PROJECT SUMMARY/ABSTRACT
An estimated 20%–30% of persons with chronic musculoskeletal pain (CMP) use opioids for pain
management. In recent years, the prevalence of long-term opioid treatment (LTOT) has increased in patients
with musculoskeletal pain. Particularly concerning are the significant LTOT-related risks (e.g., opioid-related
abuse, overdose, and death). Physical therapy (PT) is a common nonpharmacologic management strategy
recommended for CMP. The majority of patients in outpatient PT clinics have musculoskeletal pain, and at
least one in three use prescription opioids. Combining exercise-based interventions with mindfulness practices
is effective for patients with CMP, and engaging in mindfulness practices leads to a reduction in opioid dose in
patients with chronic pain and LTOT. However, the impact of physical therapist-led mindfulness-based
interventions integrated with evidence-based PT (I-EPT) to manage patients with CMP and LTOT has not been
elucidated. Our overall goal is to develop effective, scalable strategies to manage patients with CMP and LTOT
in the PT setting. In response to the FOA PAR-21-241 for multisite feasibility clinical trials of mind and body
interventions, this proposal focuses on evaluating the feasibility of conducting a fully-powered clinical trial that
tests I-EPT. In preparation for a fully-powered trial, we propose a before and after multi-site feasibility clinical
trial conducted in PT clinics located in an academic health care system in the Intermountain West and PT
clinics that are part of a rehabilitation system in the Southeast. We will evaluate the feasibility of providing I-
EPT to patients with CMP and LTOT by carrying 3 Specific Aims. Aim 1: Refine and manualize the I-EPT
treatment protocol for patients with CMP and LTOT. Our approach will use semi-structured interviews of
patients and physical therapists to refine I-EPT. Using the results of the semi-structured interviews, we will
manualize the I-EPT treatment protocol. Aim 2: Evaluate different intensities of a physical therapist training
programs for the refined I-EPT treatment protocol. Our approach will be to randomize physical therapists 2:1 to
training and no training groups. The training group will include a high intensity training (HighIT) program and a
low intensity training program (LowIT). Following the training programs, we will examine immediate post-
training competency in providing I-EPT using a standardized patient simulation. Aim 3: Evaluate the feasibility
of the I-EPT intervention across domains of the RE-AIM framework. Our approach will be to pilot test the
refined I-EPT treatment protocol in patients managed by physical therapists randomized to training and no
training arms. We will use mixed-methods to assess feasibility outcomes. The results of this feasibility study
will inform the design and execution of our planned fully powered clinical trial and could lead to improved
management of patients with CPM and LTOT.
