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

Defense and Veterans Center for Integrative Pain Management68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Lower Back Pain

Interventions

RESTORE InterventionOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 68 Years

Medical Language ↔ Plain English

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

Locations (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Outcomes

Primary Outcomes

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 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

Time frame: Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up

Secondary Outcomes

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

Time frame: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up

Data from ClinicalTrials.gov

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