University of Utah
Jake Magel
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.
Chronic Pain
Pain, Musculoskeletal
Opioid Use
Physical Therapy
Mindfulness based practice
Control/Standard Physical Therapy
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 45 participants |
| Masking : | SINGLE |
| Masking Description : | Lead statistician is also masked |
| Primary Purpose : | HEALTH_SERVICES_RESEARCH |
| Official Title : | Physical Therapy Integrated With Mindfulness for Patients With Chronic Musculoskeletal Pain and Long-Term Opioid Treatment |
| Actual Study Start Date : | 2023-08-14 |
| Estimated Primary Completion Date : | 2025-08-30 |
| Estimated Study Completion Date : | 2025-11-30 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 75 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of Florida
Gainesville, Florida, United States, 32611
RECRUITING
University of Utah
Salt Lake City, Utah, United States, 84112