Does naltrexone reduce pain or disability after a whiplash?

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Design: this is a randomised, double-blinded, placebo-controlled trial in patients with whiplash injury. it aims at testing whether a medicine we are trialling may reduce long term pain after a whiplash injury. Each group will include 20 participants, who will be recruited after presenting to the emergency department at JHC. Detailed information sheet will be supplied to all participants prior to asking them to consent for the trail. Participants will voluntarily enter the trial, have their rights of declining participation and terminating their participation explained to them in the first interview and provided to them in writing. All their data will be secured on a computer, not shared with anyone outside this research group. All their personal details will be destroyed once data analysis and journal submission is complete. You will be entering one of the groups by the order of chance using opaque sealed envelops. The investigators will have no prior knowledge which group you will fall into and no knowledge of which group you belong to during the phases of this study. If you are randomly selected into the treatment group, you will receive the active medicine, called low dose naltrexone. it is given as one tablet at bed time. If you are randomly selected into the 'placebo' group, you will be give a' sham' tablet to take daily at bed time. The study will run an observation period of 2 weeks, followed by a treatment period of 8 weeks, and a follow up visit at 6 months from the time you were randomised into a group. Observation phase: all participants will have daily numerical pain scale reported (0-100), zero equals no pain at all and a 100 means the worst imaginable pain, highest neck disability index (NDI) will be measured based on a validated questionnaire, Sensory testing (called QST) of your sensitivity to graded cold on specific sites of the body will be tested,. An assessment of your stress, anxiety and depression will be conducted using a specific questionnaire (DASS21), This will be done at same time points as the measures of neck disability and skin testing. A baseline blood test for inflammatory markers will obtained once from each participant. Treatment phase: placebo group will receive sham tablets at bed time for 8 weeks, treatment group will receive LDN at bed time for 8 weeks. All participants will record their NPS at the same time of taking the tablet. NDI, QST and DASS21 will be conducted at end of treatment period, and CRP will be tested once at end of the 8 weeks treatment period. Follow-up: at 6 months from entering a study group; we are planning to measure NPS, NDI, conduct QSTs, DASS21 and repeat the CRP test once per visit.

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