Yoga for Veterans With CLBP

NCT02524158 | Completed Results

• 1 other identifier: O7768-R
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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

Keywords

Yoga; Mind-Body Therapies; Chronic Low Back Pain; Military Veterans; VA patients

Outcome Measures

Primary Outcomes (2)

• Roland-Morris Disability Questionnaire

  The primary outcomes is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline and 12-weeks. 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.

  baseline to 12 weeks

• Roland-Morris Disability Questionnaire

  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.

  baseline to 6-months

Secondary Outcomes (16)

• Change From Baseline in Pain Intensity - Brief Pain Inventory at 12 Weeks

  baseline to 12 weeks

• Change From Baseline in Pain Intensity - Brief Pain Inventory at 6 Months

  baseline to 6 months

• Change From Baseline Pain Interference - Brief Pain Inventory at 12 Weeks

  baseline to 12 weeks

• Change From Baseline - Fatigue Severity Scale (FSS) at 12 Weeks

  baseline to 12 weeks

• Change From Baseline - SF12 PCS at 12 Weeks

  baseline to 12 weeks

Study Arms (2)

Yoga

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.

Behavioral: Yoga Therapy for CLBP

Delayed Treatment Control - Usual Care

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.

Interventions

Yoga Therapy for CLBP 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.

Yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Related Publications (2)

• 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.

  PMID: 32826784 DERIVED

• 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.

  PMID: 28735778 DERIVED

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Results Point of Contact

• Title: Dr. Erik J. Groessl
• Organization: VA San Diego

erik.groessl@va.gov

858-552-8585

Study Officials

• Erik J Groessl, PhD BA BS

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 14, 2015
• Study Start: April 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: December 31, 2016
• Last Updated: October 10, 2018
• Results First Posted: October 9, 2017

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)