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Mindfulness-Based Physical Therapy for Chronic Pain (PT-IN-MIND Trial)

N/A

Recruiting

Led By Jake Magel, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient: 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)

Be older than 18 years old

Must not have

Physical Therapist: None

Patient: 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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess the feasibility of using mindfulness-based interventions in physical therapy to help patients with chronic pain and long-term opioid treatment.

Who is the study for?

This trial is for English-speaking adults aged 18-75 with chronic musculoskeletal pain involving the spine or joints, who have been using prescription opioids for most of the last 90 days. Physical therapists in the study must work with such patients and not have extensive prior mindfulness training.

What is being tested?

The study tests if adding mindfulness practices to physical therapy helps people with long-term musculoskeletal pain who are also on opioid treatment. It involves training physical therapists in mindfulness techniques and measuring patient outcomes like pain levels and opioid use.

What are the potential side effects?

While specific side effects aren't listed, typical risks may include discomfort during exercise from physical therapy or emotional distress from confronting painful experiences during mindfulness practice.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18-75, speak English, have had musculoskeletal pain for over 3 months, and have been using prescription opioids.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not currently seeing a physical therapist.

Select...

You are currently pregnant, getting treatment for musculoskeletal pain from a healthcare provider, receiving treatment for substance use disorder, or have musculoskeletal pain from a recent fracture or surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aim #2: Mindfulness Oriented Recovery Enhancement fidelity measure

Secondary study objectives

Aim # 3 Adherence

Aim # 3 Adoption: Patients receiving MORE Components

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

+34 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Standard physical therapyExperimental Treatment1 Intervention

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.

Group II: Evidence based physical therapy combined with mindfulness (Low-Intensity)Experimental Treatment1 Intervention

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.

Group III: Evidence based physical therapy combined with mindfulness (High-Intensity)Experimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met