Clinical trial NCT05875207: Physical Therapy Integrated With Mindfulness for Patients With Chronic Pain and Opioid Treatment
Official title: Physical Therapy Integrated With Mindfulness for Patients With Chronic Musculoskeletal Pain and Long-Term Opioid Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Pain, Musculoskeletal
Opioid Use
Physical Therapy
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: University of Florida
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-05-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multi-site feasibility randomized clinical trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Aim #2: Mindfulness Oriented Recovery Enhancement fidelity measure
timeFrame: 6 - 8 weeks after I-EPT live training
measure: Aim #3: Opioid MMEs on Timeline followback (TLFB)
timeFrame: 12 weeks
measure: Aim 3: PEG (Pain, Enjoyment, General activity)
timeFrame: 12 weeks
Secondary outcomes:
measure: Aim #1 Qualitative Interviews
timeFrame: 1 month
measure: Aim #2: Physical therapist retention (competency assessment)
timeFrame: 6 - 8 weeks after I-EPT live training
measure: Aim #2: Randomized physical therapists
timeFrame: At recruitment
measure: Aim #2: Physical therapist enrollment
timeFrame: At recruitment
measure: Aim #3: Opioid MMEs on Timeline followback (TLFB)
timeFrame: Baseline 6 and 12 weeks
measure: Aim 3: PEG (Pain, Enjoyment, General activity)
timeFrame: baseline, 6 and 12 weeks
measure: Aim #3 Patient Reported: Pain Catastrophizing Scale (PCS) short form
timeFrame: baseline, 6 and 12 weeks
measure: Aim #3 Patient Reported: Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b (PROMIS-6b)
timeFrame: baseline, 6 and 12 weeks
measure: Aim #3 Patient Reported:Patient Reported Outcomes Measurement Information System (PROMIS)PROMIS Sleep Disturbance Short Form 6a
timeFrame: baseline, 6 and 12 weeks
measure: Aim #3 Patient Reported: Patient Health Questionnaire-2 (PHQ-2)
timeFrame: baseline, 6 and 12 weeks
measure: Aim #3 Patient Reported: Generalized Anxiety Disorder-2 (GAD-2)
timeFrame: baseline, 6 and 12 weeks
measure: Aim #3 Patient Reported: Patient Global Impression Scale-Change
timeFrame: 6 and 12 weeks
measure: Aim #3 Patient Reported: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: baseline, 6 and 12 weeks
measure: Aim #3 Patient Reported: Mindfulness-Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: baseline, 6 and 12 weeks
measure: Aim #3 Patient Reported: Positive Reappraisal Subscale of Cognitive Emotion Regulation Questionnaire (reappraisal subscale)
timeFrame: baseline, 6 and 12 weeks
measure: Aim #3 Patient Reported: Savoring Beliefs Inventory
timeFrame: baseline, 6 and 12 weeks
measure: Aim #3 Patient Reported: Participant-report health care utilization measures
timeFrame: 4, 8 and 12 weeks
measure: Aim #3 Patient Reported: Short Assessment of Patient Satisfaction
timeFrame: 6 and 12 weeks
measure: Aim #3 Reach: Patients offered and enrolled
timeFrame: At recruitment
measure: Aim #3 Patient Reported: The International Pain Activity Questionnaire (IPAQ) short form measures physical activity
timeFrame: Baseline, 6 and 12 weeks
measure: Aim #3. Patient Reported: Working Alliance Inventory - Short Short Revised (WAI-SR) Client Version
timeFrame: 4, 8 and 12 weeks
measure: Aim #3 Reach: Physical therapists with enrolled patients
timeFrame: At recruitment
measure: Aim #3 Effectiveness: REDCap Outcomes Collected
timeFrame: 12 weeks
measure: Aim #3 Adoption: Qualitative interviews
timeFrame: 12 weeks
measure: Aim #3 Adoption: Mindfulness Oriented Recovery Enhancement component (MORE)
timeFrame: 12 weeks
measure: Aim #3 Implementation: Fidelity
timeFrame: 12 weeks
measure: Aim #3 Implementation: Percentage of patients managed by PT
timeFrame: 12 weeks
measure: Aim #3: Adoption, Maintenance and Implementation: Qualitative Interviews
timeFrame: 12 weeks
measure: Aim #3: Physical therapist retention
timeFrame: 12 weeks
measure: Aim #3: Patient retention
timeFrame: baseline, 6 weeks, 12 weeks
measure: Aim #3: Screened patients
timeFrame: At recruitment
measure: Sleep duration
timeFrame: baseline, 6 and 12 weeks
measure: Aim # 3: Adoption: Patient retention
timeFrame: baseline, 6 and 12 weeks.
measure: Aim # 3 implementation: Modified version of the Mindfulness Oriented Recovery Enhancement - Functional Measure during patient encounters.
timeFrame: 12 weeks
measure: Aim #3: Adherence
timeFrame: 12 weeks
measure: Aim # 3 Adherence
timeFrame: weekly for 12 weeks
measure: Aim # 3 Adoption: Patients receiving MORE Components
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Jake Magel, PhD
role: PRINCIPAL_INVESTIGATOR
References: