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Persistent Pain Among Elderly Experiencing Motor Vehicle Collision (Elderly CRASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02054962
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
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.

Condition or disease
Persistent Pain After Injury Functional Decline After Injury

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Study Type : Observational
Actual Enrollment : 211 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Persistent Pain and Associated Functional Decline Among Elderly Experiencing Motor Vehicle Collision
Study Start Date : June 2012
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2017

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Biospecimen Retention:   Samples With DNA
Saliva samples collected for participants 1-150. Saliva, whole blood DNA and RNA collected for participants 151-250


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elderly experiencing motor vehicle collision
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054962


Locations
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United States, Michigan
Spectrum Health - Butterworth Hospital
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Aging (NIA)
Investigators
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Study Director: Timothy F Platts-Mills, MD, MSc UNC Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02054962    
Other Study ID Numbers: 11-0172
K23AG038548 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: April 2017
Keywords provided by University of North Carolina, Chapel Hill:
Pain
Additional relevant MeSH terms:
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Wounds and Injuries