Trial Summary
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.
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.
12345Is 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.
26789How 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.
1261011Eligibility 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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Yoga ArmExperimental Treatment1 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 armActive Control1 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:
πΊπΈ Approved in United States as Yoga therapy for:
- Chronic low back pain
- Stress relief
- Improvement in quality of life
πͺπΊ Approved in European Union as Medical Yoga Therapy for:
- Chronic low back pain
- Stress relief
- Improvement in quality of life
π¨π¦ Approved in Canada as Therapeutic yoga for:
- Chronic low back pain
- Stress relief
- Improvement in quality of life
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NYULangoneNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
References
Yoga Treatment for Chronic Non-Specific Low Back Pain (2017). [2019]Wieland LS, Skoetz N, Pilkington K, Vempati R, DΧ³Adamo CR, Berman BM. Yoga treatment for chronic non-specific low back pain.Cochrane Database Syst Rev2017, Issue 1. Art. No.: CD010671. DOI: 10.1002/14651858.CD010671.pub2.
A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: trial protocol. [2021]A systematic review revealed three small randomised controlled trials of yoga for low back pain, all of which showed effects on back pain that favoured the yoga group. To build on these studies a larger trial, with longer term follow-up, and a number of different yoga teachers delivering the intervention is required. This study protocol describes the details of a randomised controlled trial (RCT) to determine the effectiveness and cost-effectiveness of Yoga for chronic Low Back Pain, which is funded by Arthritis Research Campaign (arc) and is being conducted by the University of York. 262 patients will be recruited from GP practices in 5 centres in England. Patients will be randomised to receive usual care or 12 weekly classes of yoga. A yoga programme will be devised that can be delivered by yoga teachers of the two main national yoga organisations in the UK (British Wheel of Yoga and Iyengar Yoga Association (UK)).
Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans. [2021]Yoga interventions can improve function and reduce pain in persons with chronic low back pain (cLBP).
A randomised controlled trial of yoga for the treatment of chronic low back pain: results of a pilot study. [2022]To conduct a pilot trial of yoga for the treatment of chronic low back pain (LBP) to inform the feasibility and practicality of conducting a full-scale trial in the UK; and to assess the efficacy of yoga for the treatment of chronic low back pain.
The Effects of Yoga and Stabilization Exercises in Patients With Chronic Low Back Pain: A Randomized Crossover Study. [2023]This study aimed to assess the effectiveness of yoga and stabilization exercises in patients with chronic low back pain. Thirty-five female patients were randomly assigned to the stabilization exercise group or the yoga group. Outcome measures were the visual analog scale (VAS), Oswestry Disability Index (ODI) and Back Performance Scale (BPS), 6-minute walk test (6MWT), Fear-Avoidance Beliefs Questionnaire (FABQ), and Pittsburgh Sleep Quality Index (PSQI). The scores of the VAS, ODI, BPS, 6MWT, and PSQI improved significantly after both interventions (P .05). Both exercise approaches were found to be similarly effective on pain, function, metabolic capacity, and sleep quality.
Effect of yoga on quality of life of CLBP patients: A randomized control study. [2022]In two of the earlier Randomized Control Trials on yoga for chronic lower back pain (CLBP), 12 to 16 weeks of intervention were found effective in reducing pain and disability.
The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]As yoga has gained popularity as a therapeutic intervention, its safety has been questioned in the lay press. Thus, this review aimed to systematically assess and meta-analyze the frequency of adverse events in randomized controlled trials of yoga. MEDLINE/PubMed, Scopus, the Cochrane Library, and IndMED were screened through February 2014. Of 301 identified randomized controlled trials of yoga, 94 (1975-2014; total of 8,430 participants) reported on adverse events. Life-threatening, disabling adverse events or those requiring intensive treatment were defined as serious and all other events as nonserious. No differences in the frequency of intervention-related, nonserious, or serious adverse events and of dropouts due to adverse events were found when comparing yoga with usual care or exercise. Compared with psychological or educational interventions (e.g., health education), more intervention-related adverse events (odds ratio = 4.21, 95% confidence interval: 1.01, 17.67; P = 0.05) and more nonserious adverse events (odds ratio = 7.30, 95% confidence interval: 1.91, 27.92; P
[Where and How does Yoga Work? - A Scientific Overview]. [2017]As a traditional health care system, yoga combines physical activity, breathing techniques and meditation. It is increasingly used as a preventive or therapeutic means. Yoga has been researched in hundreds of randomized controlled trials. Positive effects are especially found for chronic pain conditions, hypertension, depression and in supportive cancer care. While there are case reports of serious adverse events associated with yoga, the risk seems to be extremely low and comparable to other forms of physical activity. Yoga can thus be considered as a safe and effective adjunct therapy for a number of conditions.
A large-scale survey of adverse events experienced in yoga classes. [2022]Yoga is a representative mind-body therapy of complementary and alternative medicine. In Japan, yoga is practiced widely to promote health, but yoga-associated adverse events have also been reported. To date, the frequencies and characteristics of yoga-related adverse events have not been elucidated. This study was conducted to elucidate the frequencies and characteristics of adverse events of yoga performed in classes and the risk factors of such events.
A comprehensive yoga programs improves pain, anxiety and depression in chronic low back pain patients more than exercise: an RCT. [2022]Previously, outpatient Yoga programs for patients with chronic low back pain (CLBP) lasting several months have been found to reduce pain, analgesic requirement and disability, and improve spinal mobility. This study evaluated changes in pain, anxiety, depression and spinal mobility for CLBP patients on short-term, residential Yoga and physical exercise programs, including comprehensive yoga lifestyle modifications.
Effectiveness of Hatha Yoga Versus Conventional Therapeutic Exercises for Chronic Nonspecific Low-Back Pain. [2020]Objective: To determine whether the effectiveness of Hatha yoga therapy is comparable to conventional therapeutic exercises (CTEs) for reducing back pain intensity and back-related dysfunction in patients with chronic nonspecific low-back pain (CNLBP). Design: The study was a prospective randomized comparative trial, divided into two phases: an initial 6-weekly supervised intervention period followed by a 6-week follow-up period. Settings: This study was conducted at Department of Physical Medicine and Rehabilitation and Centre for Integrative Medicine and Research of a tertiary care hospital. Subjects: Patients between 18 and 55 years of age with complaint of CNLBP persisting ≥12 weeks with pain rating ≥4 on a numerical rating scale (0-10). Intervention: A total of six standardized 35-min weekly Hatha yoga sessions (yoga group) and similarly 35-min weekly sessions of CTEs (CTE group), designed for people with CNLBP unaccustomed to structured yoga or CTE program. Participants were asked to practice on nonclass days at home. Outcome measures: The primary outcome measures were Defense and Veterans Pain Rating Scale (DVPRS) (0-10) and 24-point Roland Morris Disability Questionnaire (RDQ). Secondary outcomes were pain medication usage per week and a postintervention Perceived recovery (Likert seven-point scale) of back-related dysfunction. Outcomes were recorded at the baseline, 6-week follow-up, and 12-week follow-up. Results: Seventy subjects were randomized to either yoga (n = 35) or CTE group (n = 35). Data were analyzed using intention-to-treat, with last observation carried forward. Both yoga and the CTE group have shown significant improvement in back pain intensity and back-related dysfunction within both the groups at 6- and 12-week follow-ups compared to baseline. No statistically significant differences in the pain intensity (DVPRS; at 6 weeks: n = 35, difference of medians 1.0, 95% confidence interval [-5.3 to 3.0], p = 0.5; at 12 weeks: n = 35, 0.0 [-4.2 to 5.0], 0.7) and back-related dysfunction (RDQ; at 6 weeks: n = 35, 1.0 [-9.6 to 10.6], 0.4; at 12 weeks: n = 35, 0.0 [-8.8 to 10.6], 0.3) were noted between two groups. Improvements in pill consumption and perceived recovery were also comparable between the groups. Conclusion: Yoga provided similar improvement compared with CTEs, in patients with CNLBP.