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

NCT05221125 | Completed

• 1 other identifier: Pro00110289
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (4)

• Number of ED patients eligible for recruitment as measured by patient log

  Post implementation, up to 6 weeks

• Number of patients enrolled as measured by patient log

  Post implementation, up to 6 weeks

• Number of patients retained in study as measured by patient log

  Post implementation, up to 6 weeks

• Number of patients that found treatment satisfactory via satisfactory questionnaire

  5 point Likert-scale satisfaction scale

  Post implementation, up to 6 weeks

Secondary Outcomes (12)

• Change in Pain Score

  ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge

• Change in Anxiety Level

  ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge

• Change in Function

  ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge

• Change in Quality of Life (QoL)

  ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge

• Change in pain related distress

  ED pre-treatment (baseline); 1 and 3 months post discharge

Study Arms (2)

Psychologically-Informed Physical Therapy (PIPT)

EXPERIMENTAL

CBT-trained physical therapist evaluation and treatment with recommendation for Spine Health follow up after ED discharge

Behavioral: Psychologically-Informed Physical Therapy (PIPT)

Control

NO INTERVENTION

Usual care only

Interventions

Psychologically-Informed Physical Therapy (PIPT) BEHAVIORAL

The PIPT group will receive evaluation and treatment based on the PT's assessment of the individual patient's clinical presentation and condition.

Psychologically-Informed Physical Therapy (PIPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Duke Clinical Research Institute: collaborator

Study Sites (1)

Duke University Hospital Emergency Department

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephanie Eucker, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 2, 2022
• Study Start: June 6, 2022
• Primary Completion: April 20, 2023
• Study Completion: July 31, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)