Overview

This trial is active, not recruiting.

Condition lower back pain
Treatment restore intervention
Sponsor Defense and Veterans Center for Integrative Pain Management
Start date December 2013
End date August 2015
Trial size 68 participants
Trial identifier NCT02132910, 380491

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
restore intervention
(No Intervention)
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.

Primary Outcomes

Measure
Pain Scores-DVPRS 2.0
time frame: Weekly for 6 weeks

Secondary Outcomes

Measure
Roland Morris Disability Questionnaire (RMDQ)
time frame: Week 0, Week 4, Week 8, 3 month, 6 monthq

Eligibility Criteria

Male or female participants from 18 years up to 68 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Defense and Veterans Center for Integrative Pain Management.