RecruitingPhase 3Phase 4ACTRN12617000059369

Pregabalin for acute whiplash

Pregabalin vs placebo in targeting pronociceptive mechanisms to prevent chronic pain after whiplash injury in at-risk individuals – feasibility study for a randomised controlled trial.

Sponsor

The University of Queensland

Enrollment

30 participants

Start Date

Mar 20, 2017

Study Type

Interventional

Conditions

Whiplash Injury

Summary

We will conduct a feasibility study for a randomised controlled trial examining the effectiveness of pregabalin to prevent chronic pain following whiplash injury in ‘at-risk’ individuals. This feasibility study will hone eligibility criteria, test recruitment strategies, and develop a model for recruitment for the subsequent full scale trial. The primary aim of this current study is to assess the feasibility of the RCT by measuring recruitment rates (number of patients approached, number consenting to participate, and number eligible to to be randomised; missing data and participant attrition). and obtaining qualitative feedback from patients and doctors about their experience of the trial and suggestions for improvement. The secondary aims are to: 1) Investigate the effectiveness of pregabalin to decrease disability, depression, posttraumatic stress symptoms, and pain catastrophizing; 2) To conduct an economic evaluation of the pregabalin intervention. We hypothesise that pregabalin used in acute whiplash injury will prevent or modulate pro-nociceptive mechanisms and improve health outcomes for this treatment resistant condition, and that the study will be feasible.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medication called pregabalin, taken in the days right after a whiplash injury, can prevent the pain from becoming long-lasting and chronic. Whiplash from car accidents is very hard to treat once it becomes a chronic condition, so this study focuses on acting early — within 48 hours of injury — in people who already have significant pain. Participants are randomly assigned to receive either pregabalin or a placebo (dummy pill) for a short period. You may be eligible if: - You are between 18 and 65 years old - You had a Grade II whiplash injury within the last 48 hours - Your pain level is at least 5 out of 10 - You are proficient in written and spoken English You may NOT be eligible if: - You have a serious spinal condition or confirmed bone fracture from the injury - You have neurological problems such as reduced reflexes or muscle weakness from the injury - You had a previous whiplash injury or neck problem requiring treatment - You already take gabapentin or pregabalin - You have kidney disease, peripheral nerve damage, or liver disease - You are pregnant or breastfeeding - You have a history of psychiatric illness or substance abuse - You scored 3 or more on the depression screening (PHQ-2) - You have a known allergy to pregabalin Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients will be provided with an advice booklet Whiplash Injury Recovery: A Self Help Guide (2nd edition) published by the Motor Accident Insurance Commission (MAIC), Qld. It provides information about whiplash; assurance about prognosis; advice to stay active and resume working as well as information on correct posture; pictorial descriptions of specific exercises for the neck and upper limbs and information on resuming functional daily activities. This second edition of the booklet was written based on consumer and health care professional feedback via focus groups. The booklet is based on the recommendations of the current Australian Guidelines for Whiplash Management. Patients randomized to the experimental arm of the study will receive 1 pregabalin capsule (75 mg) orally twice daily with the first dose taken before discharge during the initial ED presentation. Patients will continue on this dose for 3 days after which time the dose could be titrated to 150mg twice daily if the previous dose is well tolerated. The dose could be further increased to 300 mg twice daily after the second week if 150 mg twice daily is well tolerated. The dose will be reduced to the previously tolerated level if the higher dose is not well tolerated after 3 days. The study medication will be continued for 28 days, after which a dose of 300 mg twice daily will be weaned to 150 mg twice daily for 3 days and then 75 mg twice daily for 3 days, a dose of 150 mg twice daily will be weaned to 75 mg twice daily for 6 days and a dose of 75 mg twice daily continued for 6 days. Dose de-escalation in lower maximum tolerated doses will use proportionately lower doses over the same time schedule. The dose escalation/reduction regimen for our trial has been used in previous pregabalin trials. All patients will be asked to continue taking the medicines (active or placebo) for a period of 28 days with a subsequent 6 days of weaning. The prescription of pregabalin in this way is standard clinical practice. Adherence will be measured by self-report in patient diaries and pill counts.

Locations(1)

Gold Coast University Hospital - Southport

QLD, Australia

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ACTRN12617000059369