Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)
- Conditions
- Musculoskeletal Pain
- Interventions
- Behavioral: Psychologically-Informed Physical Therapy (PIPT)
- Registration Number
- NCT05221125
- Lead Sponsor
- Duke University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psychologically-Informed Physical Therapy (PIPT) Psychologically-Informed Physical Therapy (PIPT) CBT-trained physical therapist evaluation and treatment with recommendation for Spine Health follow up after ED discharge
- Primary Outcome Measures
Name Time Method Number of patients enrolled as measured by patient log Post implementation, up to 6 weeks Number of patients that found treatment satisfactory via satisfactory questionnaire Post implementation, up to 6 weeks 5 point Likert-scale satisfaction scale
Number of ED patients eligible for recruitment 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
- Secondary Outcome Measures
Name Time Method Change in Anxiety Level ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge Subjective Units of Discomfort Scales (SUDS)
Change in Function ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge PROMIS-29
Number of repeat ED visits up to 3 months post discharge as measured by chart review
Change in Pain Score ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge 11-point Numeric Rating Scale (NRS) for current pain
Change in self efficacy ED pre-treatment (baseline); 1 and 3 months post discharge Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool
Number of pain medications prescribed up to 3 months post discharge as measured by chart review
Number of Spine Health visits for follow up PT up to 3 months post discharge as measured by chart review
Change in Quality of Life (QoL) ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge PROMIS-29
Change in severity of chronic pain ED pre-treatment (baseline); 1 and 3 months post discharge Simplified graded chronic pain scale
Number of Spine Health referrals for follow up PT At ED discharge (up to 48 hours) as measured by chart review
Number of patient hospitalizations up to 3 months post discharge as measured by chart review
Change in pain related distress ED pre-treatment (baseline); 1 and 3 months post discharge Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool
Trial Locations
- Locations (1)
Duke University Hospital Emergency Department
🇺🇸Durham, North Carolina, United States