Personalized Treatments for Acute Whiplash Injuries: a pilot study

INTERVENTION: The primary aim of this feasibility study is to conduct a series of N‐of‐1 trials comparing the effectiveness of a) evidence‐based advice (EBA), b) paracetamol and EBA, c) naproxen and EBA, and d) both paracetamol, naproxen and EBA to reduce daily neck pain and to prevent chronic pain at 3 months following whiplash injury in 15 'at‐risk' individuals. Using a novel multiple baseline design, all patients will receive a randomized sequence of three cycles of ten day treatment triplets. Data from first 3 days of each treatment period will be discarded to ensure no carryover. Followup questionnaires will be administered at approximately 3 months following trial completion. Intervention will commence as soon as possible but within 2‐weeks of injury and continue for 12 weeks. Intervention: All patients will be provided with an advice booklet Whiplash Injury Recovery: A Self Help Guide (2nd edition),co‐authored by Prof Sterling and 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 will receive 2 x 500 mg paracetamol capsules orally four times daily or naproxen sodium 2 x 137.5 mg capsules four times daily or capsules containing 500 mg paracetamol and 137.5 mg naproxen sodium, 2 capsules four times daily. A double dummy design will be used. Adherence with the study medications will be assessed in three ways: (1) daily self‐recorded medication intake, (2) the trial staff will ask about adherence during the planned telephone‐based reviews starting at 1 week post randomization and (3) counts of returned tablets following the completion of treatment. Participants will be asked to return all unused tablets for counting at the end of the treatment period in a reply paid post satchel. CONDITION: Acute whiplash PRIMARY OUTCOME: Adverse effects: Individual adverse effects and severity using the National Cancer Institutes of Health: Common Terminology Criteria for Adverse Events v3.0 Confidence to perform daily activities measured through patients’ self‐report of confidence to perform daily activities in the presence of neck pain or disability using a scale from 0 to 6, with 0 meaning not confident at all and 6 meaning completely confident. Daily neck pain intensity, and neck pain intensity at trial completion. Neck pain intensity is measured on the continuous numeric rating scale (NRS) of 0 to 10, and will represent the patients' self‐report of average pain intensity during last 24 hours. ; ; SECONDARY OUTCOME: Depression & Anxiety Stress Scales (DASS‐21) ED‐5Q‐5L Management decision at review 2 weeks post n‐of‐1 trial Neck Disability Index (NDI) Number of patients who lodge a compensation claim. This will be measured through patients' self‐report of compensation claims in the post‐trial diary and 3 month follow‐up diary. PTSD Checklist for DSM‐5 (PCL‐5); Pain Catastrophising Scale Patient global impression of change (‐5 to +5 scale) INCLUSION CRITERIA: • Individuals with Grade II WAD and within 2 weeks of injury. • Moderate to high risk according to the Whiplash Risk Stratification Tool (WhipPredict), a validated tool for predicting ongoing moderate/severe disability following acute whiplash injury. • Initial Numerical Rating Score (NRS) pain score of 5 or greater.