Chronic Low Back PainNCT07053787
Durability of Yoga for Veterans With Low Back Pain
A study testing Standard Yoga and Enhanced Yoga in people with Chronic Low Back Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Chronic low back pain is a prevalent condition among VA patients, but many current treatment options have side effects or limited effectiveness. Veterans with chronic low back pain (cLBP) experience increased disability, functional challenges, and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Standard Yoga and Enhanced Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Dec 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VA patients
- Diagnosis of chronic low back pain > 3 months
- Pain rated 4/10 or higher
- No new pain treatments in the past month
- Willing to attend intervention
- Complete 5 assessments
Show all 9Show fewer
- Respond to text assessments
- Practiced yoga < 3x in the last 6 months
- Unless medically necessary, agree to not change pain treatment during intervention
Who cannot join
- Back surgery within the last 1 year
- Pain due to specific systemic (e.g., scleroderma, fibromyalgia) or non-musculoskeletal problem (neuropathy)
- Positive Romberg test (with or without sensory neuropathy)
- Severe vertebral disk problems, sciatica or nerve compression >3 months
- Serious or unstable psychiatric illness (e.g., unmanaged psychosis, manic episode, or substance dependence)
- Serious coexisting medical illness (e.g., cancer, chronic obstructive pulmonary disease (COPD), body mass index (BMI)> 40)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Niloofar Afari, PhD, (858) 642-3657, Niloofar.Afari@va.gov
Carl J Stepnowsky, Jr., PhD, (858) 642-1240, Carl.Stepnowsky@va.gov
About this study
Official title: Durability of Yoga for Treating Veterans With Chronic Low Back Pain
Chronic low back pain is a prevalent condition among VA patients, but many current treatment options have side effects or limited effectiveness. Veterans with chronic low back pain (cLBP) experience increased disability, functional challenges, and reduced quality of life. A prior VA funded study of Yoga for VA patients with cLBP found that yoga can reduce pain and disability at 3 and 6 months after enrollment. However, the long-term effects and maintenance of yoga practice is unknown. The current study will test an intervention designed to promote long-term yoga practice and long-term health outcome benefits at 12 and 18 months after enrollment.
Read the detailed description
Significance to VA:
Chronic low back pain (cLBP) is a highly prevalent condition for Veterans. In addition to chronic pain, cLBP leads to significant amounts of disability, reduced health-related quality of life (QOL), and increased health care utilization. Our previous results and other studies of yoga for Veterans with cLBP show that yoga participants had reduced pain and disability at follow-up assessments at 6-month follow-up. There is also some evidence indicating that self-care treatments like yoga, especially those provided in group format, may be less expensive and may reduce health care costs, conserving limited resources for other conditions and services. Since persons with cLBP usually live with this chronic condition for the rest of their lives, understanding and facilitating long-term yoga practice for VA patients is an important step for the provision of high-quality VA healthcare.
Innovation and Impact:
If funded, this will be the first study to examine a durability intervention for promoting long-term yoga practice. It uses text messaging for both behavioral reminders, and for ecological momentary assessment of the durability outcome. The study tracks 18 months of follow-up data.
Specific Aims:
The primary aims of the proposed project are to examine the effectiveness of a coaching intervention plus text reminders for promoting long-term maintenance of yoga practice and function among Veterans with cLBP. The investigators will also examine intervention costs and subsequent health care costs.
Methodology:
The investigators will recruit and randomize 176 Veterans with cLBP to either standard yoga or the durability-enhanced yoga intervention. Participants will complete health outcome assessments at baseline, 3 months, 6 months, 12 months, and 18 months. The standard yoga intervention includes weekly in- person yoga sessions for 12 weeks. The enhanced yoga arm will receive weekly behavioral coaching sessions from weeks 10-15 and will receive ongoing text reminders. The co-primary outcomes will be the mean days and minutes per week of yoga practice and the mean change in back pain-related disability at 12 months. The investigators will measure yoga practice and other health outcomes including pain severity, QOL, and fatigue through 18 months. The investigators will measure attendance and home practice. The investigators will monitor and assess adverse events and instructor fidelity.
Path to Translation/Implementation:
If the durability intervention can increase long-term yoga practice and associated health benefits, this will provide very strong evidence for wider implementation of yoga as a specific treatment for chronic low back pain.
- Conditions
- Chronic Low Back Pain
- Being tested
- Standard Yoga, Enhanced Yoga
- Keywords
- chronic low back pain, yoga, disability, durability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard YogaBehavioural
Weekly hatha yoga for 12 weeks augmented by home practice guided by yoga instructional videos.
Enhanced YogaBehavioural
Weekly hatha yoga for 12 weeks augmented by home practice guided by yoga instructional videos plus six weekly 50-minute 1-on-1 coaching sessions starting week 10 of the standard yoga intervention and ending week 15 (3 weeks after end of standard yoga). During this transition, participants are supported with development and execution of their plan for continuing their yoga practice. Participants will be offered 1 additional ad-hoc coaching session to help them re-start yoga if they get off track and/or experience major life events such as moving, job change, medical issues, etc.
| Study group | Role | What they receive |
|---|---|---|
| Standard Yoga | Active comparator | Hatha yoga designed for Veterans with chronic low back pain. Receives: Behavioral: Standard Yoga |
| Enhanced Yoga | Experimental | Hatha yoga designed for Veterans with chronic low back pain plus coaching and texts to enhance durability and long-term adherence to yoga. Receives: Behavioral: Enhanced Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days and minutes per week of yoga practice - Ecological Momentary Assessment (EMA) of Yoga
The investigators will employ EMA to assess weekly yoga practices across the whole 18-month study period. Because yoga includes both mind and body components, as well as movements that are not aerobic in nature, yoga cannot be assessed like other physical activities using accelerometers. EMA has been shown to enhance self-report because it occurs randomly, so as not subject to recall bias, and frequently so is not subject to recall errors. The investigators will ask how many minutes of yoga, if any, have been performed on the assessment day and whether it was performed at home or at an in-person class. Participants will receive an EMAs every week across the 18-monthstudy period. If participants do not respond within 90 minutes, a reminder will be sent. If there is still no response, they will be sampled again in the next 24 hours at a different time of day.
Measured: Baseline to 18 months
Roland-Morris Disability Questionnaire (RMDQ)
The RMDQ will serve as the primary health outcome and consists of 23 questions about limitations experienced for a variety of daily activities. The scale has been shown to be reliable and is well validated. It has been used in other studies of yoga studies. Scores range from 0 to 23, with higher scores indicating more back pain-related disability.
Measured: Change from baseline to 18 months
Secondary outcomes (5)
Pain Severity - Brief Pain Inventory (BPI)
This subscale assesses pain severity using a Numeric Rating Scale (NRS) from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. The mean of multiple items is used. Higher mean scores indicate greater pain severity.
Measured: Change from baseline to 18 months
Pain Interfernce - Brief Pain Inventory (BPI)
This subscale assesses pain interference using a Numeric Rating Scale (NRS) from 0 to 10, where 0 is no pain and 10 is the worst pain interference imaginable. The mean of multiple items is used. Higher mean scores indicate greater pain interference.
Measured: Change from baseline to 18 months
Fatigue - Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) has a score range of 9 to 63. Higher scores indicates more severe fatigue.
Measured: Change from baseline to 18 months
Quality of Life (QOL)- SF12
Physical and mental quality of life (QOL) will be assessed with the Short-form 12 (SF12). The SF-12 uses a norm-based scoring system, where the mean score for the general population is 50, and standard deviation is 10. Scores range from 0 to 100, with higher scores indicating better QOL/ health status.
Measured: Change from baseline to 18 months
Yoga Self-Efficacy Scale (YSES)
YSES scores range from 12 to 108, with higher scores indicating greater perceived self-efficacy in yoga practice.
Measured: Change from baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Erik J. Groessl, PhD BA BS, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053787
- Sponsor's protocol ID
- RRD2-001-24W
- Status last verified
- Aug 2026
- First submitted
- 27 Jun 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be created and shared.