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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• Employed at least .50 FTE (Full Time Equivalent)

• Self Report managing patients with chronic musculoskeletal conditions

• 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

• 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.

Locations
United States
Florida
University of Florida
RECRUITING
Gainesville
Utah
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Jake Magel, PhD
jake.magel@hsc.utah.edu
801-581-4709
Backup
Priscilla Blosser, RN
priscilla.blosser@hsc.utah.edu
801-213-6117
Time Frame
Start Date: 2023-08-14
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 45
Treatments
Experimental: Evidence based physical therapy combined with mindfulness (Low-Intensity)
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.
Other: Standard physical therapy
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.
Experimental: Evidence based physical therapy combined with mindfulness (High-Intensity)
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Center for Complementary and Integrative Health (NCCIH), University of Florida
Leads: University of Utah

This content was sourced from clinicaltrials.gov

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