An interventional study of Psychologically-Informed Physical Therapy (PIPT) in Musculoskeletal Pain, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.
This study's enrollment of 86 is above the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CBT-trained physical therapist evaluation and treatment with recommendation for Spine Health follow up after ED discharge
Behavioral: Psychologically-Informed Physical Therapy (PIPT)
Usual care only
The PIPT group will receive evaluation and treatment based on the PT's assessment of the individual patient's clinical presentation and condition.
Number of ED patients eligible for recruitment as measured by patient log
Time frame: Post implementation, up to 6 weeks
Number of patients enrolled as measured by patient log
Time frame: Post implementation, up to 6 weeks
Number of patients retained in study as measured by patient log
Time frame: Post implementation, up to 6 weeks
Number of patients that found treatment satisfactory via satisfactory questionnaire
5 point Likert-scale satisfaction scale
Time frame: Post implementation, up to 6 weeks
Change in Pain Score
11-point Numeric Rating Scale (NRS) for current pain
Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in Anxiety Level
Subjective Units of Discomfort Scales (SUDS)
Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in Function
PROMIS-29
Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Change in Quality of Life (QoL)
PROMIS-29
Time frame: 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
Time frame: ED pre-treatment (baseline); 1 and 3 months post discharge
Change in self efficacy
Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool
Time frame: ED pre-treatment (baseline); 1 and 3 months post discharge
Change in severity of chronic pain
Simplified graded chronic pain scale
Time frame: ED pre-treatment (baseline); 1 and 3 months post discharge
Number of pain medications prescribed
as measured by chart review
Time frame: up to 3 months post discharge
Number of Spine Health referrals for follow up PT
as measured by chart review
Time frame: At ED discharge (up to 48 hours)
Number of Spine Health visits for follow up PT
as measured by chart review
Time frame: up to 3 months post discharge
Number of repeat ED visits
as measured by chart review
Time frame: up to 3 months post discharge
Number of patient hospitalizations
as measured by chart review
Time frame: up to 3 months post discharge
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Duke University