Yoga for Chronic Lower Back Pain

Overseen By Erik J Groessl, PhD BA BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Back surgery, Neuropathy, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether yoga can help veterans with chronic lower back pain manage their symptoms over the long term. Researchers aim to determine if adding coaching and text reminders to a standard yoga practice, known as Enhanced Yoga, can improve pain relief and quality of life for up to 18 months. Veterans who have experienced lower back pain for more than three months and rate their pain at least 4 out of 10 might be suitable candidates. Participants should not have practiced yoga more than three times in the last six months and must be willing to adhere to the program and complete assessments. As an unphased trial, this study offers veterans a unique opportunity to explore innovative pain management strategies and contribute to valuable research.

Do I need to stop my current medications for the trial?

The trial requires that you do not change your current pain treatment unless it's medically necessary. So, you can continue your current medications as long as they are for pain management and not changed during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that yoga is a safe and well-tolerated option for people with chronic low back pain (cLBP). Studies have found that a 12-week yoga program is both feasible and effective, with participants reporting no serious issues or side effects. Another study suggested that yoga can help reduce pain and improve mobility for those with cLBP. Therefore, for veterans with chronic low back pain, both regular and enhanced yoga practices appear to be safe choices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these yoga treatments for chronic lower back pain because they offer a unique approach by focusing on holistic, non-pharmaceutical methods. Unlike standard care options like medication or physical therapy, Enhanced Yoga combines traditional hatha yoga with additional coaching and text reminders to boost long-term adherence and effectiveness. This innovative approach not only aims to alleviate pain but also encourages sustained lifestyle changes, which can lead to more durable outcomes for those suffering from chronic pain. The potential for yoga, especially when enhanced, to provide relief without the side effects associated with medication is a promising development in pain management.

What evidence suggests that this trial's yoga treatments could be effective for chronic low back pain?

Research has shown that yoga can help manage long-term low back pain. One study found that practicing yoga for 12 weeks improved participants' back mobility and reduced their need for pain medication. Another study found that yoga strengthens back muscles, reduces pain, and improves flexibility and balance. Early results suggest these benefits can last for several months. In this trial, participants will be assigned to either Standard Yoga or Enhanced Yoga. Enhanced Yoga, which includes extra coaching and support, aims to extend these benefits over a longer period. ^{2 4 5 6 7}

Who Is on the Research Team?

Erik J. Groessl, PhD BA BS

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for Veterans experiencing chronic lower back pain. It's designed to see if yoga can help reduce their pain and improve their quality of life over the long term. Participants should be willing to engage in regular yoga sessions.

Inclusion Criteria

My pain level is 4 out of 10 or higher.

I have had chronic low back pain for over 3 months.

I am a veteran over 18 years old.

Exclusion Criteria

I have not had back surgery in the past year.

Positive Romberg test (with or without sensory neuropathy)

I do not have a serious illness like severe lung disease or a BMI over 40.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly in-person yoga sessions for 12 weeks

12 weeks

12 visits (in-person)

Enhanced Treatment

Participants in the enhanced yoga arm receive weekly behavioral coaching sessions from weeks 10-15 and ongoing text reminders

6 weeks

Follow-up

Participants are monitored for long-term yoga practice and health outcomes

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Yoga
• Standard Yoga

Trial Overview

The study is testing two types of yoga interventions: Standard Yoga and Enhanced Yoga, to determine which one might offer better long-term relief from chronic low back pain. The effectiveness will be measured at 12 and 18 months after starting.

How Is the Trial Designed?

Group I: Enhanced Yoga Experimental Treatment 1 Intervention

Hatha yoga designed for Veterans with chronic low back pain plus coaching and texts to enhance durability and long-term adherence to yoga.

Group II: Standard Yoga Active Control 1 Intervention

Hatha yoga designed for Veterans with chronic low back pain.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39485352/

Effectiveness of Virtual Yoga for Chronic Low Back Pain

At 12 weeks, yoga now participants reported 21.4 (95% CI, 5.2-37.6) absolute percentage points less use of any analgesic medication during the ...

2.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2825746

Effectiveness of Virtual Yoga for Chronic Low Back Pain

Findings of this study indicate that a 12-week therapeutic virtual yoga program for chronic low back pain is feasible, safe, and effective.

3.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1273473/full

Efficacy and safety of yoga for the management of chronic ...

It can improve the strength of the back muscles and alleviate pain while promoting the extension, flexibility, and balance of the body tissue of ...

4.

acpjournals.org

acpjournals.org/doi/10.7326/0003-4819-155-9-201111010-00003

Yoga for Chronic Low Back Pain: A Randomized Trial

Offering a 12-week yoga program to adults with chronic or recurrent low back pain led to greater improvements in back function than did usual care.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00865358

NCT00865358 | Yoga for Chronic Low Back Pain

We will assess the feasibility and collect preliminary data on yoga for chronic low back pain in predominantly minority individuals in a community health center ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11530940/

Effectiveness of Virtual Yoga for Chronic Low Back Pain

Findings of this study indicate that a 12-week therapeutic virtual yoga program for chronic low back pain is feasible, safe, and effective.

7.

bmjopensem.bmj.com

bmjopensem.bmj.com/content/11/2/e002697

Chronic low back pain management: clinical and ...

This study aims to compare the efficacy of Sphinx pose yoga and MBSR in managing CLBP. The focus is on evaluating improvements in pain intensity, functional ...