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Completed

NCT Number: NCT05875207

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

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.

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Key information

Conditions

Chronic Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Opioid Use Pain Pain, Musculoskeletal Pathological Conditions, Signs and Symptoms Physical Therapy Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

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About this study

Chronic musculoskeletal pain is a leading cause of years lived with disability world-wide and the costliest health condition in the United States. An estimated 20%-30% of persons with chronic musculoskeletal pain use opioids for pain management. In recent years, the prevalence of long-term opioid treatment (LTOT) has increased in patients with musculoskeletal pain. Physical therapy (PT) is a common nonpharmacologic treatment recommended for chronic musculoskeletal pain. Studies suggest PT for musculoskeletal pain may reduce the likelihood of initiating opioid therapy and may protect against LTOT, but the role of PT as part of a multi-modal strategy to manage patients with chronic musculoskeletal pain and LTOT has not been investigated. Combining exercise-based interventions with mindfulness practices is effective for patients with chronic musculoskeletal pain, and engaging in mindfulness practices leads to a reduction in opioid dose in patients with chronic pain and LTOT. This is a feasibility study that will assess effectiveness of physical therapists in managing patients with chronic musculoskeletal pain and LTOT using mindfulness practices. the results of an aim may result in changes to the procedures of a subsequent aim.

This study is organized into three Aims that will be conducted consecutively.

Aim #1: is to refine and manualize physical therapist-led mindfulness-based interventions integrated with evidence-based PT (I-EPT) for patients with chronic musculoskeletal pain and LTOT. Our approach will use semi-structured interviews of 15 patients and 15 physical therapists to refine I-EPT.

Aim #2: Evaluate different intensities of a physical therapist training programs for the refined I-EPT treatment protocol. Our approach will be to randomize 45 physical therapists to 1 of 3 training arms (no training; low-intensity training; high-intensity training).

Aim #3: Evaluate the feasibility of the I-EPT intervention across domains of the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. We anticipate 90 patient participants will be enrolled onto the schedules of the randomized physical therapists in Aim 2. Semi-structured qualitative interviews will be conducted. For these interviews there will be separate cohorts of 27 participants from Utah and 27 from Florida. Each cohort will contain approximately 8 physical therapists (4 each from the HIghIT and LowIT programs), 13 patients and 7 between support staff, and clinic managers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Aim 1

Physical Therapist Inclusion Criteria:

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

Exclusion criteria

None

Aim 2 and 3

Physical Therapist Inclusion Criteria:

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

Physical Therapist Exclusion Criteria:

  • -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

Patient Inclusion Criteria:

  • 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)

Patient Exclusion Criteria:

  • 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
  • Musculoskeletal pain condition related to a fracture or surgical procedure in the past 6 months.

Treatment and study plan

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.

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.

Primary outcomes

  1. Aim #2: Mindfulness Oriented Recovery Enhancement fidelity measure

    Time frame: 6 - 8 weeks after I-EPT live training

    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.

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

    Time frame: 12 weeks

    Percentage of TLFBs collected at 12 weeks

    The TLFB collects number of morphine milligram equivalents taken by the patient over the past 4 weeks

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

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Aim #1 Qualitative Interviews

    Time frame: 1 month

    Semi-structured qualitative interviews will be conducted with patients and physical therapists after they review a mindfulness treatment protocol. Analysis will generate qualitative themes that will be used to modify the treatment protocol in preparation for Aim #2.

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

    Time frame: 6 - 8 weeks after I-EPT live training

    Percent of physical therapists who attend the competency assessment.

  3. Aim #2: Randomized physical therapists

    Time frame: At recruitment

    Percentage of physical therapists invited who consent to be randomized

  4. Aim #2: Physical therapist enrollment

    Time frame: At recruitment

    Percent of physical therapists presented the study who choose to enroll in the study

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

    Time frame: Baseline 6 and 12 weeks

    The TLFB collects number of morphine milligram equivalents taken by the patient over the past 4 weeks

    We will calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.

  6. Aim 3: PEG (Pain, Enjoyment, General activity)

    Time frame: baseline, 6 and 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.

    We will calculate the change from baseline to 6 and from baseline to 12 weeks

  7. Aim #3 Patient Reported: Pain Catastrophizing Scale (PCS) short form

    Time frame: baseline, 6 and 12 weeks

    Percentage of PCS short form scores collected at baseline, 6 and 12 weeks

    We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.

    Scores range 0- 24. Higher scores mean greater catastrophizing.

  8. Aim #3 Patient Reported: Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b (PROMIS-6b)

    Time frame: baseline, 6 and 12 weeks

    Percentage of PROMIS-6Bs collected at baseline, 6 and 12 weeks

    We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.

    PROMIS-6b is reported as a T-Score with a mean of 50 and a SD of 10

  9. Aim #3 Patient Reported:Patient Reported Outcomes Measurement Information System (PROMIS)PROMIS Sleep Disturbance Short Form 6a

    Time frame: baseline, 6 and 12 weeks

    Percentage of PROMIS Sleep Disturbance Short Form 6As collected at baseline, 6 and 12 weeks

    We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.

    Reported as a T-Score with a mean = 50 and a SD = 10

  10. Aim #3 Patient Reported: Patient Health Questionnaire-2 (PHQ-2)

    Time frame: baseline, 6 and 12 weeks

    Percentage of PHQ-2 scores collected at baseline, 6 and 12 weeks

    We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.

    Scores range from 0-6. Higher scores mean greater likelihood of depression

  11. Aim #3 Patient Reported: Generalized Anxiety Disorder-2 (GAD-2)

    Time frame: baseline, 6 and 12 weeks

    Percentage of GAD-2s collected at baseline, 6 and 12 weeks

    We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.

    2 items summed range 0 - 6. Higher score mean greater likelihood of anxiety

  12. Aim #3 Patient Reported: Patient Global Impression Scale-Change

    Time frame: 6 and 12 weeks

    Percentage of Patient Global Impression Scale-Change scores collected at baseline, 6 and 12 weeks

    We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.

    Scores range from 0 - 7 with higher score equating to greater improvement in condition

  13. Aim #3 Patient Reported: Pain Self-Efficacy Questionnaire (PSEQ)

    Time frame: baseline, 6 and 12 weeks

    Feasibility: Percentage of PSEQ scores collected at baseline, 6 and 12 weeks

    We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.

    PSEQ scores range from0 - 60 with higher scores indicating greater levels of confidence in dealing with pain

  14. Aim #3 Patient Reported: Mindfulness-Five Facet Mindfulness Questionnaire (FFMQ)

    Time frame: baseline, 6 and 12 weeks

    Feasibility: Percentage of FFMQ scores collected at baseline, 6 and 12 weeks

    We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.

    FFMQ has15 items and scores range from 15 - 75 higher scores indicate greater mindfulness

  15. Aim #3 Patient Reported: Positive Reappraisal Subscale of Cognitive Emotion Regulation Questionnaire (reappraisal subscale)

    Time frame: baseline, 6 and 12 weeks

    Feasibility: Percentage of reappraisal subscale scores collected at baseline, 6 and 12 weeks

    We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.

    4 items each scored 1 - 5. Higher the score the more positive reappraisal.

  16. Aim #3 Patient Reported: Savoring Beliefs Inventory

    Time frame: baseline, 6 and 12 weeks

    Percentage of Savoring Beliefs Inventory scores collected at baseline, 6 and 12 weeks

    We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.

    24 items - Composite scores are obtained by averaging the subscales after rescoring the negatively worded items. Higher scores equate to greater savoring.

  17. Aim #3 Patient Reported: Participant-report health care utilization measures

    Time frame: 4, 8 and 12 weeks

    Measure health care use (imaging,, tests, physician visits, medications)

  18. Aim #3 Patient Reported: Short Assessment of Patient Satisfaction

    Time frame: 6 and 12 weeks

    Percentage of Short Assessment of Patient Satisfaction scores collected at 6 and 12 weeks.

    We will also calculate the scores at 6 and 12 weeks

    7 items. Each item scored 0 - 4 . Reverse score items 1, 3, 5 and 7. Sum scores. Range from 0 (extremely dissatisfied to 7 (extremely satisfied)

  19. Aim #3 Reach: Patients offered and enrolled

    Time frame: At recruitment

    The percentage of patients with chronic muscle condition and long-term opioid treatment offered participation who choose to enroll.

  20. Aim #3 Patient Reported: The International Pain Activity Questionnaire (IPAQ) short form measures physical activity

    Time frame: Baseline, 6 and 12 weeks

    Percentage of IPAQ scores collected at baseline, 6 and 12 weeks

    We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.

    7 items. Measures metabolic equivalents (METS). Higher score in METS equates to greater activity.

  21. Aim #3. Patient Reported: Working Alliance Inventory - Short Short Revised (WAI-SR) Client Version

    Time frame: 4, 8 and 12 weeks

    Percentage of WAI-SR scores collected at 4, 8 and 12 weeks

    We will also calculate the change from 4 to 8 weeks and the change from 4 to 12 weeks.

    12 items. Higher scores indicate better therapeutic alliance.

  22. Aim #3 Reach: Physical therapists with enrolled patients

    Time frame: At recruitment

    The percentage of physical therapists who have a patient enrolled on their schedule

  23. Aim #3 Effectiveness: REDCap Outcomes Collected

    Time frame: 12 weeks

    The percentage of all patient reported outcome measures collected using REDCap

  24. Aim #3 Adoption: Qualitative interviews

    Time frame: 12 weeks

    Semi-structured qualitative interviews will be conducted with patient, PT, support staff interviews regarding their lived experience integrating mindfulness and physical therapy. Analysis will generate qualitative themes that will be used to plan for a fully-powered trial.

  25. Aim #3 Adoption: Mindfulness Oriented Recovery Enhancement component (MORE)

    Time frame: 12 weeks

    Percentage of patients enrolled after I-EPT training that report receiving any MORE component.

  26. Aim #3 Implementation: Fidelity

    Time frame: 12 weeks

    Mindfulness Oriented Recovery Enhancement _functional measure (Modified MORE-FM) fidelity measure during patient encounters.

    The MORE FM will be completed by a rater which entails the reviewer listening to audio recordings of all patient encounters at the end of the 12 week patient management period.

    18-item scale - total scores range from 0 - 114. Scores are summed and averaged.

  27. Aim #3 Implementation: Percentage of patients managed by PT

    Time frame: 12 weeks

    The percentage of patients managed by a single trained physical therapist (don't cross over between physical therapists)

  28. Aim #3: Adoption, Maintenance and Implementation: Qualitative Interviews

    Time frame: 12 weeks

    Semi-structured qualitative interviews will be conducted with patient, PT, support staff, managers and clinic leadership interviews regarding their lived experience integrating mindfulness and physical therapy. These interviews will be used to understand potential barriers and facilitators for future adoption, implementation and maintenance of I-EPT

  29. Aim #3: Physical therapist retention

    Time frame: 12 weeks

    The percentage of physical therapists who participate in the fidelity assessments

  30. Aim #3: Patient retention

    Time frame: baseline, 6 weeks, 12 weeks

    Percentage of patients managed by study physical therapists who are retained at baseline, 6- and 12-week follow-up.

  31. Aim #3: Screened patients

    Time frame: At recruitment

    Percentage of patients screened who are eligible

  32. Sleep duration

    Time frame: baseline, 6 and 12 weeks

    hours and minutes of actual sleep during past month collected at baseline, 6 and 12 weeks

    We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.

  33. Aim # 3: Adoption: Patient retention

    Time frame: baseline, 6 and 12 weeks.

    Percentage of patients managed by study PTs who are retained at baseline, 6- and 12-week follow-up

  34. Aim # 3 implementation: Modified version of the Mindfulness Oriented Recovery Enhancement - Functional Measure during patient encounters.

    Time frame: 12 weeks

    18 items. Scores range from 0 to 216. Higher scores equate to greater fidelity.

    Percentage of PTs who score an average of 3 on fidelity assessments

  35. Aim #3: Adherence

    Time frame: 12 weeks

    THe number of recommended patient visits attended

  36. Aim # 3 Adherence

    Time frame: weekly for 12 weeks

    Number of minutes spent practicing mindfulness, reappraisal or savoring each day

  37. Aim # 3 Adoption: Patients receiving MORE Components

    Time frame: 12 weeks

    Percentage of patients enrolled that report receiving any MORE component

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • University of Florida

Registry information

Official study title

Physical Therapy Integrated With Mindfulness for Patients With Chronic Musculoskeletal Pain and Long-Term Opioid Treatment

Acronym: PT-IN-MIND

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 25, 2023
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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