This trial is active, not recruiting.

Conditions persistent pain after injury, functional decline after injury
Sponsor University of North Carolina, Chapel Hill
Collaborator National Institute on Aging (NIA)
Start date June 2012
End date December 2016
Trial size 250 participants
Trial identifier NCT02054962, 11-0172, K23AG038548


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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
We intend to asses the effect of fear of movement, PTSD symptoms, and physical activity on persistent pain and functional decline.

Primary Outcomes

Average pain 6 months after Emergency Department visit
time frame: 6 months

Secondary Outcomes

Physical function at 6 months after Emergency Department visit
time frame: 6 months

Eligibility Criteria

Male or female participants at least 65 years old.

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, patient has fractures or an intracranial injury, patient has injuries that are life threatening or expected to result in hospitalization for more than 72 hours, patient is receiving end of life, hospice, or comfort care, or patient is considered ineligible by treating physician.

Additional Information

Official title Persistent Pain and Associated Functional Decline Among Elderly Experiencing Motor Vehicle Collision
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.