit to Military Personnel. This research will benefit Service members experiencing pain due to neuromusculoskeletal injury. It will identify ways to direct them to the therapies most likely to yield meaningful improvements in function and quality of life, and thus facilitate their return to duty. The recommendations from this study will be shared with pain management centers throughout the DoD, VHA; and, we hope, eventually to TRICARE members.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic Pain, Military
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Sequential Multiple Assignment Randomized Trial (SMART)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Complementary and Integrative Therapies
Arm Type
Experimental
Arm Description
Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction
Arm Title
Standard Rehabilitative Care
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy
Intervention Type
Behavioral
Intervention Name(s)
Complementary and Integrative Therapies
Intervention Description
Intervention time period is 3 - 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Standard Rehabilitative Care
Intervention Description
Intervention time period is 3 - 6 weeks.
Primary Outcome Measure Information:
Title
Change from Baseline Pain Intensity
Description
Pain Intensity 10-pt Numeric Rating Scale
Time Frame
3 months
Title
Change from Baseline Pain Impact
Description
Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Depression
Description
Patient Reported Outcome Measurement Information System
Time Frame
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Title
Anxiety
Description
Patient Reported Outcome Measurement Information System
Time Frame
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Title
Emotional Distress - Anger
Description
Patient Reported Outcome Measurement Information System
Time Frame
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Title
Sleep Disturbance
Description
Patient Reported Outcome Measurement Information System
Time Frame
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Title
Fatigue
Description
Patient Reported Outcome Measurement Information System
Time Frame
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Title
PTSD
Description
Primary Care PTSD Screen
Time Frame
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Title
Patient Activation Measure
Description
A 22-item survey that addresses four stages of patient activation: (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress. Patients are asked to agree or not to agree with each of the 22 items.
Time Frame
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Title
Drug Use
Description
Drug Use Questionnaire
Time Frame
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Title
Pain Catastrophizing
Description
Pain Catastrophizing Scale
Time Frame
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Title
Kinesiophobia
Description
Tampa Scale for Kinesiophobia
Time Frame
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Title
Pain Self-Efficacy
Description
Pain Self Efficacy Questionnaire
Time Frame
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Title
Chronic Pain Acceptance
Description
Chronic Pain Acceptance Questionnaire
Time Frame
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Title
Functional Capacity
Description
Roland-Morris Disability Questionnaire and Canadian Occupational Performance Measure
Time Frame
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Title
Opioid Utilization
Description
Opioid Utilization Screener
Time Frame
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Title
Cortisol
Description
Salivary Cortisol
Time Frame
baseline, 6 weeks
Title
Oxidative Stress
Description
Urine Sample
Time Frame
baseline, 6 weeks
Title
Genomic DNA
Description
Buccal Sample
Time Frame
baseline
Title
Army Physical Fitness Test (APFT)
Description
Passing scores of 60 on all 3 components (push-ups, sit-ups, 2-mile run) of the APFT will be operationalized as "force-readiness".
Time Frame
baseline, 6 weeks, 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active duty service members
Neuromusculoskeletal or neuropathic pain ≥ 3-months duration
Pain of sufficient severity to bring about dysfunction in daily social, vocational, and/or interpersonal activities
Exclusion Criteria:
Major surgeries within past 6 months or planned within next 6 months
Unstable psychological disorders
Active substance use disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ardith Z Doorenbos, RN, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury
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