Clinical trial NCT05221125: Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Clinical Research Institute
First posted: 2022-02-02
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of ED patients eligible for recruitment as measured by patient log
timeFrame: Post implementation, up to 6 weeks
measure: Number of patients enrolled as measured by patient log
timeFrame: Post implementation, up to 6 weeks
measure: Number of patients retained in study as measured by patient log
timeFrame: Post implementation, up to 6 weeks
measure: Number of patients that found treatment satisfactory via satisfactory questionnaire
timeFrame: Post implementation, up to 6 weeks
Secondary outcomes:
measure: Change in Pain Score
timeFrame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
measure: Change in Anxiety Level
timeFrame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
measure: Change in Function
timeFrame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
measure: Change in Quality of Life (QoL)
timeFrame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
measure: Change in pain related distress
timeFrame: ED pre-treatment (baseline); 1 and 3 months post discharge
measure: Change in self efficacy
timeFrame: ED pre-treatment (baseline); 1 and 3 months post discharge
measure: Change in severity of chronic pain
timeFrame: ED pre-treatment (baseline); 1 and 3 months post discharge
measure: Number of pain medications prescribed
timeFrame: up to 3 months post discharge
measure: Number of Spine Health referrals for follow up PT
timeFrame: At ED discharge (up to 48 hours)
measure: Number of Spine Health visits for follow up PT
timeFrame: up to 3 months post discharge
measure: Number of repeat ED visits
timeFrame: up to 3 months post discharge
measure: Number of patient hospitalizations
timeFrame: up to 3 months post discharge
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital Emergency Department
state: North Carolina
Study officials:
affiliation: Duke University
name: Stephanie Eucker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: