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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Behavioral: Mindfulness based practice
* Behavioral: Control/Standard Physical Therapy


Participation Criteria
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Eligibility Criteria
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Aim 1 Physical Therapist Inclusion Criteria: Employed at least .5 (Full Time Equivalent) Manages patients with musculoskeletal conditions Exclusion Criteria: None Aim 2 and 3 Physical Therapist Inclusion Criteria: Employed at least .5 (Full Time Equivalent) Manages patients with 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 pain. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a multi-site feasibility randomized clinical trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evidence based physical therapy combined with mindfulness (Low-Intensity)<br>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<br>* 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.<br>|
| Other: Standard physical therapy<br>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<br>* 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.<br>|
| Experimental: Evidence based physical therapy combined with mindfulness (High-Intensity)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) 21-item scale - total scores range from 0 - 114. Scores are summed and averaged. | 6 weeks | 
| Aim #2: Opioid Dose on Timeline followback | Patient reported opioid dose on the timeline followback | Change in opioid dose from baseline to 6 weeks | 
| Aim 3: PEG (Pain, Enjoyment, General activity) | The Pain, Enjoyment and General Active scale 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. | Change in PEG from baseline to 6 weeks | 
| Aim #3 Opioid Dose on Timeline followback | Patient reported opioid dose on the timeline followback | Change in opioid dose from baseline to 12 weeks | 
| Aim 3: PEG (Pain, Enjoyment, General Activity) | The Pain, Enjoyment and General Active scale 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. | Change in PEG from baseline to 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aim #1 Qualitative Interviews | 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. | 1 month | 
| Aim #2: Physical therapist retention (competency assessment) | Percent of physical therapists who attend the competency assessment. | 3 months | 
| Aim #2: Randomized physical therapists | Percentage of physical therapists invited who consent to be randomized | 6 months | 
| Aim #2: Physical therapist enrollment | Percent of physical therapists presented the study who choose to enroll in the study | 2 months | 
| Aim #3 Patient Reported: Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b (PROMIS-6b) | Reported as a T-Score with a mean of 50 and a SD of 10 | Change from baseline to 6 weeks and change from baseline to 12 weeks | 
| Aim #3 Patient Reported:Patient Reported Outcomes Measurement Information System (PROMIS)PROMIS Sleep Disturbance Short Form 6a | Reported as a T-Score with a mean = 50 and a SD = 10 | Change from baseline to 6 weeks and change from baseline to 12 weeks | 
| Aim #3 Patient Reported: Pain Catastrophizing Scale short form | Scores range 0- 24. Higher scores mean greater catastrophizing. | change from baseline to 6 weeks and change from baseline to 12 weeks | 
| Aim #3 Patient Reported: Patient Health Questionnaire-2 (PHQ-2) | Scores range from 0-6. Higher scores mean greater likelihood of depression | Changes on the Patient Health Questionnaire-2 (PHQ-2) questions from baseline to 6 weeks and from baseline to 12 weeks. | 
| Aim #3 Patient Reported: Generalized Anxiety Disorder-2 (GAD-2) | 2 items summed range 0 - 6. Higher score mean greater likelihood of anxiety | Changes on the Generalized Anxiety Disorder-2 (GAD-2) questions from baseline to 6 weeks and baseline to 12 weeks. | 
| Aim #3 Patient Reported: Patient Global Impression Scale-Change | Scores range from 0 - 7 with higher score equating to greater improvement in condition | Changes on the Patient Global Impression Scale-Change questions from baseline to 6 weeks and from baseline to 12 weeks. | 
| Aim #3 Patient Reported: Pain Self-Efficacy Questionnaire | Scores range from0 - 60 with higher scores indicating greater levels of confidence in dealing with pain | changes from baseline to 6 weeks and from baseline to 12 weeks | 
| Aim #3 Patient Reported: Mindfulness-Five Facet Mindfulness Questionnaire (FFMQ) | 15 items scores range from 15 - 75 higher scores indicate greater mindfulness | Change from baseline to 6 weeks and baseline to 12 weeks | 
| Aim #3 Patient Reported: Positive Reappraisal Subscale of Cognitive Emotion Regulation Questionnaire | 4 items each scored 1 - 5. Higher the score the more positive reappraisal. | change from baseline to 6 weeks and change from baseline to 12 weeks | 
| Aim #3 Patient Reported: Savoring Beliefs Inventory | 24 items. Composite scores are obtained by averaging the subscales after rescoring the negatively worded items. Higher scores equate to greater savoring. | Changes from baseline to 6 weeks and change from baseline to 12 weeks | 
| Aim #3 Patient Reported: Participant-report health care utilization measures | Measure health care use (imaging, physician visits, medications) | 12 weeks | 
| Aim #3 Patient Reported: Short Assessment of Patient Satisfaction | 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) | 12 weeks | 
| Aim #3 Patient Reported: The Internal Pain Activity Questionnaire (IPAQ) short form measures physical activity | 7 items. Measures metabolic equivalents (METS). Higher score in METS equates to greater activity. | Baseline | 
| Aim #3 Reach: Patients offered and enrolled | The percentage of patients with chronic muscle pain and long-term opioid treatment offered participation who choose to enroll. | 3 months | 
| Aim #3 Reach: Physical therapists with enrolled patients | The percentage of physical therapists who have a patient enrolled on their schedule | 3 months | 
| Aim #3 Effectiveness: REDCap Outcomes Collected | The percentage of outcomes collection using REDCap | 3 months | 
| Aim #3 Effectiveness: Timeline Follow Back | Percentage of Timeline Followback collected | 3 months | 
| Aim #3 Adoption: Qualitative interviews | 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. | 3 months | 
| Aim #3 Adoption: Mindfulness Oriented Recovery Enhancement component (MORE) | Percentage of patients enrolled after I-EPT training that report receiving any MORE component. | 3 months | 
| Aim #3 Implementation: Fidelity | Mindfulness Oriented Recovery Enhancement _functional measure (Modified MORE-FM) fidelity measure during patient encounters. 21-item scale - total scores range from 0 - 114. Scores are summed and averaged. | 3 months | 
| Aim #3 Implementation: Qualitative Interviews | 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. | 3 months | 
| Aim #3 Implementation: Percentage of patients managed by PT | The percentage of patients managed by a single trained physical therapist (don't cross over between physical therapists) | 3 months | 
| Aim #3: Maintenance: Qualitative Interviews | 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. These interviews will be used to understand potential barriers for future implementation of physical therapy integrated with mindfulness | 3 months | 
| Aim #3: Physical therapist retention | The percentage of physical therapists who participate in the fidelity assessments | 3 months | 
| Aim #3: Patient retention | Percentage of patients managed by study physical therapists who are retained at baseline, 6- and 12-week follow-up. | baseline, 6 weeks, 12 weeks | 
| Aim #3: Screened patients | Percentage of patients screened who are eligible | 6 months | 
| Sleep duration | hours and minutes of actual sleep during past month | 12 weeks |