Mindfulness-Based Physical Therapy for Chronic Pain

(PT-IN-MIND Trial)

Recruiting at 1 trial location

Overseen By Jake Magel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Opioids

Disqualifiers: Pregnancy, Substance use treatment, 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: 6

Duration: 12 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of adding mindfulness techniques to physical therapy for individuals with long-term muscle or joint pain who use opioids. Participants are divided into three groups: one receives regular physical therapy, while the other two receive varying levels of mindfulness training alongside their therapy. The trial aims to determine if mindfulness can reduce pain and opioid use more effectively than standard therapy alone. Individuals with musculoskeletal pain for at least three months who have taken prescription opioids most days in the last 90 days may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to explore innovative pain management strategies beyond standard treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does mention that participants should have used prescription opioids for most of the last 90 days, so it seems you may continue your current opioid treatment.

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

Research has shown that combining mindfulness with physical therapy is generally safe for people with chronic pain. In studies, patients found these mindfulness techniques manageable, with no major reports of serious side effects.

One study found that mindfulness can help manage pain and may even reduce the misuse of prescription painkillers. This suggests the approach not only alleviates pain but also promotes safer medication use.

In this trial, physical therapists will receive training to incorporate mindfulness, which has been safely used in other studies. Overall, early research suggests that mindfulness-based physical therapy is a safe method for managing chronic pain in those on long-term opioid treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial exploring mindfulness-based physical therapy for chronic pain because it combines standard physical therapy with mindfulness techniques, which is not typical in current treatments. Unlike standard options that focus solely on physical rehabilitation, these experimental treatments integrate mindfulness practices like mindful reappraisal and savoring to potentially enhance pain management, especially for those on long-term opioid treatment. The trial is investigating both low-intensity and high-intensity approaches, with the high-intensity arm involving more extensive training for therapists, which could lead to better patient outcomes. This innovative approach could help reduce reliance on opioids and improve overall quality of life for individuals with chronic musculoskeletal pain.

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

Research has shown that adding mindfulness to physical therapy may help people with chronic pain and long-term opioid use. For instance, studies have found that a program called Mindfulness-Oriented Recovery Enhancement (MORE) can lower opioid misuse and ease chronic pain. In one study, patients using MORE reported better pain control and less need for opioids. Another study found that mindfulness improved overall wellbeing and mental health in people with chronic pain. This trial will test the effectiveness of combining mindfulness with physical therapy in two separate arms: one with low-intensity mindfulness integration and another with high-intensity mindfulness integration. These findings suggest that combining mindfulness with physical therapy might enhance treatment effectiveness for managing pain and reducing opioid use. ^{3 4 6 7 8}

Who Is on the Research Team?

Jake Magel, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-75 with chronic musculoskeletal pain involving the spine or joints, who have been using prescription opioids for most of the last 90 days. Physical therapists in the study must work with such patients and not have extensive prior mindfulness training.

Inclusion Criteria

I work part-time or more as a physical therapist and treat patients with musculoskeletal conditions.

Exclusion Criteria

I am a physical therapist trained in mindfulness for patient care.

I am not currently seeing a physical therapist.

You are currently pregnant, getting treatment for musculoskeletal pain from a healthcare provider, receiving treatment for substance use disorder, or have musculoskeletal pain from a recent fracture or surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Competency Assessment

Physical therapists receive training and are assessed for competency in delivering mindfulness-based interventions

6-8 weeks

Multiple sessions for training and assessment

Treatment

Patients receive physical therapy integrated with mindfulness interventions

12 weeks

Regular sessions with physical therapists

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up assessments at 6 and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control/Standard Physical Therapy
• Mindfulness based practice

Trial Overview The study tests if adding mindfulness practices to physical therapy helps people with long-term musculoskeletal pain who are also on opioid treatment. It involves training physical therapists in mindfulness techniques and measuring patient outcomes like pain levels and opioid use.

How Is the Trial Designed?

Group I: Standard physical therapy Experimental Treatment 1 Intervention

Physical therapists randomized to this arm will deliver routine treatment for someone with chronic musculoskeletal pain and long-term opioid treatment. Patients with chronic musculoskeletal pain and long-term opioid treatment who seek care from a physical therapist in this arm will be approached to participate in the study. If eligible and willing to participate in the study they will be asked questions about pain and opioid use before, during and after treatment. We plan on enrolling 2 patients for each physical therapist.

Group II: Evidence based physical therapy combined with mindfulness (Low-Intensity) Experimental Treatment 1 Intervention

Physical therapists randomized to this arm will receive a manual on how to integrate MORE; mindfulness, mindful reappraisal, and mindful savoring savoring into routine outpatient physical therapy for patients with chronic musculoskeletal pain and long-term opioid treatment. After 4 weeks to review the manual, the physical therapist's competency will be assessed during mock patient encounters using trained actors as standardized patients. Patients with chronic musculoskeletal pain and long-term opioid treatment who seek care from a physical therapist in this arm will be approached to participate in the study. If eligible and willing to participate in the study they will be asked questions about pain and opioid use before, and after treatment. We plan on enrolling 2 patients for each physical therapist.

Group III: Evidence based physical therapy combined with mindfulness (High-Intensity) Experimental Treatment 1 Intervention

Physical therapists randomized to this arm will receive 13 hours of training. The first 6 hours consists of prerecorded didactic lectures that the physical therapist can view on their own time. After viewing the lectures, participants will attend 6.25 hours of live experiential instruction to promote trainee competence in providing mindfulness, mindful reappraisal, and mindful savoring after which the participating physical therapist's competency will be assessed during mock patient encounters using trained actors as standardized patients. . Patients with chronic musculoskeletal pain and long-term opioid treatment who seek care from a physical therapist in this arm will be approached to participate in the study. If eligible and willing to participate in the study they will be asked questions about pain and opioid use before, and after treatment. We plan on enrolling 2 patients for each physical therapist.

Control/Standard Physical Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Physical Therapy for:

• Chronic musculoskeletal pain
• Rehabilitation after surgery
• General physical rehabilitation

Approved in European Union as Physiotherapy for:

• Chronic musculoskeletal pain
• Rehabilitation after surgery
• General physical rehabilitation

Approved in Canada as Physical Therapy for:

• Chronic musculoskeletal pain
• Rehabilitation after surgery
• General physical rehabilitation

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

The OPTIMIZE Study will evaluate the effectiveness of physical therapy (PT), cognitive behavioral therapy (CBT), and mindfulness-based approaches in treating chronic low back pain, enrolling 945 participants to compare outcomes like disability and pain intensity.

This study aims to determine the best treatment options and sequences for patients who do not see significant improvement after initial therapy, potentially guiding future nonoperative treatment strategies for low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain. Skolasky, RL., Wegener, ST., Aaron, RV., et al.[2023]

The pilot study involving 16 adults with persistent low back pain demonstrated that the Mindfulness Based Functional Therapy (MBFT) intervention is feasible to implement in a primary care setting, with high participant satisfaction (85%).

Preliminary results indicated improvements in pain catastrophizing, physical functioning, and depression, suggesting that MBFT may enhance both physical and emotional functioning, warranting further investigation through a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Functional Therapy: a preliminary open trial of an integrated model of care for people with persistent low back pain. Schütze, R., Slater, H., O'Sullivan, P., et al.[2021]

Mindfulness and meditation significantly help older adults (aged 65 and older) cope with chronic low back pain by reducing negative emotions like fear and changing their perspective on pain, as revealed through focus group discussions with 25 participants who completed an eight-week program.

Key themes identified include overcoming fear of pain, increased awareness of pain rather than focusing on it, and a shift in how significant they perceive their pain, suggesting that mindfulness can effectively alter the emotional and cognitive responses to chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness for Chronic Low Back Pain: A Qualitative Analysis. Luiggi-Hernandez, JG., Woo, J., Hamm, M., et al.[2020]

The Empower Veterans Program (EVP) Mindful Movement framework effectively combines mindfulness, motivational interviewing, and behavioral approaches to address the biopsychosocial needs of veterans with chronic pain, demonstrating positive patient-reported outcomes before the COVID-19 crisis.

Since transitioning to remote delivery in 2020, the TelePain EVP has maintained engagement with multiple weekly group sessions, emphasizing interoceptive skills and self-efficacy, which can serve as a model for other programs aiming to implement psychologically informed physical therapy for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remotely Delivered Psychologically Informed Mindful Movement Physical Therapy for Pain Care: A Framework for Operationalization. Sullivan, MB., Hill, K., Ballengee, LA., et al.[2023]

A 10-week mindfulness meditation program for 90 chronic pain patients led to significant reductions in pain perception, mood disturbances, and psychological symptoms like anxiety and depression, along with increased self-esteem and activity levels.

Improvements were maintained for up to 15 months after training, indicating the long-term benefits of mindfulness meditation, while a comparison group receiving traditional treatments showed no significant improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical use of mindfulness meditation for the self-regulation of chronic pain. Kabat-Zinn, J., Lipworth, L., Burney, R.[2022]

This systematic scoping review analyzed 40 randomized controlled trials involving 2978 participants to explore the interactions between mindfulness-based interventions (MBIs) and concomitant analgesic drug therapies (CADTs) for chronic pain, revealing that while most trials allowed CADTs, very few provided details or controlled for their effects.

None of the trials examined how MBIs and CADTs interact, whether they work better together, or if one might hinder the other, highlighting a significant gap in research that needs to be addressed to understand the safety and efficacy of combining these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic scoping review of interactions between analgesic drug therapy and mindfulness-based interventions for chronic pain in adults: current evidence and future directions. Park, R., Mohiuddin, M., Poulin, PA., et al.[2020]

Mindfulness-based stress reduction (MBSR) was found to be more effective than usual care in managing symptoms and impact in fibromyalgia and low back pain, indicating its potential as a beneficial treatment option for chronic pain.

While MBSR showed superiority over usual care for various chronic pain conditions, there was no clear evidence that it was more effective than cognitive-behavioral therapy (CBT), suggesting that both interventions may be valuable but require further research to determine their comparative efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential efficacy between cognitive-behavioral therapy and mindfulness-based therapies for chronic pain: Systematic review. Pardos-Gascón, EM., Narambuena, L., Leal-Costa, C., et al.[2020]

A systematic review of 15 randomized controlled trials involving 1,199 patients found inconclusive evidence for mindfulness skills training (MST) improving self-reported physical function in chronic pain, highlighting variability in how physical function was measured.

Strong evidence indicated that MST did not lead to improvements in physical function when assessed through performance-based measures, suggesting a need for standardized assessment methods in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. Jackson, W., Zale, EL., Berman, SJ., et al.[2023]

Mindfulness interventions appear beneficial for patients with musculoskeletal and chronic pain disorders, and show potential for improving outcomes in neurocognitive and neuromotor disorders, based on a review of 16 studies.

Only a few studies involved occupational therapists as primary providers of mindfulness, highlighting a gap in higher-level research needed to establish effective practices for integrating mindfulness into occupational therapy in physical rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Interventions in Physical Rehabilitation: A Scoping Review. Hardison, ME., Roll, SC.[2018]

In a study involving 521 participants with chronic low back pain, cognitive therapy (CT), mindfulness-based stress reduction (MBSR), and behavior therapy (BT) all showed similar effectiveness in reducing pain and improving physical function, mood, and sleep disturbance compared to treatment as usual (TAU).

All three active treatments demonstrated significant improvements by the sixth session, suggesting that the specific techniques used may be less critical than the overall engagement in these evidence-based therapies for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive therapy, mindfulness-based stress reduction, and behavior therapy for the treatment of chronic pain: randomized controlled trial. Burns, JW., Jensen, MP., Thorn, B., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4076008/

Mindfulness-Oriented Recovery Enhancement for Chronic ... Findings demonstrate preliminary feasibility and efficacy of MORE as a treatment for co-occurring prescription opioid misuse and chronic pain.

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2789279

Mindfulness-Oriented Recovery Enhancement vs ... In this study, MORE appeared to be an efficacious treatment for opioid misuse among adults with chronic pain.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10948133/

Virtually delivered Mindfulness-Oriented Recovery ... The objective of this randomized controlled trial was to evaluate the impact of virtually delivered Mindfulness-Oriented Recovery Enhancement (MORE) on ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02602535

Study Details | NCT02602535 | Mindfulness-Oriented ... The central aim of this study is to test the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE), an intervention designed to disrupt the risk chain.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2451865422000795

Protocol for mindfulness-oriented recovery enhancement ... We hypothesize that MORE will be effective in improving self-reported pain, physical function, quality of life, depression symptoms, mindfulness, and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05875207

Physical Therapy Integrated With Mindfulness for Patients ... Combining exercise-based interventions with mindfulness practices is effective for patients with chronic musculoskeletal pain, and engaging in mindfulness ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10403309/

The Effectiveness of a Mindfulness-Based Intervention ... This study (MIND-PT) is a multisite randomized trial that compares an enriched pain management (EPM) pathway that integrates physical therapy and mindfulness.

8. bmjopen.bmj.com bmjopen.bmj.com/content/14/7/e082611

PT-IN-MIND: study protocol for a multisite randomised ... Mindfulness-oriented recovery enhancement for chronic pain and prescription opioid misuse: results from an early-stage randomized controlled trial. J ...