None listed
Conditions
Brief summary
PReventing chronic pain after whiplash Road Traffic Injury (PRioRTI) is a randomised, double-blinded, placebo-controlled, multi-centre Phase III trial to evaluate the effectiveness of early (within 96 hours of injury) treatment with pregabalin vs placebo in development of chronic pain after whiplash injury. 258 male and female participants, aged between 18 and 70 years old will be recruited in Emergency Departments (EDs) across several sites in Australia (Qld, NSW). Follow-up assessments will be completed at 6 weeks, 3-, 6- and 12-months using Participant Reported Outcome Measures completed by participants online in REDCap. It is hypothesised that participants who receive the pregabalin treatment will report lower levels of neck pain at the follow up time points than participants who receive the inactive placebo treatment.
Interventions
PReventing chronic pain after whiplash Road Traffic Injury (PRioRTI) is a randomised, triple-blinded, placebo-controlled, multi-centre Phase III trial to evaluate the effectiveness of early (within 96 hours of injury) treatment with pregabalin to prevent chronic pain after whiplash injury.
The trial intervention will be pregabalin oral capsule twice a day (BD) for the below planned dosage schedule:
- 75mg BD for 3 days
- Titrated up to 150mg BD for 11 days if tolerated
- Titrated up to 300mg B
PReventing chronic pain after whiplash Road Traffic Injury (PRioRTI) is a randomised, triple-blinded, placebo-controlled, multi-centre Phase III trial to evaluate the effectiveness of early (within 96 hours of injury) treatment with pregabalin to prevent chronic pain after whiplash injury. The trial intervention will be pregabalin oral capsule twice a day (BD) for the below planned dosage schedule: - 75mg BD for 3 days - Titrated up to 150mg BD for 11 days if tolerated - Titrated up to 300mg BD for 14 days if tolerated - Titrated down to 150mg BD for 7 days - 75mg BD for 7 days. If participants do not tolerate an up-titrated dose (i.e., 150mg or 300mg), they will remain at the maximal dose previously tolerated (e.g., if 300 mg BD not tolerated, they will remain at 150 mg BD until their scheduled down-titration to 75mg BD). Adherence will be monitored by a self-report dosage checklist, telehealth follow ups by the UQ Telehealth Team, and medication bottle return after completion of the treatment period The intervention will be delivered concurrent to evidence-based advice in the form of a booklet 'Whiplash Injury Recovery: a self-help guide (3rd edition)' which reflects current Australian Guidelines (i.e., Australian Clinical Guidelines for Health Professionals Managing People with Whiplash-Associated Disorders, 3rd edition, NSW State Insurance Regulatory Authority). This booklet was developed by the UQ research team and published by the Queensland Motor Accident Insurance Commission (available at https://maic.qld.gov.au/for-injured-people/rehabilitation-advice/whiplash-injury-recovery/) and is publicly available. It was not designed specifically for this study
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Participants are eligible to be included in the study only if all the following criteria apply: 1. Neck or upper back pain (Whiplash Associated Disorder (WAD) Grade II) 2. Within 96 hours of road traffic injury 3. Pain of at least 5/10 on numerical rating scale of pain intensity 4. Aged 18-70 years 5. Not admitted as a hospital inpatient (Emergency Deptment short stay units acceptable) 6. Participant is able to provide written informed consent and is willing to participate for the duration of the study and to follow study procedures
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: 1. Serious spinal pathology (e.g., fracture/dislocation WAD Grade IV, metastatic disease) 2. Neurological compromise (e.g., decreased reflexes, muscle power – WAD Grade III) 3. Peripheral neuropathy 4. Chronic pain condition for which patient is currently seeking treatment 5. Using gabapentin/pregabalin/other anticonvulsants 6. Known hypersensitivity to pregabalin (hives, blisters, rash, dyspnoea, wheezing) 7. Known renal disease causing renal insufficiency 8. Pregnancy or breastfeeding 9. History of psychiatric illness or substance abuse 10. History of depression or scoring 3 or greater on the PHQ-2 11. Inability to speak and write in English (to complete questionnaires)
Outcome results
None listed