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

Study Overview
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Brief Summary
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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.

Official Title
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Restorative Exercise for Strength Training and Operational Resilience

Conditions
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Lower Back Pain

Intervention / Treatment
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* Other: RESTORE Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RESTORE Intervention<br>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. | Other: RESTORE Intervention<br> <br> |
| No Intervention: Control Group 2<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up |