None listed
Conditions
Brief summary
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, 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 and 6 months following whiplash injury in 'at-risk' individuals. The hypotheses are that, in people with acute whiplash injury: 1. Paracetamol, naproxen, and evidence-based advice will be more effective and safer than (i) paracetamol plus advice (ii) naproxen plus advice or (iii) advice alone in reducing neck pain intensity at 3 and 6 months following whiplash injury. 2. Paracetamol, naproxen, and evidence-based advice will be more effective and safer (i) paracetamol plus advice (ii) naproxen plus advice or (iii) advice alone in reducing disability, depression, posttraumatic stress symptoms and pain catastrophizing at 3 and 6 months following whiplash injury.
Interventions
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 fi
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.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Exclusion criteria
• Pre-existing 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, and still symptomatic; • Long term use of Paracetamol or NSAIDs for other chronic conditions (e.g. back pain, joint pain/arthritis) • Long term analgesics such as opiates, tramadol, etc and adjunctive analgesics for neuropathic pain such as pregabalin, amitriptyline, etc • Known hypersensitivity to paracetamol or naproxen or to any excipients (hives, blisters, rash, dyspnea and wheezing); • Asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; • History of renal insufficiency (eGFR<60ml/min/1.73m2 or ACR >3 mg/mmol) • Patients on diuretics, angiotensin converting enzyme inhibitors or angiotensin receptor blockers • Severe active liver disease that in the clinican’s judgement excludes the patient; • Patients who are severely malnourished, anorexic, septic, have a low body mass index or are chronic heavy users of alcohol. • Women who are pregnant or breastfeeding • History of severe or uncontrolled psychiatric illness or substance abuse • Patients who are smokers or obese (BMI > 30) • Inability to speak and write in English (participants will be required to complete questionnaires written in English only) • Older than 65 years • Use of concomitant drugs that increase the risk of upper GI bleeds/perforation e.g. anticoagulants, antiplatelet drugs, or corticosteroids • Current H. pylori infection or past infection where the clinician considers a risk of upper GI bleeding persists. • Prior history of peptic ulcer disease and/or gastrointestinal bleeding • History of inflammatory bowel disease • Uncontrolled hypertension, symptomatic heart failure and persistent peripheral edema. • Cardiovascular risk/history greater than or equal to 10% within 5 years or history of established CVD (eg unstable angina or MI, not including hypertension). • Patients undergoing or planning to have surgery during the next three months.
Outcome results
None listed