Development and preliminary evaluation of a chronic pain preventive intervention in extremity trauma patients

Not Applicable

Completed

• Conditions: Acute to chronic pain transition in extremity trauma patients; Signs and Symptoms

• Registration Number: ISRCTN91987302
• Lead Sponsor: McGill University

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28652226 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30684418 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-08
• Study Completion: 2018-03-31
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Pain intensity and pain interference with daily activities, measured by the modified Brief Pain Inventory at baseline (48 hours after hospital admission or 24 hours in postoperative phase), 3 months (at intervention end) and at 6 months<br><br> Updated 03/05/2017: Outcome measures will be recorded 24 hours to 7 days post-injury (baseline) and 3 and 6 months later (follow-up).<br>