Chronic PainNCT06077526
Alleviating Burden of Chronic Musculoskeletal Pain in the Emergency Department
A study testing P.E.A.K. Rx in people with Chronic Pain, run by Bridgewater College.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- P.E.A.K. Rx
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2026to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Alleviating Burden of Chronic Musculoskeletal Pain in the Emergency Department: P.E.A.K. Rx Feasibility Trial
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.
- Conditions
- Chronic Pain
- Being tested
- P.E.A.K. Rx, Usual Care
- Keywords
- musculoskeletal
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P.E.A.K. RxBehavioural
Also called Rehabilitation Therapy
Pain Education + Physical Activity Group Based Intervention
Usual CareOther
Participants will receive the community hospital's usual care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - P.E.A.K. Rx | Experimental | 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 2 meetings per week of pain education + physical activity. Receives: Behavioral: P.E.A.K. Rx |
| Control - Usual Care | Active comparator | Group B will receive the community hospital's usual care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: Baseline, post-intervention 8-weeks, 3-months, and 6-months
Secondary outcomes (7)
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].
Measured: Baseline, post-intervention 8-weeks, 3-months, and 6-months
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].
Measured: Baseline, post-intervention 8-weeks, 3-months, and 6-months
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].
Measured: Baseline, post-intervention 8-weeks, 3-months, and 6-months
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]
Measured: Baseline, post-intervention 8-weeks, 3-months, and 6-months
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].
Measured: Baseline, post-intervention 8-weeks, 3-months, and 6-months
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].
Measured: Baseline, post-intervention 8-weeks, 3-months, and 6-months
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)".
Measured: Baseline, post-intervention 8-weeks, 3-months, and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start13 Jan 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bridgewater College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Ray, Bridgewater College
- Investigators
- Michael Ray, DC, MSc, Principal investigator, Bridgewater College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077526
- Sponsor's protocol ID
- 23-010
- Status last verified
- Feb 2024
- First submitted
- 5 Oct 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In line with open science practices, all data and statistical code will be made available following publication of findings (via Open Science Framework).
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviating Burden of Chronic Musculoskeletal Pain in the Emergency Department: P.E.A.K. Rx Feasibility Trial
- ClinicalTrials.gov ID
- NCT06077526
- Acronym / sponsor ID
- 23-010
- Conditions
- Chronic Pain
- Keywords
- musculoskeletal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bridgewater CollegeUniversity, hospital or other
- Study start
- 13 Jan 2026 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental - P.E.A.K. Rx | Experimental | Behavioral: P.E.A.K. RxGroup 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 2 meetings per week of pain education + physical activity. |
| Control - Usual Care | Active comparator | Other: Usual CareGroup B will receive the community hospital's usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P.E.A.K. RxAlso: Rehabilitation TherapyPain Education + Physical Activity Group Based Intervention | Behavioural | Experimental - P.E.A.K. Rx |
| Usual CareParticipants will receive the community hospital's usual care. | Other | Control - Usual Care |
Primary outcome
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].
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Ray, DC, MSc principal investigator
Bridgewater College
Questions about this trial
What is this clinical trial studying?
A study testing P.E.A.K. Rx in people with Chronic Pain, run by Bridgewater College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Ray, DC, MSc (540-828-5416, bray@bridgewater.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Baseline, post-intervention 8-weeks, 3-months, and 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.