Yoga for Veterans With CLBP

NCT ID: NCT02524158

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-12-31

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Yoga

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.

Group Type: EXPERIMENTAL

Yoga Therapy for CLBP

Intervention Type: BEHAVIORAL

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.

Delayed Treatment Control - Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik J Groessl, PhD BA BS

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Locations

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32826784 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28735778 (View on PubMed)

Other Identifiers

O7768-R

Identifier Type: -

Identifier Source: org_study_id