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

Study Overview
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Brief Summary
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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.

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

Conditions
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Musculoskeletal Pain

Intervention / Treatment
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* Behavioral: Psychologically-Informed Physical Therapy (PIPT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |