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

Trial Summary

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.

What data supports the effectiveness of the treatment Mindfulness-Based Physical Therapy for Chronic Pain?

Research suggests that mindfulness interventions can help improve pain, physical function, mood, and sleep in people with chronic pain. Studies show that combining mindfulness with physical therapy may enhance these benefits, especially for conditions like low back pain. ^{1 2 3 4 5}

Is mindfulness-based physical therapy safe for chronic pain?

The safety of mindfulness-based physical therapy for chronic pain is not well-documented, as adverse events were inconsistently reported in studies. More research is needed to better understand its safety profile. ^{2 3 6 7 8}

How does Control/Standard Physical Therapy differ from other treatments for chronic pain?

Control/Standard Physical Therapy focuses on physical exercises and techniques to improve movement and reduce pain, while other treatments like Mindfulness-Based Physical Therapy incorporate mindfulness practices to address both physical and psychological aspects of chronic pain, potentially offering a more holistic approach. ^{1 2 6 9 10}

What is the purpose of this trial?

This study will use multiple methods to assess the feasibility of conducting a fully powered multisite clinical trial to test the effectiveness of integrating mindfulness-based interventions into physical therapy for patients with chronic musculoskeletal pain and long-term opioid treatment. First, researchers will develop a manual for training physical therapists to provide mindfulness-based interventions to patients with chronic musculoskeletal pain and long-term opioid treatment. Next, the researchers will evaluate the competency of physical therapists to provided mindfulness-based interventions after being randomized to one of 3 different mindfulness training arms. Patients scheduled for physical therapy with the randomized physical therapists will be invited to enroll in the study. These patients will be asked to complete a variety of patient reported outcomes including self-reported average pain and the the amount of prescription opioid pain medication taken.

Research Team

Jake Magel, PhD

Principal Investigator

University of Utah

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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-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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. [2023]

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

Mindfulness Interventions in Physical Rehabilitation: A Scoping Review. [2018]

3. England 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. [2023]

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

Cognitive therapy, mindfulness-based stress reduction, and behavior therapy for the treatment of chronic pain: randomized controlled trial. [2022]

5. Switzerland 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. [2021]

6. Spain pubmed.ncbi.nlm.nih.gov

Differential efficacy between cognitive-behavioral therapy and mindfulness-based therapies for chronic pain: Systematic review. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Mindfulness for Chronic Low Back Pain: A Qualitative Analysis. [2020]

8. United States 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. [2020]

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

Remotely Delivered Psychologically Informed Mindful Movement Physical Therapy for Pain Care: A Framework for Operationalization. [2023]

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

The clinical use of mindfulness meditation for the self-regulation of chronic pain. [2022]