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Not yet recruiting NCT06077526

Alleviating Burden of Chronic Musculoskeletal Pain in the Emergency Department

No phase Interventional Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: P.E.A.K. Rx, Usual Care.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral P.E.A.K. Rx
    Pain Education + Physical Activity Group Based Intervention
  • Other Usual Care
    Participants will receive the community hospital's usual care.

Primary outcome measures

  • Visual Analog Scale [Time frame: Baseline, post-intervention 8-weeks, 3-months, and 6-months]
Secondary outcome measures (7)
  • Tampa Scale of Kinesiophobia [Time frame: Baseline, post-intervention 8-weeks, 3-months, and 6-months]
  • Pain Catastrophizing Scale [Time frame: Baseline, post-intervention 8-weeks, 3-months, and 6-months]
  • Patient Specific Functional Scale (PSFS) [Time frame: Baseline, post-intervention 8-weeks, 3-months, and 6-months]
  • Saltin-Grimby physical activity scale for leisure time physical activity [Time frame: Baseline, post-intervention 8-weeks, 3-months, and 6-months]
  • 36-Item Short Form Health Survey (SF-36) [Time frame: Baseline, post-intervention 8-weeks, 3-months, and 6-months]
  • Self-report physical exercise [Time frame: Baseline, post-intervention 8-weeks, 3-months, and 6-months]
  • Self-report occupational activity [Time frame: Baseline, post-intervention 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06077526 · 23-010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗