Clinical trial NCT02524158: Yoga for Veterans With CLBP
Official title: Yoga Therapy to Improve Function Among Veterans With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Yoga
Mind-Body Therapies
Chronic Low Back Pain
Military Veterans
VA patients
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-08-14
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Roland-Morris Disability Questionnaire
timeFrame: baseline to 12 weeks
measure: Roland-Morris Disability Questionnaire
timeFrame: baseline to 6-months
Secondary outcomes:
measure: Change From Baseline in Pain Intensity - Brief Pain Inventory at 12 Weeks
timeFrame: baseline to 12 weeks
measure: Change From Baseline in Pain Intensity - Brief Pain Inventory at 6 Months
timeFrame: baseline to 6 months
measure: Change From Baseline Pain Interference - Brief Pain Inventory at 12 Weeks
timeFrame: baseline to 12 weeks
measure: Change From Baseline - Fatigue Severity Scale (FSS) at 12 Weeks
timeFrame: baseline to 12 weeks
measure: Change From Baseline - SF12 PCS at 12 Weeks
timeFrame: baseline to 12 weeks
measure: Change From Baseline - SF12 MCS at 12 Weeks
timeFrame: baseline to 12 weeks
measure: Change From Baseline - EuroQOL 5D (EQ5D) at 12 Weeks
timeFrame: baseline to 12 weeks
measure: Change From Baseline - Center for Epidemiologic Studies Short Depression Scale (CES-D 10) at 12 Weeks
timeFrame: baseline to 12 weeks
measure: Change From Baseline - Brief Anxiety Inventory (BAI) at 12 Weeks
timeFrame: baseline to 12 weeks
measure: Change From Baseline - Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks
timeFrame: baseline to 12 weeks
measure: Change From Baseline - Self-efficacy for Managing Low Back Pain at 12 Weeks
timeFrame: baseline to 12 weeks
measure: Attendance/ Home Practice
timeFrame: 12 weeks
measure: Change From Baseline - Range of Motion - Flexion at 12 Weeks
timeFrame: baseline to 12 weeks
measure: Change From Baseline - Grip Strength at 12 Weeks
timeFrame: baseline to 12 weeks
measure: Change From Baseline - Lower Limb Strength and Balance - Eyes Open at 12 Weeks
timeFrame: baseline to 12 weeks
measure: Change From Baseline - Lower Spine Stabilization - Core Strength at 12 Weeks
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Erik J Groessl, PhD BA BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Groessl EJ, Liu L, Richard EL, Tally SR. Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans. Med Care. 2020 Sep;58 Suppl 2 9S:S142-S148. doi: 10.1097/MLR.0000000000001356.
citation: Groessl EJ, Liu L, Chang DG, Wetherell JL, Bormann JE, Atkinson JH, Baxi S, Schmalzl L. Yoga for Military Veterans with Chronic Low Back Pain: A Randomized Clinical Trial. Am J Prev Med. 2017 Nov;53(5):599-608. doi: 10.1016/j.amepre.2017.05.019. Epub 2017 Jul 20.