Yoga Therapy to Improve Function Among Veterans With Chronic Low Back Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Low Back Pain
- Sponsor
- VA Office of Research and Development
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- Roland-Morris Disability Questionnaire
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Roland-Morris Disability Questionnaire
Time Frame: baseline to 6-months
The primary outcome is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline, 12-weeks, and 6-months. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.
Secondary Outcomes
- Change From Baseline in Pain Intensity - Brief Pain Inventory at 6 Months(baseline to 6 months)
- Change From Baseline - Center for Epidemiologic Studies Short Depression Scale (CES-D 10) at 12 Weeks(baseline to 12 weeks)
- Change From Baseline in Pain Intensity - Brief Pain Inventory at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - SF12 PCS at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - Self-efficacy for Managing Low Back Pain at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - Fatigue Severity Scale (FSS) at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - EuroQOL 5D (EQ5D) at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - Range of Motion - Flexion at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks(baseline to 12 weeks)
- Attendance/ Home Practice(12 weeks)
- Change From Baseline - Lower Spine Stabilization - Core Strength at 12 Weeks(baseline to 12 weeks)
- Change From Baseline Pain Interference - Brief Pain Inventory at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - SF12 MCS at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - Brief Anxiety Inventory (BAI) at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - Grip Strength at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - Lower Limb Strength and Balance - Eyes Open at 12 Weeks(baseline to 12 weeks)