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Alleviating Burden of Chronic Musculoskeletal Pain in the Emergency Department

Primary Purpose

Chronic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
P.E.A.K. Rx
Usual Care
Sponsored by
Bridgewater College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring musculoskeletal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - 18 years of age or older Sedentary (e.g., not meeting PA guidelines) 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental - P.E.A.K. Rx

    Control - Usual Care

    Arm Description

    Group A intervention, P.E.A.K. Rx, will be supervised and directed by healthcare clinicians, known as Pain Coaches. P.E.A.K. Rx will involve 3 meetings per week of pain education + physical activity.

    Group B will receive the community hospital's usual care.

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale
    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 Outcome Measures

    Tampa Scale of Kinesiophobia
    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].
    Pain Catastrophizing Scale
    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].
    Patient Specific Functional Scale (PSFS)
    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].
    Saltin-Grimby physical activity scale for leisure time physical activity
    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]
    36-Item Short Form Health Survey (SF-36)
    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].
    Self-report physical exercise
    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].
    Self-report occupational activity
    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)".

    Full Information

    First Posted
    October 5, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Bridgewater College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06077526
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2025 (Anticipated)
    Primary Completion Date
    June 2026 (Anticipated)
    Study Completion Date
    June 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bridgewater College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain
    Keywords
    musculoskeletal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental - P.E.A.K. Rx
    Arm Type
    Experimental
    Arm Description
    Group A intervention, P.E.A.K. Rx, will be supervised and directed by healthcare clinicians, known as Pain Coaches. P.E.A.K. Rx will involve 3 meetings per week of pain education + physical activity.
    Arm Title
    Control - Usual Care
    Arm Type
    Active Comparator
    Arm Description
    Group B will receive the community hospital's usual care.
    Intervention Type
    Behavioral
    Intervention Name(s)
    P.E.A.K. Rx
    Other Intervention Name(s)
    Rehabilitation Therapy
    Intervention Description
    Pain Education + Physical Activity Group Based Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Usual Care
    Intervention Description
    Participants will receive the community hospital's usual care.
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale
    Description
    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].
    Time Frame
    Baseline, post-intervention 8-weeks, 3-months, and 6-months
    Secondary Outcome Measure Information:
    Title
    Tampa Scale of Kinesiophobia
    Description
    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].
    Time Frame
    Baseline, post-intervention 8-weeks, 3-months, and 6-months
    Title
    Pain Catastrophizing Scale
    Description
    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].
    Time Frame
    Baseline, post-intervention 8-weeks, 3-months, and 6-months
    Title
    Patient Specific Functional Scale (PSFS)
    Description
    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].
    Time Frame
    Baseline, post-intervention 8-weeks, 3-months, and 6-months
    Title
    Saltin-Grimby physical activity scale for leisure time physical activity
    Description
    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]
    Time Frame
    Baseline, post-intervention 8-weeks, 3-months, and 6-months
    Title
    36-Item Short Form Health Survey (SF-36)
    Description
    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].
    Time Frame
    Baseline, post-intervention 8-weeks, 3-months, and 6-months
    Title
    Self-report physical exercise
    Description
    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].
    Time Frame
    Baseline, post-intervention 8-weeks, 3-months, and 6-months
    Title
    Self-report occupational activity
    Description
    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)".
    Time Frame
    Baseline, post-intervention 8-weeks, 3-months, and 6-months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - 18 years of age or older Sedentary (e.g., not meeting PA guidelines) 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Ray, DC, MSc
    Phone
    540-828-5416
    Email
    bray@bridgewater.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Ray, DC, MSc
    Organizational Affiliation
    Bridgewater College
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    In line with open science practices, all data and statistical code will be made available following publication of findings (via Open Science Framework).

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