Clinical trial NCT02132910: Restorative Exercise for Strength Training and Operational Resilience (RESTORE) for Chronic or Recurrent Low Back Pain
Official title: Restorative Exercise for Strength Training and Operational Resilience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Back Pain
Lead sponsor: Defense and Veterans Center for Integrative Pain Management
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Pain Scores
timeFrame: Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up
Secondary outcomes:
measure: Disability
timeFrame: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up
Other outcomes:
measure: Physical Functioning
timeFrame: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up
measure: Symptom Burden
timeFrame: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Defense and Veterans Center for Integrative Pain Management
name: Chester Buckenmaier, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.