Yoga for Chronic Back Pain

Overseen By Erich Anderer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Cardiac, Pulmonary, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to ask the trial organizers for more details.

What data supports the effectiveness of the treatment Yoga for Chronic Back Pain?

Research shows that yoga can help reduce pain and improve function in people with chronic low back pain. Studies have found that yoga is effective in improving pain levels, physical function, and even sleep quality for those suffering from this condition. ^{1 2 3 4 5}

Is yoga safe for humans, especially for chronic back pain?

Yoga is generally considered safe for humans, with a very low risk of serious adverse events, similar to other forms of physical activity. While some nonserious adverse events have been reported, they are not more frequent than those associated with usual care or exercise. ^{2 6 7 8 9}

How does yoga treatment for chronic back pain differ from other treatments?

Yoga for chronic back pain is unique because it not only reduces pain and disability but also improves overall quality of life by addressing anxiety and depression, which are often associated with chronic pain. Unlike conventional exercises, yoga incorporates lifestyle modifications and mindfulness, offering a holistic approach to managing back pain. ^{1 2 6 10 11}

What is the purpose of this trial?

Chronic low back pain is notoriously difficult to treat and is a primary contributor to lost work days and excessive health expenditures, and whose treatment has, in part, contributed to the opioid crisis. Surgery is only an option in a minority of these patients, usually confined to those with structural instability. Yoga is an ancient modality whose benefits are currently being studied.

Research Team

Erich Anderer

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for individuals who have been experiencing chronic back pain for at least three months. Participants should be willing and able to follow the study procedures. It's not suitable for those needing surgery due to conditions like fractures or infections, or with heart, lung, or other health issues that make yoga practice unsafe.

Inclusion Criteria

I am willing and able to follow the study's procedures.

I have had back pain above my buttocks for at least 3 months.

Exclusion Criteria

I need surgery for a condition like a broken bone, infection, or spine issue.

I have health issues that prevent me from doing yoga.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week standardized yoga practice or usual care including physical therapy, NSAIDs, and epidural steroid injections

6 weeks

Baseline Visit, 6 weeks Visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 months Visit, 1 year Visit, 2 years Visit

Long-term Follow-up

Participants are assessed for long-term changes in health outcomes

2 years

1 year Visit, 2 years Visit

Treatment Details

Interventions

• Yoga program

Trial Overview The trial is exploring how a structured yoga program might help people manage chronic low back pain, which often leads to missed work days and can contribute to opioid use. The aim is to see if yoga can be an effective non-surgical treatment option.

Participant Groups

Group I: Yoga Arm Experimental Treatment 1 Intervention

The study arm will involve a yoga protocol devised by Eddie Stern - a renowned Ashtanga yoga practitioner, and can include NSAIDs.

Group II: Control arm Active Control 1 Intervention

The control arm will involve usual care - 6 weeks of physical therapy, NSAIDs, and epidural steroid injections

Yoga program is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Yoga therapy for:

• Chronic low back pain
• Stress relief
• Improvement in quality of life

Approved in European Union as Medical Yoga Therapy for:

• Chronic low back pain
• Stress relief
• Improvement in quality of life

Approved in Canada as Therapeutic yoga for:

• Chronic low back pain
• Stress relief
• Improvement in quality of life

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

Yoga may provide small to moderate improvements in back-related function for individuals with chronic non-specific low back pain, with low-certainty evidence showing benefits at three to four months and six months after starting yoga.

However, the risk of adverse events, such as increased back pain, was found to be higher in those practicing yoga compared to non-exercise controls, indicating a need for caution in its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga Treatment for Chronic Non-Specific Low Back Pain (2017). Whitehead, A., Gould Fogerite, S.[2019]

A systematic review of three small randomized controlled trials indicated that yoga may be beneficial for reducing low back pain, with all studies favoring the yoga group.

To further investigate this, a larger randomized controlled trial involving 262 patients will assess the effectiveness and cost-effectiveness of a 12-week yoga program compared to usual care, aiming to provide more robust evidence for yoga as a treatment for chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: trial protocol. Cox, H., Tilbrook, H., Aplin, J., et al.[2021]

A study involving 150 military veterans with chronic low back pain showed that yoga significantly improves function and reduces pain, with an incremental cost-effectiveness ratio of $4488 per quality-adjusted life year (QALY) from the healthcare organization's perspective.

Yoga not only provides health benefits but also results in cost savings, making it a dominant treatment option compared to usual care, with an 89% chance of being cost-effective at a willingness-to-pay threshold of $50,000.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans. Groessl, EJ., Liu, L., Richard, EL., et al.[2021]

In a pilot trial involving 20 participants with chronic low back pain, yoga was compared to usual care, revealing that while no significant overall differences in clinical outcomes were found, the yoga group reported significantly less pain on the Aberdeen back pain scale at four weeks.

The study highlighted challenges in recruitment and attendance, with only 0.28% of the GP practice population being randomized, suggesting that strategies to improve participation and class attendance will be essential for a larger trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of yoga for the treatment of chronic low back pain: results of a pilot study. Cox, H., Tilbrook, H., Aplin, J., et al.[2022]

In a study of 35 female patients with chronic low back pain, both yoga and stabilization exercises significantly improved pain levels, disability, and sleep quality, as measured by various scales (VAS, ODI, PSQI) after the interventions.

While both exercise methods were effective, the stabilization exercises showed greater improvement in transversus abdominis activation, indicating a potential advantage in core muscle engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Yoga and Stabilization Exercises in Patients With Chronic Low Back Pain: A Randomized Crossover Study. Ulger, O., Oz, M., Ozel Asliyuce, Y.[2023]

A week-long intensive yoga program significantly improved quality of life and spinal flexibility in patients with chronic lower back pain (CLBP) compared to traditional physical therapy, as shown by improvements in the WHOQOL Bref scores and straight leg raising tests.

The study involved 80 patients and found that higher baseline stress levels negatively correlated with quality of life, highlighting the potential of yoga to address both physical and psychological aspects of CLBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of yoga on quality of life of CLBP patients: A randomized control study. Tekur, P., Chametcha, S., Hongasandra, RN., et al.[2022]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

Yoga has been shown to have positive effects on various health conditions, particularly chronic pain, hypertension, depression, and supportive cancer care, based on numerous randomized controlled trials.

The risk of serious adverse events from practicing yoga is very low, making it a safe and effective complementary therapy alongside other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Where and How does Yoga Work? - A Scientific Overview]. Cramer, H.[2017]

In a study of 2508 yoga class attendees, about 27.8% reported experiencing adverse events, primarily mild musculoskeletal symptoms, indicating that while yoga is generally safe, some participants may face risks, especially those with chronic conditions.

Participants with chronic diseases, poor physical condition, or those who found the class stressful had a higher likelihood of experiencing adverse events, particularly severe ones in elderly individuals and those with chronic musculoskeletal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A large-scale survey of adverse events experienced in yoga classes. Matsushita, T., Oka, T.[2022]

A 7-day residential Yoga program significantly reduced pain levels in patients with chronic low back pain (CLBP) by 49%, compared to a 17.5% reduction in a control group receiving physical therapy, indicating greater efficacy of Yoga for pain management.

The Yoga group also experienced significant reductions in anxiety (20.4% decrease) and depression (47% decrease), along with a 50% improvement in spinal mobility, suggesting that Yoga not only alleviates pain but also enhances overall mental and physical well-being more effectively than traditional physiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive yoga programs improves pain, anxiety and depression in chronic low back pain patients more than exercise: an RCT. Tekur, P., Nagarathna, R., Chametcha, S., et al.[2022]

A study involving 70 patients with chronic nonspecific low-back pain found that both Hatha yoga therapy and conventional therapeutic exercises significantly reduced back pain intensity and dysfunction over a 12-week period, with no significant differences between the two methods.

Improvements in pain medication usage and perceived recovery were also similar for both groups, suggesting that Hatha yoga can be an effective alternative to conventional exercises for managing chronic back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Hatha Yoga Versus Conventional Therapeutic Exercises for Chronic Nonspecific Low-Back Pain. Neyaz, O., Sumila, L., Nanda, S., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Yoga Treatment for Chronic Non-Specific Low Back Pain (2017). [2019]

2. England pubmed.ncbi.nlm.nih.gov

A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: trial protocol. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of yoga for the treatment of chronic low back pain: results of a pilot study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Effects of Yoga and Stabilization Exercises in Patients With Chronic Low Back Pain: A Randomized Crossover Study. [2023]

6. India pubmed.ncbi.nlm.nih.gov

Effect of yoga on quality of life of CLBP patients: A randomized control study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

[Where and How does Yoga Work? - A Scientific Overview]. [2017]

9. England pubmed.ncbi.nlm.nih.gov

A large-scale survey of adverse events experienced in yoga classes. [2022]

10. Scotland pubmed.ncbi.nlm.nih.gov

A comprehensive yoga programs improves pain, anxiety and depression in chronic low back pain patients more than exercise: an RCT. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Hatha Yoga Versus Conventional Therapeutic Exercises for Chronic Nonspecific Low-Back Pain. [2020]