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

Pilot Study of an Innovative Model to Provide Evidence-Based Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain
• Intervention / Treatment: Behavioral: Psychologically-Informed Physical Therapy (PIPT)

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual care only
Experimental: Psychologically-Informed Physical Therapy (PIPT); CBT-trained physical therapist evaluation and treatment with recommendation for Spine Health follow up after ED discharge	Behavioral: Psychologically-Informed Physical Therapy (PIPT); The PIPT group will receive evaluation and treatment based on the PT's assessment of the individual patient's clinical presentation and condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Score	11-point Numeric Rating Scale (NRS) for current pain	ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in Anxiety Level	Subjective Units of Discomfort Scales (SUDS)	ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in Function	PROMIS-29	ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in Quality of Life (QoL)	PROMIS-29	ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in pain related distress	Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool	ED pre-treatment (baseline); 1 and 3 months post discharge
Change in self efficacy	Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool	ED pre-treatment (baseline); 1 and 3 months post discharge
Change in severity of chronic pain	Simplified graded chronic pain scale	ED pre-treatment (baseline); 1 and 3 months post discharge
Number of pain medications prescribed	as measured by chart review	up to 3 months post discharge
Number of Spine Health referrals for follow up PT	as measured by chart review	At ED discharge (up to 48 hours)
Number of Spine Health visits for follow up PT	as measured by chart review	up to 3 months post discharge
Number of repeat ED visits	as measured by chart review	up to 3 months post discharge
Number of patient hospitalizations	as measured by chart review	up to 3 months post discharge

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Duke Clinical Research Institute
• Investigators: Principal Investigator: Stephanie Eucker, MD, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Actual): April 20, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Emergencies; Back Pain; Musculoskeletal Pain
• Other Study ID Numbers: Pro00110289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No