Clinical trial NCT06077526: Alleviating Burden of Chronic Musculoskeletal Pain in the Emergency Department
Official title: Alleviating Burden of Chronic Musculoskeletal Pain in the Emergency Department: P.E.A.K. Rx Feasibility Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: musculoskeletal
Lead sponsor: Bridgewater College
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Upon recruitment and completion of informed consent, participants will be randomly assigned following a stratified randomization schedule to either Group A or B using online randomization software. A stratified randomization schedule was selected to balance the group assignments based on the covariate of sex. A team member who will have no contact with participants will obtain and employ the randomization schedule.
Primary purpose: TREATMENT

Brief summary: Chronic musculoskeletal pain (CMP) and lack of physical activity often co-exist, contributing to increased disability, non-communicable diseases (e.g., obesity, diabetes, hypertension), psychological comorbidity (e.g., anxiety and depression), and healthcare utilization and costs \[1-6\]. Many individuals with CMP seek assistance at emergency departments (ED). ED overuse has been an ongoing concern, with 1-in-5 Americans presenting to the ED at least once each year \[7\]. Of these visits, 24 million are for adults seeking help for chronic pain, with an additional 12 million due to exacerbations of an existing chronic pain condition \[8\]. In 2021, the fourth most common reason for seeking care in the ED related to a primary diagnosis involving the musculoskeletal system, with an estimated 9.5 million visits \[9\]. Most ED visits result in a 'treat and release' approach, potentially disrupting continuity of care and resulting in follow-up ED visits \[10\]. These ED visits for chronic pain are indicative of accessibility problems to community-based primary and preventative care, compounded by limited or no health insurance coverage \[10\]. Based on the Emergency Medical Treatment and Labor Act, EDs are required to stabilize all patients regardless of ability to pay \[10\]. To alleviate the burden of CMP on patients and EDs, improve access to quality healthcare, and mitigate initial and repeat ED visits, alternative options are required. Here we propose a novel group-based intervention involving pain education (PE) and physical activity (PA) implemented in CMP patients presenting to the ED of a community level hospital. The investigators will recruit 60 adults from a community hospital located in the Shenandoah Valley region of Virginia; participants will be randomized to either Pain Education and Active Knowledge (P.E.A.K.) Rx (24 sessions of group PE+ + PA) or usual care. Research assessments are conducted with both groups at study entry (baseline), 8-weeks, 3-months, and 6-months.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Sedentary (e.g., not meeting PA guidelines, assessed by ACSM PA vitals)
* English speaking and reading comprehension
* Not currently pregnant
* Diagnosed with CMP based on electronic health record:

  * Non-red flag presentation (e.g., red flags: current fracture, malignancy, infection, vascular issues, or in need of surgical intervention).
  * Persistent or recurrent pain for 3+ months, with at least moderate pain intensity level (Visual Analog Scale of 40/100)

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Baseline, post-intervention 8-weeks, 3-months, and 6-months
Secondary outcomes:
measure: Tampa Scale of Kinesiophobia
timeFrame: Baseline, post-intervention 8-weeks, 3-months, and 6-months
measure: Pain Catastrophizing Scale
timeFrame: Baseline, post-intervention 8-weeks, 3-months, and 6-months
measure: Patient Specific Functional Scale (PSFS)
timeFrame: Baseline, post-intervention 8-weeks, 3-months, and 6-months
measure: Saltin-Grimby physical activity scale for leisure time physical activity
timeFrame: Baseline, post-intervention 8-weeks, 3-months, and 6-months
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: Baseline, post-intervention 8-weeks, 3-months, and 6-months
measure: Self-report physical exercise
timeFrame: Baseline, post-intervention 8-weeks, 3-months, and 6-months
measure: Self-report occupational activity
timeFrame: Baseline, post-intervention 8-weeks, 3-months, and 6-months
Other outcomes:
Locations:
Study officials:
affiliation: Bridgewater College
name: Michael Ray, DC, MSc
role: PRINCIPAL_INVESTIGATOR
References: