Alleviating Burden of Chronic Musculoskeletal Pain in the Emergency Department

NCT ID: NCT06077526

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-13
• Study Completion Date: 2027-05-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental - P.E.A.K. Rx

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.

Group Type: EXPERIMENTAL

P.E.A.K. Rx

Intervention Type: BEHAVIORAL

Pain Education + Physical Activity Group Based Intervention

Control - Usual Care

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Participants will receive the community hospital's usual care.

Interventions

P.E.A.K. Rx

Pain Education + Physical Activity Group Based Intervention

Intervention Type: BEHAVIORAL

Usual Care

Participants will receive the community hospital's usual care.

Intervention Type: OTHER

Other Intervention Names

Rehabilitation Therapy

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bridgewater College

OTHER

Sponsor Role: lead

Responsible Party

Michael Ray

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Ray, DC, MSc

Role: PRINCIPAL_INVESTIGATOR

Bridgewater College

Central Contacts

Michael Ray, DC, MSc

Role: CONTACT

bray@bridgewater.edu

540-828-5416

Other Identifiers

23-010

Identifier Type: -

Identifier Source: org_study_id