N/A N=68 Randomized Supportive Care

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

Lower Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT02132910 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Pain Scores — 4.32; 4.68; 3.97; 2.60 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: RESTORE Intervention (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Defense and Veterans Center for Integrative Pain Management
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Scores	4.32; 4.68; 3.97; 2.60; 3.67; 2.48	—
SECONDARY Disability	8.68; 9.21; 8.03; 5.90; 6.70; 4.41	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02132910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.