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Restorative Exercise for Strength Training and Operational Resilience (RESTORE) for Chronic or Recurrent Low Back Pain (RESTORE)

Primary Purpose

Lower Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RESTORE Intervention
Sponsored by
Defense and Veterans Center for Integrative Pain Management
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lower Back Pain

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with lower back pain with a pain score of 4 or higher on DVPRS for 3 months
  • Male or female
  • Age 18-68*
  • Able to read and understand English
  • Understands language, and able to report current pain levels and recall events
  • DEERS-Eligible, Military healthcare beneficiary

Exclusion Criteria:

  • Provider has advised against mild to moderate exercise
  • Patient unable to sit on the floor for two minutes or unable to stand independently
  • Complex Regional Pain Syndrome, Fibromyalgia, Chronic Fatigue Syndrome, Auto Immune disease-related pain, other chronic medical conditions (i.e. advanced diabetic neuropathies) that preclude consent
  • Patients with severe TBI
  • Practiced Yoga within 6 months
  • Pre-surgical candidates for back surgery within 3 months
  • Back surgery within the past year
  • Pregnancy**; females will be asked to self-report
  • Undergoing Medical Evaluation Board to determine discharge

Sites / Locations

  • Walter Reed National Military Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RESTORE Intervention

Control Group 2

Arm Description

First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about yourself, your pain and your current medication use. For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor. For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor. At weeks four and eight, you will repeat the assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health.

First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform so simple physical assessments, and answer questions about yourself, your pain and your current medication use. You will be contacted once a week for eight weeks by phone or email to answer questions about your pain level. At weeks four and eight, you will repeat the assessment of pain, physical function and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavior health.

Outcomes

Primary Outcome Measures

Pain Scores
Participants will choose a pain score using the Defense and Veteran's Pain Rating Scale 2.0 Rate the severity of your CURRENT pain: 0 - No Pain - Hardly notice pain - Notice pain, does not interfere with activities - Sometimes distracts me - Distracts me, can do usual activities - Interrupts some activities - Hard to ignore, avoid usual activities - Focus of attention, prevents doing daily activities - Awful, hard to do anything - Can't bear pain, unable to do anything - As bad as it could be, nothing else matters Higher values represent worse outcomes

Secondary Outcome Measures

Disability
The Roland Morris Disability Questionnaire is reliable at measuring level of disability and is sensitive to change over time for groups of patients with lower back pain. Scale: 0-24 (24 total statements) -Greater levels of disability are reflected by higher numbers on a 24-point scale See link for complete statements: https://www.worksafe.qld.gov.au/__data/assets/pdf_file/0009/76851/roland-morris-low-back-pain-and-disability-questionnaire-rmq1.pdf

Full Information

First Posted
May 6, 2014
Last Updated
November 6, 2019
Sponsor
Defense and Veterans Center for Integrative Pain Management
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1. Study Identification

Unique Protocol Identification Number
NCT02132910
Brief Title
Restorative Exercise for Strength Training and Operational Resilience (RESTORE) for Chronic or Recurrent Low Back Pain
Acronym
RESTORE
Official Title
Restorative Exercise for Strength Training and Operational Resilience
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 7, 2015 (Actual)
Study Completion Date
August 7, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Defense and Veterans Center for Integrative Pain Management

4. Oversight

5. Study Description

Brief Summary
The purpose of the study is to learn about the effect of integrative therapies on chronic or recurrent low back pain. The intervention called RESTORE (Restorative Exercises for Strength Training and Operational Resilience) is based on a series of gentle stretching and strengthening exercises incorporating breath-work and mindfulness. The study is designed to discover the impact of RESTORE on pain levels, physical function, and behavioral health.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RESTORE Intervention
Arm Type
Experimental
Arm Description
First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about yourself, your pain and your current medication use. For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor. For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor. At weeks four and eight, you will repeat the assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health.
Arm Title
Control Group 2
Arm Type
No Intervention
Arm Description
First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform so simple physical assessments, and answer questions about yourself, your pain and your current medication use. You will be contacted once a week for eight weeks by phone or email to answer questions about your pain level. At weeks four and eight, you will repeat the assessment of pain, physical function and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavior health.
Intervention Type
Other
Intervention Name(s)
RESTORE Intervention
Primary Outcome Measure Information:
Title
Pain Scores
Description
Participants will choose a pain score using the Defense and Veteran's Pain Rating Scale 2.0 Rate the severity of your CURRENT pain: 0 - No Pain - Hardly notice pain - Notice pain, does not interfere with activities - Sometimes distracts me - Distracts me, can do usual activities - Interrupts some activities - Hard to ignore, avoid usual activities - Focus of attention, prevents doing daily activities - Awful, hard to do anything - Can't bear pain, unable to do anything - As bad as it could be, nothing else matters Higher values represent worse outcomes
Time Frame
Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up
Secondary Outcome Measure Information:
Title
Disability
Description
The Roland Morris Disability Questionnaire is reliable at measuring level of disability and is sensitive to change over time for groups of patients with lower back pain. Scale: 0-24 (24 total statements) -Greater levels of disability are reflected by higher numbers on a 24-point scale See link for complete statements: https://www.worksafe.qld.gov.au/__data/assets/pdf_file/0009/76851/roland-morris-low-back-pain-and-disability-questionnaire-rmq1.pdf
Time Frame
Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up
Other Pre-specified Outcome Measures:
Title
Physical Functioning
Description
Physical functioning was assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Functioning subscale (0-100) Total scores are transformed to standardized t scores (mean=50; SD=10). Higher scores indicate higher physical functioning.
Time Frame
Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up
Title
Symptom Burden
Description
Symptom burden was assessed using the PROMIS-29 Sleep Disturbance, Pain Interference, Anxiety, Depression, and Fatigue subscales (0-100) Subscales are averaged into a composite score.The Composite scale ranges from 0 to 100, with higher scores indicating higher symptom burden.
Time Frame
Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with lower back pain with a pain score of 4 or higher on DVPRS for 3 months Male or female Age 18-68* Able to read and understand English Understands language, and able to report current pain levels and recall events DEERS-Eligible, Military healthcare beneficiary Exclusion Criteria: Provider has advised against mild to moderate exercise Patient unable to sit on the floor for two minutes or unable to stand independently Complex Regional Pain Syndrome, Fibromyalgia, Chronic Fatigue Syndrome, Auto Immune disease-related pain, other chronic medical conditions (i.e. advanced diabetic neuropathies) that preclude consent Patients with severe TBI Practiced Yoga within 6 months Pre-surgical candidates for back surgery within 3 months Back surgery within the past year Pregnancy**; females will be asked to self-report Undergoing Medical Evaluation Board to determine discharge
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chester Buckenmaier, MD
Organizational Affiliation
Defense and Veterans Center for Integrative Pain Management
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28919191
Citation
Highland KB, Schoomaker A, Rojas W, Suen J, Ahmed A, Zhang Z, Carlin SF, Calilung CE, Kent M, McDonough C, Buckenmaier CC 3rd. Benefits of the Restorative Exercise and Strength Training for Operational Resilience and Excellence Yoga Program for Chronic Low Back Pain in Service Members: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jan;99(1):91-98. doi: 10.1016/j.apmr.2017.08.473. Epub 2017 Sep 14. Erratum In: Arch Phys Med Rehabil. 2018 Apr;99(4):777.
Results Reference
derived
Links:
URL
http://www.dvcipm.org/research/studies/
Description
Defense and Veterans Center for Integrative Pain Management Website
URL
http://www.dvcipm.org/clinical-resources/defense-veterans-pain-rating-scale-dvprs/
Description
Defense and Veterans Pain Rating Scale

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Restorative Exercise for Strength Training and Operational Resilience (RESTORE) for Chronic or Recurrent Low Back Pain

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