Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)
Primary Purpose
Musculoskeletal Pain
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychologically-Informed Physical Therapy (PIPT)
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Pain
Eligibility Criteria
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.
Sites / Locations
- Duke University Hospital Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Psychologically-Informed Physical Therapy (PIPT)
Control
Arm Description
CBT-trained physical therapist evaluation and treatment with recommendation for Spine Health follow up after ED discharge
Usual care only
Outcomes
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
Number of patients that found treatment satisfactory via satisfactory questionnaire
5 point Likert-scale satisfaction scale
Secondary Outcome Measures
Change in Pain Score
11-point Numeric Rating Scale (NRS) for current pain
Change in Anxiety Level
Subjective Units of Discomfort Scales (SUDS)
Change in Function
PROMIS-29
Change in Quality of Life (QoL)
PROMIS-29
Change in pain related distress
Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool
Change in self efficacy
Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool
Change in severity of chronic pain
Simplified graded chronic pain scale
Number of pain medications prescribed
as measured by chart review
Number of Spine Health referrals for follow up PT
as measured by chart review
Number of Spine Health visits for follow up PT
as measured by chart review
Number of repeat ED visits
as measured by chart review
Number of patient hospitalizations
as measured by chart review
Full Information
NCT ID
NCT05221125
First Posted
January 31, 2022
Last Updated
September 21, 2023
Sponsor
Duke University
Collaborators
Duke Clinical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05221125
Brief Title
Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)
Official Title
Pilot Study of an Innovative Model to Provide Evidence-Based Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
April 20, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Duke Clinical Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychologically-Informed Physical Therapy (PIPT)
Arm Type
Experimental
Arm Description
CBT-trained physical therapist evaluation and treatment with recommendation for Spine Health follow up after ED discharge
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care only
Intervention Type
Behavioral
Intervention Name(s)
Psychologically-Informed Physical Therapy (PIPT)
Intervention Description
The PIPT group will receive evaluation and treatment based on the PT's assessment of the individual patient's clinical presentation and condition.
Primary Outcome Measure Information:
Title
Number of ED patients eligible for recruitment as measured by patient log
Time Frame
Post implementation, up to 6 weeks
Title
Number of patients enrolled as measured by patient log
Time Frame
Post implementation, up to 6 weeks
Title
Number of patients retained in study as measured by patient log
Time Frame
Post implementation, up to 6 weeks
Title
Number of patients that found treatment satisfactory via satisfactory questionnaire
Description
5 point Likert-scale satisfaction scale
Time Frame
Post implementation, up to 6 weeks
Secondary Outcome Measure Information:
Title
Change in Pain Score
Description
11-point Numeric Rating Scale (NRS) for current pain
Time Frame
ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Title
Change in Anxiety Level
Description
Subjective Units of Discomfort Scales (SUDS)
Time Frame
ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Title
Change in Function
Description
PROMIS-29
Time Frame
ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Title
Change in Quality of Life (QoL)
Description
PROMIS-29
Time Frame
ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge
Title
Change in pain related distress
Description
Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool
Time Frame
ED pre-treatment (baseline); 1 and 3 months post discharge
Title
Change in self efficacy
Description
Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool
Time Frame
ED pre-treatment (baseline); 1 and 3 months post discharge
Title
Change in severity of chronic pain
Description
Simplified graded chronic pain scale
Time Frame
ED pre-treatment (baseline); 1 and 3 months post discharge
Title
Number of pain medications prescribed
Description
as measured by chart review
Time Frame
up to 3 months post discharge
Title
Number of Spine Health referrals for follow up PT
Description
as measured by chart review
Time Frame
At ED discharge (up to 48 hours)
Title
Number of Spine Health visits for follow up PT
Description
as measured by chart review
Time Frame
up to 3 months post discharge
Title
Number of repeat ED visits
Description
as measured by chart review
Time Frame
up to 3 months post discharge
Title
Number of patient hospitalizations
Description
as measured by chart review
Time Frame
up to 3 months post discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Eucker, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital Emergency Department
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)
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