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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

PT-IN-MIND Trial 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.Check my eligibility

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.See study design

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.

PT-IN-MIND Trial 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.

PT-IN-MIND Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aim #2: Mindfulness Oriented Recovery Enhancement fidelity measure

Aim #3 Opioid Dose on Timeline followback

Aim #3: Opioid Dose on Timeline followback

+2 more

Secondary outcome measures

Aim #1 Qualitative Interviews

Aim #2: Physical therapist enrollment

Aim #2: Physical therapist retention (competency assessment)

+28 more

PT-IN-MIND 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 / 1Eligibility criteria met

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Who is running the clinical trial?

University of UtahLead Sponsor

1,100 Previous Clinical Trials

1,778,856 Total Patients Enrolled

27 Trials studying Chronic Pain

4,488 Patients Enrolled for Chronic Pain

National Center for Complementary and Integrative Health (NCCIH)NIH

833 Previous Clinical Trials

669,408 Total Patients Enrolled

45 Trials studying Chronic Pain

17,964 Patients Enrolled for Chronic Pain

University of FloridaOTHER

1,341 Previous Clinical Trials

715,601 Total Patients Enrolled

13 Trials studying Chronic Pain

2,265 Patients Enrolled for Chronic Pain

Media Library

Control/Standard Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05875207 — N/A

Chronic Pain Research Study Groups: Evidence based physical therapy combined with mindfulness (Low-Intensity), Evidence based physical therapy combined with mindfulness (High-Intensity), Standard physical therapy

Chronic Pain Clinical Trial 2023: Control/Standard Physical Therapy Highlights & Side Effects. Trial Name: NCT05875207 — N/A

Control/Standard Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05875207 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this examination seeking participants aged 30 and over?

"This clinical trial is open to individuals who are of legal age and below 75 years old."

Answered by AI

Who is eligible to enrol in this medical study?

"To qualify for this clinical research, individuals must be between the ages of 18 and 75 and have experienced chronic pain. Approximately 45 participants are sought after in total."

Answered by AI

Is there an open window for enrollment in this research endeavor?

"Per the information stored on clinicaltrials.gov, this trial is no longer actively recruiting participants. It was initially posted in July 1st 2023 and last updated on May 15th of the same year. However, there are 595 other medical studies currently enrolling individuals into their trials."

Answered by AI

What is the purpose of this clinical experiment?

"This trial has a 6 week evaluation window and its primary objective is to measure the effect of opioid dose on timeline followback. Additionally, qualitative interviews are conducted with patients and physical therapists in order to modify treatment protocols for Aim #2 which looks at randomizing physical therapists and their subsequent enrollment rate into the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jake Magel 2023. "Physical Therapy Integrated With Mindfulness for Patients With Chronic Pain and Opioid Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05875207.