Duke University Hospital Emergency Department
Durham, North Carolina, 27710, United States
NCT Number: NCT05221125
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The PIPT group will receive evaluation and treatment based on the PT's assessment of the individual patient's clinical presentation and condition.
Time frame: Post implementation, up to 6 weeks
Time frame: Post implementation, up to 6 weeks
Time frame: Post implementation, up to 6 weeks
Time frame: Post implementation, up to 6 weeks
5 point Likert-scale satisfaction scale
Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
11-point Numeric Rating Scale (NRS) for current pain
Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Subjective Units of Discomfort Scales (SUDS)
Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
PROMIS-29
Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
PROMIS-29
Time frame: ED pre-treatment (baseline); 1 and 3 months post discharge
Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool
Time frame: ED pre-treatment (baseline); 1 and 3 months post discharge
Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool
Time frame: ED pre-treatment (baseline); 1 and 3 months post discharge
Simplified graded chronic pain scale
Time frame: up to 3 months post discharge
as measured by chart review
Time frame: At ED discharge (up to 48 hours)
as measured by chart review
Time frame: up to 3 months post discharge
as measured by chart review
Time frame: up to 3 months post discharge
as measured by chart review
Time frame: up to 3 months post discharge
as measured by chart review
Duke University
Other
Pilot Study of an Innovative Model to Provide Evidence-Based Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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