- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02054962
Persistent Pain Among Elderly Experiencing Motor Vehicle Collision (Elderly CRASH)
January 31, 2018 updated by: University of North Carolina, Chapel Hill
Persistent Pain and Associated Functional Decline Among Elderly Experiencing Motor Vehicle Collision
Chronic problems after traumatic events are common in non-elderly adults.
Previous studies have shown that after minor motor vehicle collision (MVC), 10-30% of non-elderly adult patients develop chronic regional pain (neck or back pain).
In addition, up to 1/3 of non-elderly adults will develop psychological sequelae, including posttraumatic stress disorder, depression, and anxiety disorders.
There have been no prospective studies examining the frequency or predictors of persistent pain or psychological sequelae in older adults.
The proposed study seeks to determine the frequency of persistent pain, psychological sequelae, and associated disability in older adults after minor MVC trauma and to identify candidate predictors for a model of adverse outcomes after MVC in this population.
200 individuals over 65 years of age will be recruited from emergency departments in four states with no-fault accident laws.
Patients who meet inclusion criteria and who consent to the emergency department (ED) study will undergo a 30-45 minute ED assessment of crash-related, psychosocial, and biological factors, and complete telephone follow-ups at 2 weeks, 6 weeks 6 months, and 12 months.
The wealth of information gained from this study will be used to determine the frequency of adverse events in older adults after MVC and to identify high risk elderly patients.
These results will inform subsequent development of secondary pharmacologic and/or behavioral interventions to prevent chronic pain and psychological sequelae after traumatic events in older adults.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
211
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Spectrum Health - Butterworth Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Elderly experiencing motor vehicle collision
Description
Inclusion Criteria:
- Patient speaks English, presented to ER less than 24 hours after an MVC, patient has an address and telephone
Exclusion Criteria:
- Patient
- is a prisoner,
- has fractures or an intracranial injury,
- has injuries that are life threatening or expected to result in hospitalization for more than 72 hours,
- is receiving end of life, hospice, or comfort care, or
- is considered ineligible by treating physician.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Elderly
The investigators intend to asses the effect of fear of movement, PTSD symptoms, and physical activity on persistent pain and functional decline.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average pain 6 months after Emergency Department visit
Time Frame: 6 months
|
Average pain during the past week with pain measured on a 0-10 scale.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical function at 6 months after Emergency Department visit
Time Frame: 6 months
|
Function measured on a 0-12 scale based on patient reported ability or difficulty walking, carrying objects, and climbing stairs (Simonsick E, et al. 2001).
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Timothy F Platts-Mills, MD, MSc, UNC Chapel Hill
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2017
Study Registration Dates
First Submitted
February 3, 2014
First Submitted That Met QC Criteria
February 3, 2014
First Posted (Estimate)
February 4, 2014
Study Record Updates
Last Update Posted (Actual)
February 5, 2018
Last Update Submitted That Met QC Criteria
January 31, 2018
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-0172
- K23AG038548 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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