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NCT Number: NCT06077526

Alleviating Burden of Chronic Musculoskeletal Pain in the Emergency Department

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

P.E.A.K. Rx

Behavioral

Pain Education + Physical Activity Group Based Intervention

Other names: Rehabilitation Therapy

Usual Care

Other

Participants will receive the community hospital's usual care.

Primary outcomes

  1. 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

  1. Tampa Scale of Kinesiophobia

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

    Quantitative metric asking 17 questions using a 4-point Likert scale regarding a participant's fear and avoidance of movement. Scores range from 17 to 68, where 17 means no kinesiophobia and higher scores indicate increasing severity of kinesiophobia. Scores ≥ 37 indicate kinesiophobia. MCID of 7.5-9 points [61].

  2. Pain Catastrophizing Scale

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

    13-item quantitative metric assessing participant's catastrophic thinking about their pain experience, contributing to rumination, magnification, and learned helplessness. Utilizes 4-item scale to assess frequency of particular thoughts, 0 = not at all to 4 = all the time. Total score ranges from 0 - 52. Score ≥ 30 indicates catastrophizing.

    MCID of 11 points for those considered to be engaging in catastrophic thinking (baseline score >30 points) [62].

  3. Patient Specific Functional Scale (PSFS)

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

    Assesses impact of pain on participant's function by identification of difficult or unable to perform activities. 11-point Likert scale ranks participant's current level of difficulty for each activity (0 = unable to perform, 10 = able to perform activity at same level before injury or problem).

    Assess improvement in function of valued activities post intervention. MCID is categorized:

    Small change = 1.3 Medium change = 2.3 Large change = 2.7 [63].

  4. Saltin-Grimby physical activity scale for leisure time physical activity

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

    Assesses participants perception of their leisure time activities. Describe your exercise and physical exertion in leisure time. If your activity varies much, for example between summer and winter, then give an average. The question refers only to the last year.

    Four different levels:

    "Reading, watching TV, or other sedentary activity," "Walking, cycling, or other forms of exercise at least 4 hours a week (here including walking or cycling to place of work, Sunday walking, etc.)," "Participation in recreational sports, heavy gardening, etc. (note: duration of activity at least 4 hours a week)" and "Participation in hard training or sports competitions, regularly several times a week." 4 levels renamed: "inactive," "low," "moderate," and "vigorous," respectively [65]

  5. 36-Item Short Form Health Survey (SF-36)

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

    A health-related quality of life survey assessing eight dimensions: physical function, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health. Scores for each dimension range from 0 (worst level of functioning) to 100 (best level of functioning). Total sore MCID of 4.6 points [64].

  6. Self-report physical exercise

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

    Exercise assessment through 3 questions on frequency, duration, and intensity, where the respondents will be asked to estimate their weekly average. Frequency question: "How often do you exercise (i.e., walking, skiing, swimming or training/sports)?" Duration question: "For how long (time) do you exercise?" Intensity question "If you exercise-how hard do you exercise?"

    Frequency categories:

    "never", "less than once a week", "once a week", "2 to 3 times a week", or "approximately every day".

    Duration categories:

    "less than 15 minutes", "15 to 29 minutes", "30 to 60 minutes", or "more than 1 hour."

    Intensity categories:

    "Easy-you do not become short-winded or sweaty", "You become short-winded and sweaty", and "Hard-you become exhausted". Categorized as "low", "moderate", and "hard" respectively [65].

  7. Self-report occupational activity

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

    Assess occupational physical activity.

    Question: "If you have paid or unpaid work, which statement describes your work best? Response categories:

    "mostly sedentary work (e.g., office work)", "work that requires a lot of walking (e.g., shop assistant, light industrial work)", and "work that requires a lot of walking and lifting (e.g., nursing, construction, or heavy manual labor)".

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Ray, DC, MSc

CONTACT

[email protected]

540-828-5416

Sponsors and collaborators

Lead sponsor

Bridgewater College

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 11, 2023
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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