Authors' objectives: Disabling and painful hand osteoarthritis (OA) affects 12% of adults 50 years and over in the population. The National Institute of Health and Care Excellence (NICE) has recently reviewed the costs and symptom benefits of chondroitin sulphate in OA and decided against recommending it for use in the NHS on current evidence but highlighting the need for further research. One recent trial, the FACT study, showed that chondroitin sulphate was better than placebo tablets and with few side effects but that improvements in patients pain and function after 6 months were generally small. However, this was a relatively small trial of short duration, conducted in a single rheumatology centre and involving patients with more severe, advanced hand osteoarthritis than would be generally seen in primary care. Given the limited options for treatment of OA of the small joints of the hand further research is now needed to determine whether chondroitin sulphate has long-term benefits on progression of hand OA on x-ray in primary care populations. To answer this question a longer term assessment of chondroitin sulphate is needed. The research questions are: What is the clinical effectiveness of chondroitin sulphate plus usual care compared with placebo chondroitin sulphate plus usual care in improving hand pain and function over 12 months in people with hand osteoarthritis in primary care? What is the cost-effectiveness of chondroitin sulphate plus usual care compared with placebo chondroitin sulphate plus usual care taking into account adverse events, referral to hand surgery and any subsequent joint surgery over 12 months in people with hand osteoarthritis? Does chondroitin sulphate plus usual care reduce structural disease progression of hand osteoarthritis at 24 months compared with placebo plus usual care? Any benefits of chondroitin sulphate may take weeks or months to emerge and so we will gather information from participants via postal questionnaires and telephone calls from a research nurse on 7 occasions over a two year period. The calls are also an opportunity to check on how participants are getting on with their treatment and to support their involvement in the trial. Our focus will be on the severity of hand pain over the first year, but we will also look at changes in difficulties with daily activities due to the hand problem, possible side effects, other treatments, and general health for up to 2 years after entering the study. We will invite participants to attend assessment clinics at the start of the study and at 1 and 2 years to tests their hand strength. Hand x-rays at the start of the study and 2 years will be used to evaluate claims that chondroitin sulphate slows down the osteoarthritic process. We will recruit 380 participants. Participants will attend a central primary care pharmacy every three months to collect prescriptions. Travel expenses will be paid for each visit. Any unused tablets will be returned and a tablet count will be undertaken. For any adverse events occurring between study contacts a helpline will be available for participants and their GP who will support usual care. If shown to be effective with limited side effects then chondroitin sulphate would provide an option as a safe first line analgesic for hand OA in addition to usual primary care.

Project Status: Completed

URL for project: http://www.nets.nihr.ac.uk/projects/hta/144504

Year Published: 2018

URL for published report: http://www.nets.nihr.ac.uk/projects/hta/144504

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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