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.
The University of Queensland
30 participants
Mar 20, 2017
Interventional
Conditions
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
Inclusion Criteria4
- Individuals with Grade II WAD and within 48 hours of injury.
- Experiencing at least moderate pain (VAS>=5/10) on first measurement by ambulance or on arrival in ED.
- Age 18-65 years
- Proficient in written and spoken English
Exclusion Criteria12
- Known or suspected serious spinal pathology (e.g. metastatic disease of the spine);
- Confirmed fracture or dislocation at time of injury (WAD IV);
- WAD III (neurological compromise eg decreased reflexes, muscle power);
- Previous whiplash injury or neck pain condition requiring treatment;
- Patient Health Questionnaire-2 score of 3 or more
- Patients using gabapentin/pregabalin;
- Patients with known peripheral neuropathy;
- Known hypersensitivity to pregabalin use (hives, blisters, rash, dyspnea and wheezing);
- History of renal insufficiency; liver disease?
- Women who are pregnant or breastfeeding;
- History of psychiatric illness or substance abuse;
- Inability to speak and write in English (participants will be required to complete questionnaires written in English only).
Interested in this trial?
Get notified about updates and connect with the research team.
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)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12617000059369