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

Musculoskeletal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05221125
• Other study ID #: Pro00110289
• Status: Completed
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 31, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Emergencies
• Musculoskeletal Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Hospital Emergency Department	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Duke Clinical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ED patients eligible for recruitment as measured by patient log		Post implementation, up to 6 weeks
Primary	Number of patients enrolled as measured by patient log		Post implementation, up to 6 weeks
Primary	Number of patients retained in study as measured by patient log		Post implementation, up to 6 weeks
Primary	Number of patients that found treatment satisfactory via satisfactory questionnaire	5 point Likert-scale satisfaction scale	Post implementation, up to 6 weeks
Secondary	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
Secondary	Change in Anxiety Level	Subjective Units of Discomfort Scales (SUDS)	ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Secondary	Change in Function	PROMIS-29	ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Secondary	Change in Quality of Life (QoL)	PROMIS-29	ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Secondary	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
Secondary	Change in self efficacy	Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool	ED pre-treatment (baseline); 1 and 3 months post discharge
Secondary	Change in severity of chronic pain	Simplified graded chronic pain scale	ED pre-treatment (baseline); 1 and 3 months post discharge
Secondary	Number of pain medications prescribed	as measured by chart review	up to 3 months post discharge
Secondary	Number of Spine Health referrals for follow up PT	as measured by chart review	At ED discharge (up to 48 hours)
Secondary	Number of Spine Health visits for follow up PT	as measured by chart review	up to 3 months post discharge
Secondary	Number of repeat ED visits	as measured by chart review	up to 3 months post discharge
Secondary	Number of patient hospitalizations	as measured by chart review	up to 3 months post discharge