Yoga + Physical Therapy for Chronic Back Pain and Opioid Addiction

Recruiting at 1 trial location

Overseen By Beth Hribar, MPP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Must be taking: Methadone, Buprenorphine

Disqualifiers: Severe disabling conditions, acute psychiatric, malignancy, others

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

Compensation: Varies

Number of Visits: 19

Duration: 12 weeks

345 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how yoga and physical therapy can assist people with chronic back pain who also struggle with opioid addiction. Participants will be divided into three groups: one will practice yoga, another will receive physical therapy, and the third will continue their usual treatment. The goal is to identify which approach most effectively reduces pain and opioid use. This trial suits individuals receiving treatment for opioid use disorder and experiencing chronic back pain that affects daily life. As an unphased trial, it offers participants a unique opportunity to explore alternative therapies that may enhance their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on a stable dose of methadone or buprenorphine for opioid use disorder for at least 14 days before joining.

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

Research has shown that physical therapy (PT) is generally a safe way to manage pain. A Gallup poll found that 68% of people consider PT very safe. Starting PT early has been linked to a 10% lower risk of long-term opioid use, suggesting it may help reduce dependence on these medications.

Yoga has also proven effective for managing chronic low back pain. It is often used to help with depression, anxiety, and stress, which are common in people with chronic pain. A small study found that a hatha yoga program was both feasible and acceptable for individuals dealing with chronic pain and opioid use.

Both PT and yoga appear well-tolerated and have positive effects on pain and stress, making them safe options for those considering joining a clinical trial for chronic back pain and opioid addiction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using yoga and physical therapy for treating chronic back pain and opioid addiction because they offer a holistic and non-pharmacological approach. Unlike conventional treatments that often rely on medications like opioids or NSAIDs, these interventions focus on physical and mental well-being. Yoga combines physical postures with mindfulness and breathing techniques, potentially reducing pain perception and improving mental health. Physical therapy, tailored through the Saper protocol, provides personalized exercises to enhance mobility and alleviate pain. This dual approach could reduce reliance on medications and address both physical and psychological aspects of chronic pain.

What evidence suggests that this trial's treatments could be effective for chronic back pain and opioid addiction?

Research has shown that physical therapy, which participants in this trial may receive, can reduce pain and improve movement in people with chronic pain. One study found that starting physical therapy early lowered the chance of long-term opioid use by about 10%. This finding suggests it might help people rely less on opioids by managing their pain better.

Meanwhile, studies have found that yoga, another treatment option in this trial, can greatly reduce back pain and increase flexibility. For those with chronic low back pain, yoga has been effective in improving pain and quality of life. Both yoga and physical therapy show promise in reducing pain and potentially decreasing the need for opioids. ^{1 2 6 7 8}

Who Is on the Research Team?

Shadi Nahvi, MD

Principal Investigator

Albert Einstein College of Medicine

Joanna Starrels, MD

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic back pain who are also receiving treatment for opioid use disorder at Montefiore OTP network. They must have moderate to severe pain and not have changed their medication dose recently. Participants should be able to understand English or Spanish, and haven't done yoga or physical therapy in the last 60 days.

Inclusion Criteria

I have chronic back pain with a moderate or higher pain level.

I can communicate effectively in English or Spanish.

I have been on stable methadone or buprenorphine for OUD treatment for at least 12 weeks.

Exclusion Criteria

You have practiced yoga or received physical therapy in the last 60 days.

You are currently experiencing severe mental health issues like extreme mood swings, active thoughts of harming yourself or others, or losing touch with reality.

My cancer is causing my current pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Initial assessments and randomization into one of three groups: onsite yoga, onsite physical therapy, or treatment as usual

1 week

1 visit (in-person)

Treatment

Participants receive 12 weeks of either onsite yoga, onsite physical therapy, or treatment as usual

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at months 1, 2, 3, 6, and 9

6 months

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Physical Therapy
• Treatment As Usual
• Yoga

Trial Overview

The study compares three approaches: yoga classes, physical therapy sessions, both provided onsite at opioid treatment programs, and the usual care without these additions. The goal is to see which method best improves pain management and reduces opioid use over a period of up to nine months.

How Is the Trial Designed?

Group I: Yoga Experimental Treatment 1 Intervention

Participants in the yoga group will receive a manualized intervention of 12 weekly, group-based, 60-minute yoga classes, and guided home practice.

Group II: Treatment As Usual Experimental Treatment 1 Intervention

Participants in the Treatment As Usual group will receive routine clinical care. This includes: 1) pain assessment using a 10-point scale, at OTP admission and annual physical exams. This is documented on a templated form in the OTP electronic health record, as well as whether pain is acute vs chronic pain, and a treatment plan (e.g., on-site care, outside primary care clinician, pain management referral). 2) clinical treatment of pain by participants' on-site or outside clinicians.

Group III: Physical Therapy Experimental Treatment 1 Intervention

Participants in the PT group will receive a manualized intervention of 12 weekly, individual, 60-minute PT sessions, with home practice, based on the Saper protocol.

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A pilot study involving 8 inpatients with opioid use disorder demonstrated that a specially designed yoga program was safe and feasible, potentially helping to reduce withdrawal symptoms and cravings associated with opioid use.

The yoga program was validated by experts and tailored for two phases: an acute symptomatic phase and a maintenance phase, indicating its adaptability for different stages of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development, Validation, and Feasibility Testing of a Yoga Module for Opioid Use Disorder. Bhargav, H., Vidyasagar, PD., Venugopal, S., et al.[2022]

A study involving 71 participants in an opioid treatment program found that yoga is an underutilized but acceptable pain coping strategy, with participants showing a willingness to try it, especially those with prior yoga experience.

Participants with chronic pain reported using various coping strategies, but yoga was not commonly among them, highlighting the need for further research to implement yoga programs in opioid treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Acceptability of Yoga Among Patients with and without Chronic Pain Enrolled in a Licensed Opioid Treatment Program. Ahmadi, E., Evans, C., Agin-Liebes, G., et al.[2023]

In a 9-month case study of a patient with opioid dependence syndrome, incorporating yoga into conventional treatment led to improved clinical symptoms and a reduced need for Buprenorphine, a common medication for opioid dependence.

The patient's plasma beta-endorphin levels increased significantly from 2.02 pmol/L to 6.51 pmol/L, suggesting that yoga may enhance the body's natural opioid production, potentially aiding in the management of opioid dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga as an Adjunct for Management of Opioid Dependence Syndrome: A Nine-Month Follow-Up Case Report. Varshney, P., Bhargav, H., Vidyasagar, PD., et al.[2021]

Yoga has been shown to significantly reduce pain intensity and related impairments in individuals with chronic low back pain, and it is also effective for chronic neck pain and certain headaches.

The efficacy and safety of yoga are comparable to other exercise interventions and individualized physical therapy, highlighting its potential as a valuable treatment option for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Yoga as an intervention for chronic pain]. Anheyer, D., Cramer, H.[2023]

A pilot study involving 26 participants with opioid use disorder showed that a 12-week yoga intervention significantly reduced perceived stress compared to standard medication-assisted treatment (MAT) alone.

While both groups experienced a decrease in perceived stress over time, the yoga group demonstrated a more pronounced effect, suggesting that yoga could be a beneficial adjunctive therapy for individuals in MAT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga as an Adjunctive Intervention to Medication-Assisted Treatment with Buprenorphine+Naloxone. Lander, L., Chiasson-Downs, K., Andrew, M., et al.[2022]

A 5-week online training course in therapeutic yoga (TY) significantly improved physical therapists' (PTs) readiness and confidence to integrate TY into their treatment practices, with 63.1% of participants completing the course.

Most PTs initially felt unprepared to prescribe TY, but after the training, there were notable increases in their understanding and perceived safety of using TY with patients, indicating the training's effectiveness and feasibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining Physical Therapists' Readiness for Integrating Yoga Therapeutics into Rehabilitation. Thompson, A., Huberty, J., Eckert, R., et al.[2020]

A pilot study involving 40 participants (20 on methadone and 20 on buprenorphine) showed that a hatha yoga program is feasible and acceptable for individuals with chronic pain receiving opioid agonist therapy, with good retention and high fidelity in teaching.

Participants in the yoga group experienced significant improvements in mood, anxiety, and pain levels, indicating that yoga may be an effective complementary therapy for managing chronic pain in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study assessing acceptability and feasibility of hatha yoga for chronic pain in people receiving opioid agonist therapy for opioid use disorder. Uebelacker, LA., Van Noppen, D., Tremont, G., et al.[2023]

A cohort of patients with chronic pain and substance use disorder showed significant improvements in depression, pain, and quality of life after participating in a comprehensive inpatient treatment program that included detoxification, qigong, and 12-step recovery support.

The most notable improvements were observed between the initial assessment and the second assessment at 30 days, indicating that this integrated approach may effectively address both chronic pain and substance use issues in patients who have not responded to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive treatment for patients with chronic pain in a 12-step based substance use disorder program. Przekop, P., Przekop, A., Haviland, MG., et al.[2019]

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