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| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychologically-Informed Physical Therapy (PIPT) | Experimental | CBT-trained physical therapist evaluation and treatment with recommendation for Spine Health follow up after ED discharge |
|
| Control | No Intervention | Usual care only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychologically-Informed Physical Therapy (PIPT) | Behavioral | The PIPT group will receive evaluation and treatment based on the PT's assessment of the individual patient's clinical presentation and condition. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Eucker, MD, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital Emergency Department | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |