Overview

This trial has been completed.

Condition chronic low back pain
Treatment yoga therapy for clbp
Sponsor VA Office of Research and Development
Start date April 2013
End date April 2016
Trial size 152 participants
Trial identifier NCT02524158, O7768-R

Summary

Chronic low back pain (CLBP) is a prevalent condition among VA patients, but many current treatment options have limited effectiveness. In addition to chronic pain, people with chronic low back pain experience increased disability, psychological symptoms such as depression, and reduced health-related quality of life. This randomized controlled study will examine the impact of yoga therapy for improving function and decreasing pain in VA patients with chronic low back pain. Although not every VA patient with chronic low back pain will choose to do yoga, it is an inexpensive treatment modality that is increasingly appealing to many VA patients. If yoga is effective, it could become an additional low-cost option that the VA can offer to better serve Veterans with chronic low back pain.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking outcomes assessor
Arm
(Experimental)
The yoga intervention will consist of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
yoga therapy for clbp
Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
(No Intervention)
Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.

Primary Outcomes

Measure
Roland-Morris Disability Questionnaire
time frame: baseline, 12 weeks, 6 months

Secondary Outcomes

Measure
Pain Intensity - Brief Pain Inventory
time frame: baseline, 12 weeks, 6 months
Pain Interference - Brief Pain Inventory
time frame: baseline, 12 weeks, 6 months
Center for Epidemiologic Studies Short Depression Scale (CES-D 10)
time frame: baseline, 12 weeks, 6 months
Brief Anxiety Inventory (BAI)
time frame: baseline, 12 weeks, 6 months
Short-form 12 (SF12)
time frame: baseline, 12 weeks, 6 months
Self-efficacy for managing low back pain
time frame: baseline, 12 weeks, 6 months
Fatigue Severity Scale (FSS)
time frame: baseline, 12 weeks, 6 months
Attendance/ Home practice
time frame: total # of sessions attended at end of 12 week intervention
Range of Motion
time frame: baseline, 12 weeks, 6 months
Grip Strength
time frame: baseline, 12 weeks, 6 months
Lower Limb Strength and Balance
time frame: baseline, 12 weeks, 6 months
Lumbar Spine Stabilization Endurance
time frame: baseline, 12 weeks, 6 months

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: - Has a VA primary care provider - Diagnosis of chronic low back pain > 6 months - Willing to attend a yoga program or be assigned to delayed treatment with yoga - Willing to complete 4 assessments - English Literacy - Has not begun new pain treatments or medications in the past month - Willing to not change pain treatments (e.g., discontinue a treatment; increase medication dose) during the 12-week intervention period unless medically necessary Exclusion Criteria: - back surgery within the last 12 months - back pain due to specific systemic problem (eg, lupus, scleroderma, fibromyalgia) - morbid obesity (BMI > 40) - Significant sciatica or nerve compression < 3 months or chronic lumbar radicular pain > 3 months - Unstable, serious coexisting medical illness (eg, CHF, cancer, COPD, morbid obesity; dementia) - Unstable, serious psychiatric illness (e.g., unmanaged psychosis, active substance dependence) - Insufficient data to rule out acute, metastatic disease, (unless primary care physician approves) - Attended or practiced yoga > 1x in the last 12 months - Positive Romberg test (with or without sensory neuropathy)

Additional Information

Official title Yoga Therapy to Improve Function Among Veterans With Chronic Low Back Pain
Principal investigator Erik J Groessl, PhD BA BS
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.