Persistent Pain After InjuryElderly CRASHNCT02054962
Persistent Pain Among Elderly Experiencing Motor Vehicle Collision
An observational study of Persistent Pain After Injury and Functional Decline After Injury, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Persistent Pain After Injury, Functional Decline After Injury
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly experiencing motor vehicle collision
Who may be able to join
- Patient speaks English, presented to ER less than 24 hours after an MVC, patient has an address and telephone
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spectrum Health - Butterworth Hospital
Grand Rapids, Michigan, 49503
About this study
Official title: 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.
- Keywords
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Average pain 6 months after Emergency Department visit
Average pain during the past week with pain measured on a 0-10 scale.
Measured: 6 months
Secondary outcomes (1)
Physical function at 6 months after Emergency Department visit
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startJun 2012
- Primary completionNov 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Pain After InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Timothy F Platts-Mills, MD, MSc, Study director, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054962
- Sponsor's protocol ID
- 11-0172
- Other IDs
- K23AG038548
- Acronym
- Elderly CRASH
- Status last verified
- Apr 2017
- First submitted
- 3 Feb 2014
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Pain and Associated Functional Decline Among Elderly Experiencing Motor Vehicle Collision
- ClinicalTrials.gov ID
- NCT02054962
- Acronym / sponsor ID
- Elderly CRASH / 11-0172
- Keywords
- Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jun 2012
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly | – | –The investigators intend to asses the effect of fear of movement, PTSD symptoms, and physical activity on persistent pain and functional decline. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly experiencing motor vehicle collision
Key inclusion criteria (1 listed)
- Patient speaks English, presented to ER less than 24 hours after an MVC, patient has an address and telephone
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Physical function at 6 months after Emergency Department visit
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy F Platts-Mills, MD, MSc study director
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Pain After Injury and Functional Decline After Injury, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average pain 6 months after Emergency Department visit (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.