Musculoskeletal Pain
Conditions
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.
Interventions
BEHAVIORALPsychologically-Informed Physical Therapy (PIPT)
The PIPT group will receive evaluation and treatment based on the PT's assessment of the individual patient's clinical presentation and condition.
Sponsors
Duke University
Duke Clinical Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Post implementation, up to 6 weeks | 5 point Likert-scale satisfaction scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| Change in Quality of Life (QoL) | ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge | PROMIS-29 |
| 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 |
| Change in self efficacy | ED pre-treatment (baseline); 1 and 3 months post discharge | Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool |
| Change in severity of chronic pain | ED pre-treatment (baseline); 1 and 3 months post discharge | Simplified graded chronic pain scale |
| Number of pain medications prescribed | up to 3 months post discharge | as measured by chart review |
| Number of Spine Health referrals for follow up PT | At ED discharge (up to 48 hours) | 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 |
| Number of repeat ED visits | up to 3 months post discharge | as measured by chart review |
| Number of patient hospitalizations | up to 3 months post discharge | as measured by chart review |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCorey Simon, PhD
Duke University
Outcome results
None listed