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Clinical Trials/NCT06077526
NCT06077526
Not yet recruiting
Not Applicable

Alleviating Burden of Chronic Musculoskeletal Pain in the Emergency Department: P.E.A.K. Rx Feasibility Trial

Bridgewater College0 sites60 target enrollmentJanuary 13, 2026
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Bridgewater College
Enrollment
60
Primary Endpoint
Visual Analog Scale
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 13, 2026
End Date
May 15, 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Ray

Assistant Professor

Bridgewater College

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)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Visual Analog Scale

Time Frame: Baseline, post-intervention 8-weeks, 3-months, and 6-months

Quantitative metric of an individual's pain on a numerical scale. Scores range from 0 - 100, where 0 means no pain and 100 means maximum pain. 1-30 = mild 31-69 = moderate 70-100 = severe MCID of 12 point change \[60\].

Secondary Outcomes

  • Tampa Scale of Kinesiophobia(Baseline, post-intervention 8-weeks, 3-months, and 6-months)
  • Saltin-Grimby physical activity scale for leisure time physical activity(Baseline, post-intervention 8-weeks, 3-months, and 6-months)
  • Self-report physical exercise(Baseline, post-intervention 8-weeks, 3-months, and 6-months)
  • Self-report occupational activity(Baseline, post-intervention 8-weeks, 3-months, and 6-months)
  • Pain Catastrophizing Scale(Baseline, post-intervention 8-weeks, 3-months, and 6-months)
  • Patient Specific Functional Scale (PSFS)(Baseline, post-intervention 8-weeks, 3-months, and 6-months)
  • 36-Item Short Form Health Survey (SF-36)(Baseline, post-intervention 8-weeks, 3-months, and 6-months)

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