Restorative Exercise for Strength Training and Operational Resilience (RESTORE) for Chronic or Recurrent Low Back Pain
- Conditions
- Lower Back Pain
- Interventions
- Other: RESTORE Intervention
- Registration Number
- NCT02132910
- Lead Sponsor
- Defense and Veterans Center for Integrative Pain Management
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RESTORE Intervention RESTORE Intervention 1. 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. 2. For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor. 3. For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor. 4. 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. 5. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health.
- Primary Outcome Measures
Name Time Method Pain Scores Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up 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
1. - Hardly notice pain
2. - Notice pain, does not interfere with activities
3. - Sometimes distracts me
4. - Distracts me, can do usual activities
5. - Interrupts some activities
6. - Hard to ignore, avoid usual activities
7. - Focus of attention, prevents doing daily activities
8. - Awful, hard to do anything
9. - Can't bear pain, unable to do anything
10. - As bad as it could be, nothing else matters
Higher values represent worse outcomes
- Secondary Outcome Measures
Name Time Method Disability Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up 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
Trial Locations
- Locations (1)
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States