PT-IN-MIND: study protocol for a multisite randomised feasibility trial investigating physical therapy with integrated mindfulness (PT-IN-MIND) for patients with chronic musculoskeletal pain and long-term opioid treatment who attend outpatient physical therapy.
Study Goal
The researchers aimed to evaluate the feasibility of a cluster randomized trial testing the effectiveness of integrating mindfulness-based interventions with evidence-based physical therapy (I-EPT) for managing chronic musculoskeletal pain in patients on long-term opioid treatment.
Results Summary
The study refined and manualized the I-EPT protocol, assessed different training intensities for physical therapists, and evaluated feasibility across implementation domains. Coprimary endpoints included pain and opioid use outcomes at 12 weeks, but specific efficacy results were not detailed in the abstract.
Population
Patients with chronic musculoskeletal pain receiving outpatient physical therapy and long-term opioid treatment.
Effective Dosage
Not specified
Duration
12 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
physical therapist-led mindfulness-based interventions integrated with evidence-based physical therapy (I-EPT) | null | the impact to manage patients with chronic musculoskeletal pain and long-term opioid treatment | patients with chronic musculoskeletal pain and long-term opioid treatment | null | has not been elucidated | #1 |
I-EPT treatment protocol | null | treatment protocol | patients and physical therapists | null | refine and manualise | #2 |
different intensities of physical therapist training programmes for the refined I-EPT treatment protocol | null | training programmes | physical therapists | null | evaluate | #3 |
competency in the provision of I-EPT | null | competency | LowIT and HighIT groups | null | assessed | #4 |
the refined I-EPT treatment protocol | null | treatment protocol | 90 patients managed by the randomised physical therapists | null | tested | #5 |
INTRODUCTION: Many individuals receiving outpatient physical therapy have musculoskeletal pain and up to one-third use prescription opioids. The impact of physical therapist-led mindfulness-based interventions integrated with evidence-based physical therapy (I-EPT) to manage patients with chronic musculoskeletal pain and long-term opioid treatment has not been elucidated. This project evaluates the feasibility of conducting a cluster randomised trial to test the effectiveness of I-EPT. METHODS AND ANALYSIS: Study 1 aim: Refine and manualise the I-EPT treatment protocol. Our approach will use semistructured interviews of patients and physical therapists to refine an I-EPT training manual. Study 2 aim: Evaluate different intensities of physical therapist training programmes for the refined I-EPT treatment protocol. Physical therapists will be randomised 1:1:1 to high-intensity training (HighIT), low-IT (LowIT) training and no training arms. Following training, competency in the provision of I-EPT (LowIT and HighIT groups) will be assessed using standardised patient simulations. Study 3 aim: Evaluate the feasibility of the I-EPT intervention across domains of the Reach, Effectiveness, Adoption, Implementation, Maintenance implementation framework. The refined I-EPT treatment protocol will be tested in two different health systems with 90 patients managed by the randomised physical therapists. The coprimary endpoints for study 3 are the proportions of the Pain, Enjoyment of Life and General Activity Scale and the Timeline Followback for opioid use/dose collected at 12 weeks. ETHICS AND DISSEMINATION: Ethics approval for the study was obtained from the University of Utah, University of Florida and Florida State University Institutional Review Boards. Informed consent is required for participant enrolment in all phases of this project. On completion, study data will be made available in compliance with NIH data sharing policies. TRIAL REGISTRATION NUMBER: NCT05875207.