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临床试验/NCT06077526
NCT06077526尚未招募不适用

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

Bridgewater College0 个研究点目标入组 60 人开始时间: 2026年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Visual Analog Scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 未提供

结局指标

主要结局

Visual Analog Scale

时间窗: 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 \[60\].

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Ray

Assistant Professor

Bridgewater College

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