Physical Therapy Integrated With Mindfulness for Patients With Chronic Pain and Opioid Treatment

NCT05875207 | Completed DMC

• 2 other identifiers: 1597621R01AT012229-01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Pain; Pain, Musculoskeletal; Opioid Use; Physical Therapy

Outcome Measures

Primary Outcomes (3)

• Aim #2: Mindfulness Oriented Recovery Enhancement fidelity measure

  Mindfulness Oriented Recovery Enhancement fidelity (Modified MORE-FM) Version 2.0 measure score during post-training competency assessment of physical therapists (physical therapists randomized to High and Low Intensity training groups) 9 item scale - each item scored 0-6. Scores are summed and averaged.

  6 - 8 weeks after I-EPT live training

• Aim #3: Opioid MMEs on Timeline followback (TLFB)

  Percentage of TLFBs collected at 12 weeks The TLFB collects number of morphine milligram equivalents taken by the patient over the past 4 weeks

  12 weeks

• Aim 3: PEG (Pain, Enjoyment, General activity)

  Percentage of The Pain, Enjoyment and General Active (PEG) scales collected at 12 weeks The PEG measures pain intensity, enjoyment of life and general activity each on a 0 - 10 with higher scores indicating worse pain impact. The score is the average of all items.

  12 weeks

Secondary Outcomes (37)

• Aim #1 Qualitative Interviews

  1 month

• Aim #2: Physical therapist retention (competency assessment)

  6 - 8 weeks after I-EPT live training

• Aim #2: Randomized physical therapists

  At recruitment

• Aim #2: Physical therapist enrollment

  At recruitment

• Aim #3: Opioid MMEs on Timeline followback (TLFB)

  Baseline 6 and 12 weeks

Study Arms (3)

Evidence based physical therapy combined with mindfulness (Low-Intensity)

EXPERIMENTAL

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.

Behavioral: Mindfulness based practice

Standard physical therapy

OTHER

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.

Behavioral: Control/Standard Physical Therapy

Evidence based physical therapy combined with mindfulness (High-Intensity)

EXPERIMENTAL

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.

Behavioral: Mindfulness based practice

Interventions

Mindfulness based practice BEHAVIORAL

Physical therapists who are randomized to this arm will receive mindfulness training. This training will teach physical therapists to use the following with their patients: 1) use mindfulness to strengthen self-regulation of habitual and compulsive opioid use, and to mitigate pain by reinterpreting these experiences as innocuous sensory information, 2) use reappraisal to reframe stressors and maladaptive thoughts to decrease negative emotions and engender meaning in life, 3) use savoring of pleasant events and pleasurable sensations to enhance positive emotions and reward and, 4) to integrate mindfulness, reappraisal and savoring with evidence-based physical therapy.

Evidence based physical therapy combined with mindfulness (High-Intensity); Evidence based physical therapy combined with mindfulness (Low-Intensity)

Control/Standard Physical Therapy BEHAVIORAL

Physical therapists randomized to this arm will receive no additional training and will provide standard care to patients 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 their pain and opioid use before and after treatment. We plan on enrolling 2 patients for each physical therapist.

Standard physical therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Employed at least .50 FTE (Full Time Equivalent)
• Self Report managing patients with chronic musculoskeletal conditions

You may not qualify if:

• Aim 2 and 3
• Employed at least .50 FTE (Full Time Equivalent)
• Self Report managing patients with chronic musculoskeletal conditions
• Attended any experiential (i.e., practice sessions with real or simulated patients) mindfulness training to be used for patient care
• Attended any patient care specific mindfulness training lasting more than 3 hours.
• Self-report using mindfulness interventions such as savoring and cognitive reappraisal (core components of MORE) as a primary intervention strategy for the majority of their caseload for patients with chronic musculoskeletal conditions.
• Aims 1, 2 and 3
• Age 18-75
• English Speaking
• Diagnosis of musculoskeletal pain condition involving the spine and/or peripheral joint(s)
• Current musculoskeletal pain present for greater than or equal to 3 months.
• Use of prescription opioids for most of the last 90 days (self-report)
• Currently pregnant
• Currently receiving mind-body treatment for musculoskeletal pain from a healthcare provider (e.g. PT, chiropractic, massage therapy, etc)
• Currently receiving treatment for substance use disorder

Sponsors & Collaborators

• University of Utah: lead
• University of Florida: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

University of Florida

Gainesville, Florida, 32611, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Magel JS, Beneciuk JM, Siantz E, Fritz J, Garland EL, Hanley A, Shen J, Blosser P, Matev T, Gordon AJ. PT-IN-MIND: study protocol for a multisite randomised feasibility trial investigating physical therapy with integrated mindfulness (PT-IN-MIND) for patients with chronic musculoskeletal pain and long-term opioid treatment who attend outpatient physical therapy. BMJ Open. 2024 Jul 30;14(7):e082611. doi: 10.1136/bmjopen-2023-082611.

  PMID: 39079926 DERIVED

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Jake Magel, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Lead statistician is also masked
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a multi-site feasibility randomized clinical trial.

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 25, 2023
• Study Start: August 14, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 10, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Within 1 year after the completion of Aim 3
• Access Criteria: The IDSA will be subject to review by both the University of Utah and University of Florida legal and IRB departments. Outside researchers will be required to submit approval from their own IRB. Conditions placed on the use of the data include 1. No distribution to third parties 2. Proper acknowledgment and citation of the data providers and grant funding 3. Exclusive use by the data recipient in connection with a specific research project 4. Data recipient will maintain ultimate responsibility for the data received 5. Agreement not to use the data in any effort to establish the identity of participants 6. Data recipient will be subject to applicable federal, state, and local laws or regulations and institutional policies providing additional protections for human subjects

Locations

US (2)