Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)

Duke University

Status

Completed

Conditions

Musculoskeletal Pain

Treatments

Behavioral: Psychologically-Informed Physical Therapy (PIPT)

Study type

Interventional

Funder types

Other

Identifiers

NCT05221125

Pro00110289

Details and patient eligibility

About

The purpose of this study is to assess the feasibility and acceptability of psychologically-informed physical therapy (PIPT) in the ED in a pilot study of ED patients with neck or back pain. We will conduct a single-site, prospective trial comparing the combined program in one group with a usual care-only group. Primary outcomes will focus on feasibility based on recruitment and retention rates, and acceptability based on a 5-point patient satisfaction scale, while secondary outcomes will include pain severity, pain interference, anxiety, physical function, opioid use, repeat ED visits, and hospitalizations at 1 hour and at 24 hours, 1 month and 3 months after ED discharge.

We will use pilot study results to develop a protocol for a larger pragmatic randomized clinical trial designed to rigorously evaluate PIPT in the ED combined with Spine Health follow up for ED patients with neck or back pain. We will perform a process evaluation of our proposed clinical trial study design, including characterizing and quantifying the degree of CBT and PT components used by treating PTs while in the ED and during Spine Health follow up, number of Spine Health visits attended in the first month, and integration into usual ED care. Qualitative interviews will be used to identify facilitators, barriers and potential solutions to intervention and research study procedures based on the patients' experience.

Enrollment

86 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adults (age 18 years or older),
Presented to the ED with pain in the neck and/or back,
A diagnosis of musculoskeletal pain as determined by an ED provider,
Able to read and understand the consent form in English.

Exclusion criteria

Suspected to have a non-musculoskeletal cause of pain;
Unable to provide informed consent or to comprehend or complete study measures or procedures due to cognitive impairment, including evidence of drug, medication or alcohol intoxication, or due to severe hearing or speech impairment;
Unable to safely participate due to critical illness, emergent surgical need, other serious medical condition (including active COVID-19 infection),
ED provider judgment.