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

Chronic Pain Clinical Trial

— PT-IN-MIND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875207
• Other study ID #: 159762
• Secondary ID: 1R01AT012229-01
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: Jake Magel, PhD
• Phone: 801-581-4709
• Email: jake.magel[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Mindfulness based practice
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
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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	National Center for Complementary and Integrative Health (NCCIH), University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Aim #2: Physical therapist retention (competency assessment)	Percent of physical therapists who attend the competency assessment.	6 - 8 weeks after I-EPT live training
Secondary	Aim #2: Randomized physical therapists	Percentage of physical therapists invited who consent to be randomized	At recruitment
Secondary	Aim #2: Physical therapist enrollment	Percent of physical therapists presented the study who choose to enroll in the study	At recruitment
Secondary	Aim #3: Opioid MMEs on Timeline followback (TLFB)	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.	Baseline 6 and 12 weeks
Secondary	Aim 3: PEG (Pain, Enjoyment, General activity)	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	baseline, 6 and 12 weeks
Secondary	Aim #3 Patient Reported: Pain Catastrophizing Scale (PCS) short form	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.	baseline, 6 and 12 weeks
Secondary	Aim #3 Patient Reported: Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b (PROMIS-6b)	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	baseline, 6 and 12 weeks
Secondary	Aim #3 Patient Reported:Patient Reported Outcomes Measurement Information System (PROMIS)PROMIS Sleep Disturbance Short Form 6a	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	baseline, 6 and 12 weeks
Secondary	Aim #3 Patient Reported: Patient Health Questionnaire-2 (PHQ-2)	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	baseline, 6 and 12 weeks
Secondary	Aim #3 Patient Reported: Generalized Anxiety Disorder-2 (GAD-2)	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	baseline, 6 and 12 weeks
Secondary	Aim #3 Patient Reported: Patient Global Impression Scale-Change	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	6 and 12 weeks
Secondary	Aim #3 Patient Reported: Pain Self-Efficacy Questionnaire (PSEQ)	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	baseline, 6 and 12 weeks
Secondary	Aim #3 Patient Reported: Mindfulness-Five Facet Mindfulness Questionnaire (FFMQ)	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	baseline, 6 and 12 weeks
Secondary	Aim #3 Patient Reported: Positive Reappraisal Subscale of Cognitive Emotion Regulation Questionnaire (reappraisal subscale)	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.	baseline, 6 and 12 weeks
Secondary	Aim #3 Patient Reported: Savoring Beliefs Inventory	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.	baseline, 6 and 12 weeks
Secondary	Aim #3 Patient Reported: Participant-report health care utilization measures	Measure health care use (imaging,, tests, physician visits, medications)	4, 8 and 12 weeks
Secondary	Aim #3 Patient Reported: Short Assessment of Patient Satisfaction	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)	6 and 12 weeks
Secondary	Aim #3 Patient Reported: The Internal Pain Activity Questionnaire (IPAQ) short form measures physical activity	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.	Baseline, 6 and 12 weeks
Secondary	Aim #3 Reach: Patients offered and enrolled	The percentage of patients with chronic muscle condition and long-term opioid treatment offered participation who choose to enroll.	At recruitment
Secondary	Aim #3 Reach: Physical therapists with enrolled patients	The percentage of physical therapists who have a patient enrolled on their schedule	At recruitment
Secondary	Aim #3 Effectiveness: REDCap Outcomes Collected	The percentage of all patient reported outcome measures collected using REDCap	12 weeks
Secondary	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.	12 weeks
Secondary	Aim #3 Adoption: Mindfulness Oriented Recovery Enhancement component (MORE)	Percentage of patients enrolled after I-EPT training that report receiving any MORE component.	12 weeks
Secondary	Aim #3 Implementation: Fidelity	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.	12 weeks
Secondary	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)	12 weeks
Secondary	Aim #3: Adoption, Maintenance and Implementation: Qualitative Interviews	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	12 weeks
Secondary	Aim #3: Physical therapist retention	The percentage of physical therapists who participate in the fidelity assessments	12 weeks
Secondary	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
Secondary	Aim #3: Screened patients	Percentage of patients screened who are eligible	At recruitment
Secondary	Sleep duration	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.	baseline, 6 and 12 weeks
Secondary	Aim # 3: Adoption: Patient retention	Percentage of patients managed by study PTs who are retained at baseline, 6- and 12-week follow-up	baseline, 6 and 12 weeks.
Secondary	Aim # 3 implementation: Modified version of the Mindfulness Oriented Recovery Enhancement - Functional Measure during patient encounters.	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	12 weeks
Secondary	Aim #3: Adherence	THe number of recommended patient visits attended	12 weeks
Secondary	Aim # 3 Adherence	Number of minutes spent practicing mindfulness, reappraisal or savoring each day	weekly for 12 weeks
Secondary	Aim # 3 Adoption: Patients receiving MORE Components	Percentage of patients enrolled that report receiving any MORE component	12 weeks