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Trial registered on ANZCTR
Registration number
ACTRN12617000059369
Ethics application status
Approved
Date submitted
4/01/2017
Date registered
11/01/2017
Date last updated
5/12/2017
Type of registration
Prospectively registered
Titles & IDs
Public title
Pregabalin for acute whiplash
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Scientific title
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.
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Secondary ID [1]
290804
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Whiplash Injury
301453
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Condition category
Condition code
Musculoskeletal
301176
301176
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0
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Other muscular and skeletal disorders
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Injuries and Accidents
301258
301258
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
296721
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Treatment: Drugs
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Comparator / control treatment
Patients in the control group will also receive the information booklet described above. A placebo will be administered as a control and this will be compared to the pregabalin drug administration.. Both drugs and administration regimes will be identical to ensure blinding.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Neck pain intensity at 3 months post randomisation from baseline between the treatment groups. Neck pain intensity is measured on the continuous numeric rating scale (NRS) of 0 to 10, and will represent the patient's self-report of average pain intensity during last 24 hours.
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Assessment method [1]
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Timepoint [1]
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Neck pain intensity will be assessed at 3 months post randomisation.
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Secondary outcome [1]
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1. Neck pain intensity (NRS 24 hours) at 6-and 12-month follow-up from baseline between the treatment groups;
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Assessment method [1]
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Timepoint [1]
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6 month and 12 month followup
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Secondary outcome [2]
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Neck Disability Index (NDI) scores 3, -6 and 12-months from baseline, compared between the treatments
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Assessment method [2]
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Timepoint [2]
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3, 6 months and 12 months from baseline
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Secondary outcome [3]
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Pain Catastrophising Scale (PCS) scores at follow-up from baseline, compared between treatments
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Assessment method [3]
330372
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Timepoint [3]
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At the 5-week, 3-month, 6-month, 12-month follow ups
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Secondary outcome [4]
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Between treatment differences in Posttraumatic Stress Diagnostic Scale (PDS) symptom score, measured during follow-up
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Assessment method [4]
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Timepoint [4]
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At the 5-week, 3-month, 6-month, 12-month follow ups
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Secondary outcome [5]
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Between treatment differences in Depression, Anxiety & Stress scale (DASS), measured during follow-up
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Assessment method [5]
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Timepoint [5]
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At the 5-week, 3-month, 6-month, 12-month follow ups
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Secondary outcome [6]
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Generic measure of health status scores (SF-12) during follow-up between the treatment groups
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Assessment method [6]
330375
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Timepoint [6]
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At the 5-week, 3-month, 6-month, 12-month follow ups
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Secondary outcome [7]
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Comparison of proportion of patients who lodge a compensation claim during follow-up, between the treatment groups. This will be self-reported on the followup questionnaires
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Assessment method [7]
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Timepoint [7]
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At the 5-week, 3-month, 6-month, 12-month follow ups
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Secondary outcome [8]
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Number of doses of break through medication. Self reported by the patients.
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Assessment method [8]
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Timepoint [8]
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At the 5-week, 3-month, 6-month, 12-month follow ups
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Secondary outcome [9]
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Feasibility by estimating rates of:
i. Recruitment (number of patients approached, number consenting to participate, and number eligible to be randomised);
ii. Missing data and participant attrition.
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Assessment method [9]
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Timepoint [9]
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At the end of the trial
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Secondary outcome [10]
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Recruitment strategies tested and a model for recruitment to a full trial developed.
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Assessment method [10]
341083
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Timepoint [10]
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At the end of the trial
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Secondary outcome [11]
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Relevant factors identified that could create barriers to subsequent study completion, and strategies developed to overcome these
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Assessment method [11]
341084
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Timepoint [11]
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At end of the trial
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Secondary outcome [12]
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Qualitative feedback obtained from ED clinicians, GPs, and patients on their experience with the trial and areas for improvement to inform a full scale trial.
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Assessment method [12]
341085
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Timepoint [12]
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At end of the trial
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Eligibility
Key inclusion criteria
1. Individuals with Grade II WAD and within 48 hours of injury.
2. Experiencing at least moderate pain (VAS>=5/10) on first measurement by ambulance or on arrival in ED.
3. Age 18-65 years
4. Proficient in written and spoken English
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Known or suspected serious spinal pathology (e.g. metastatic disease of the spine);
2. Confirmed fracture or dislocation at time of injury (WAD IV);
3. WAD III (neurological compromise eg decreased reflexes, muscle power);
4. Previous whiplash injury or neck pain condition requiring treatment;
5. Patient Health Questionnaire-2 score of 3 or more
6. Patients using gabapentin/pregabalin;
7. Patients with known peripheral neuropathy;
8. Known hypersensitivity to pregabalin use (hives, blisters, rash, dyspnea and wheezing);
9. History of renal insufficiency; liver disease?
10. Women who are pregnant or breastfeeding;
11. History of psychiatric illness or substance abuse;
12. Inability to speak and write in English (participants will be required to complete questionnaires written in English only).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3 / Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
All analyses will be conducted on an intention to treat basis and by a statistician blinded to group allocation. The primary outcome of change in neck pain intensity at 3 months from baseline will be compared between the treatment groups using standard analysis of variance technique, and the 95% confidence intervals of changes between the groups will be presented. Analyses of data from earlier studies and our simulation studies suggest approximate normality of the distribution of change in intensity score. Missing data will be examined for its randomness and addressed with multiple imputations, if required.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
11/01/2017
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Actual
20/03/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
5
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Gold Coast University Hospital - Southport
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Recruitment postcode(s) [1]
14936
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4215 - Southport
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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NHMRC Centre of Research Excellence in Road Traffic Injury Recovery
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Address [1]
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GPO Box 1421 Canberra ACT 2601
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Country [1]
295228
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Australia
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Funding source category [2]
295230
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University
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Name [2]
295230
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Menzies Health Institute of Queensland
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Address [2]
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G40 Griffith Health Centre, Level 8.86
Gold Coast campus
Griffith University QLD 4222
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Country [2]
295230
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Australia
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Primary sponsor type
University
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Name
The University of Queensland
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Address
Faculty of Health and Behavioural Sciences, The University of Queensland
Level 7, UQ Oral Health Centre, 288 Herston Road, Herston QLD 4006
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Country
Australia
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Secondary sponsor category [1]
294058
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None
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Name [1]
294058
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Address [1]
294058
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Country [1]
294058
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296573
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Gold Coast Hospital and Health Service Human Research Ethics Committee (HRECs)
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Ethics committee address [1]
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1 Hospital Boulevard
Southport QLD 4215
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Ethics committee country [1]
296573
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Australia
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Date submitted for ethics approval [1]
296573
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10/11/2016
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Approval date [1]
296573
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07/12/2016
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Ethics approval number [1]
296573
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HREC/16/QGC/296
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Summary
Brief 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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Michele Sterling
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Address
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Recover Injury Research Centre, Faculty of Health and Behavioural Sciences, The University of Queensland
Level 7, UQ Oral Health Centre, 288 Herston Road, Herston QLD 4006
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Country
71338
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Australia
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Phone
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61 488 196 862
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Fax
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Email
71338
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[email protected]
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Contact person for public queries
Name
71339
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Dr Jane Nikles
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Address
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Recover Injury Research Centre, Faculty of Health and Behavioural Sciences, The University of Queensland
Level 7, UQ Oral Health Centre, 288 Herston Road, Herston QLD 4006
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Country
71339
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Australia
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Phone
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61 408 599 033
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Fax
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Email
71339
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[email protected]
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Contact person for scientific queries
Name
71340
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Dr Jane Nikles
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Address
71340
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Recover Injury Research Centre, Faculty of Health and Behavioural Sciences, The University of Queensland
Level 7, UQ Oral Health Centre, 288 Herston Road, Herston QLD 4006
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Country
71340
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Australia
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Phone
71340
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61 408 599 033
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Fax
71340
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Email
71340
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Use of and attitudes to the role of medication for acute whiplash injury: A preliminary survey of emergency department doctors.
2019
https://dx.doi.org/10.1111/1742-6723.13190
Embase
Pregabalin vs placebo to prevent chronic pain after whiplash injury in at-risk individuals: Results of a feasibility study for a large randomised controlled trial.
2022
https://dx.doi.org/10.1097/j.pain.0000000000002362
Embase
Pregabalin versus placebo in targeting pro-nociceptive mechanisms to prevent chronic pain after whiplash injury in at-risk individuals -a feasibility study for a randomised controlled trial.
2018
https://dx.doi.org/10.1186/s13063-018-2450-9
N.B. These documents automatically identified may not have been verified by the study sponsor.
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