Alleviating Burden of Chronic Musculoskeletal Pain in the Emergency Department

NCT06077526 | Not Yet Recruiting

• 1 other identifier: 23-010
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain

Keywords

musculoskeletal

Outcome Measures

Primary Outcomes (1)

• 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 \[60\].

  Baseline, post-intervention 8-weeks, 3-months, and 6-months

Secondary Outcomes (7)

• Tampa Scale of Kinesiophobia

  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

• Saltin-Grimby physical activity scale for leisure time physical activity

  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

Study Arms (2)

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.

Behavioral: P.E.A.K. Rx

Control - Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

P.E.A.K. Rx BEHAVIORAL

Pain Education + Physical Activity Group Based Intervention

Also known as: Rehabilitation Therapy

Experimental - P.E.A.K. Rx

Usual Care OTHER

Participants will receive the community hospital's usual care.

Control - Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Bridgewater College: lead

MeSH Terms

Conditions

Chronic Pain

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Michael Ray, DC, MSc

  Bridgewater College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Ray, DC, MSc

CONTACT

540-828-5416; bray@bridgewater.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: January 13, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: February 12, 2024

Record last verified: 2024-02