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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN91987302
Enrollment
56
Registered
2015-12-08
Start date
2016-05-01
Completion date
Unknown
Last updated
2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute to chronic pain transition in extremity trauma patients Signs and Symptoms

Interventions

Current interventions as of 03/05/2017: Following the first phase of the study (acceptability assessment of the intervention according to clinicians’ and patients’ perspectives), the i

Sponsors

McGill University
Lead Sponsor
Sacred Heart Hospital of Montréal (Hôpital du Sacré-Coeur de Montréal)
Collaborator
McGill University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Secondary

MeasureTime frame
1. Pain self-efficacy, measured by the Pain Self-Efficacy Questionnaire 2. Pain acceptance, measured by the Chronic Pain Acceptance Questionnaire-8 items 3. Pain catastrophizing, measured by the Pain Catastrophizing Scale 4. Pain-related fear, measured by the Tampa Scale for Kinesiophobia 5. Anxiety and depression, measured by the Hospital Anxiety and Depression Scale 6. Health status, measured by the SF-12v2 7. Patients overall evaluation with different aspects of their responses to treatment, including: 7.1. Pain relief 7.2. Improvement in functioning 7.3. Quality of life 7.4. Global condition, measured by the Patient Global Impression of Change These outcomes will be measured at baseline (48 hours after hospital admission or 24 hours in postoperative phase), 3 months (at intervention end) and at 6 months 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).

Primary

MeasureTime frame
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 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).

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026