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Behavioral Intervention

PIPT for Neck and Back Pain

N/A
Waitlist Available
Led By Stephanie Eucker, MD, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ed pre-treatment (baseline); 1 and 3 months post discharge
Awards & highlights

Study Summary

This trial will assess the feasibility and acceptability of psychologically-informed physical therapy (PIPT) for patients with neck or back pain in the emergency department (ED). Patients' satisfaction, pain severity, pain interference, anxiety, physical function, opioid use, repeat ED visits, and hospitalizations will be measured 1 hour and at 24 hours, 1 month and 3 months after ED discharge.

Who is the study for?
This trial is for adults over 18 who can read English, have come to the Emergency Department (ED) with neck or back pain diagnosed as musculoskeletal by an ED provider. It's not for those unable to consent, with cognitive impairments, critical illnesses, emergent surgical needs, serious medical conditions including active COVID-19, or suspected non-musculoskeletal pain causes.Check my eligibility
What is being tested?
The study tests psychologically-informed physical therapy (PIPT) in the ED against usual care. It measures how well PIPT works and if patients like it using satisfaction scales and looks at pain severity, function, anxiety levels, opioid use and hospital visits up to three months after discharge.See study design
What are the potential side effects?
Since this trial involves physical therapy rather than medication there may be minimal side effects such as temporary increased discomfort or muscle soreness post-treatment. Psychological aspects of PIPT could potentially cause emotional distress.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ed pre-treatment (baseline); 1 and 3 months post discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and ed pre-treatment (baseline); 1 and 3 months post discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of ED patients eligible for recruitment as measured by patient log
Number of patients enrolled as measured by patient log
Number of patients retained in study as measured by patient log
+1 more
Secondary outcome measures
Change in Anxiety Level
Change in Function
Change in Pain Score
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Psychologically-Informed Physical Therapy (PIPT)Experimental Treatment1 Intervention
CBT-trained physical therapist evaluation and treatment with recommendation for Spine Health follow up after ED discharge
Group II: ControlActive Control1 Intervention
Usual care only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psychologically-Informed Physical Therapy (PIPT)
2022
N/A
~90

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,983 Total Patients Enrolled
4 Trials studying Musculoskeletal Pain
1,103 Patients Enrolled for Musculoskeletal Pain
Duke Clinical Research InstituteOTHER
63 Previous Clinical Trials
241,446 Total Patients Enrolled
Stephanie Eucker, MD, PhDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
599 Total Patients Enrolled
1 Trials studying Musculoskeletal Pain
599 Patients Enrolled for Musculoskeletal Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why was this clinical trial established in the first place?

"The primary metric of success for this clinical trial will be the number of patients that report satisfaction with the treatment 6 weeks after implementation. Other, secondary outcomes include the number of emergency department visits and changes in pain score and quality of life."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)
2022. "Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05221125.
~30 spots leftby Apr 2025
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