Development and pilot randomized controlled trial of a hybrid web-based and in-person self-management intervention to prevent acute to chronic pain transition post major lower extremity trauma

McGill University0 sites56 target enrollmentDecember 8, 2015

Overview

Registry

who.int

Start Date

December 8, 2015

End Date

March 31, 2018

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. 18 years of age or older
•2\. Able to read and speak French
•3\. Have a lower ET
•4\. At risk of developing chronic pain
•Although several chronic pain risk factors have been identified in ET patients, no screening tool is readily available. Since acute pain intensity has been the sole chronic pain risk factor consistently found in this population and the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendation to consider such inclusion criterion , a decision was made to consider this factor when screening patients at risk of developing chronic pain. Hence, patients who will present pain intensity \> 4/10 at least once a day upon movement in the first 48 hours post\-injury, which corresponds to moderate to severe pain intensity, will be enrolled. This criterion is based on the experience of the investigator who has witnessed high pain intensities in such specific time periods. Considering that lower extremity injury has been identified as a chronic pain risk factor and the need to optimize sample homogeneity, only patients with such injuries will be recruited.
•Updated 03/05/2017: Patients will be enrolled if they present pain intensity \=4/10 upon movement 24 hours post\-injury.

•1\. Unable to understand French
•2\. Spinal cord injury
•3\. Other trauma associated with high\-intensity pain \[\> two ribs fracture or surgical abdominal trauma
•4\. Transfer to a regional hospital (14% of ET patients are returned to their referral hospital)
•5\. Cognitive impairment \[i.e., dementia, moderate\-severe traumatic brain injury – Glasgow coma scale score \< 13/15 limiting the capacity to participate to the intervention and to complete questionnaires
•6\. Hospitalized in the intensive care unit (ICU)
•7\. Need for more than 7 days of hospitalization in the ICU
•Added 03/05/2017:
•8\. Amputation