A randomised controlled trial of wax baths as an additive therapy to hand exercises in patients with systemic sclerosis.

OBJECTIVE: The musculoskeletal features of systemic sclerosis (SSc) are a major cause of disability, causing limitations to movement and function. The study aim was to compare the effects of daily hand exercises with or without daily home wax bath hand treatment in patients with SSc. DESIGN: Assessor-blinded randomised controlled trial of parallel group design. SETTING: Single participating centre, undertaken in secondary care and in participants homes. PARTICIPANTS: 36 participants with hand skin tightening of SSc, two participants lost to follow up. INTERVENTIONS: Participants were randomised into wax bath versus no wax bath groups. Both groups in addition performed regular hand exercises as part of standard care. The study period was 9weeks, with further measures of outcome undertaken at 18weeks. MAIN OUTCOME MEASURES: The primary outcome measure was the Hand Mobility in Scleroderma test (HAMIS). Secondary outcomes measures were the Scleroderma Health Assessment Questionnaire, grip and pinch strength and the Cochin Hand Function Scale. RESULTS: Between group comparisons of HAMIS scores showed no evidence of effectiveness of the wax bath treatment at 9-week follow up (adjusted difference in means (95% CI) experimental-control -1.47 (-3.55 to 0.61), P=0.16) or at 18-week follow up (adjusted difference in means (95% CI) experimental-control 1.94 (-1.07 to 4.95), P=0.20). Analysis of secondary outcomes also showed no evidence for effectiveness of the wax bath treatment at either 9 or 18weeks. CONCLUSION: Our findings suggest that the addition of regular wax bath treatment confers no additional beneficial effect to standard care with daily home exercises. TRIAL REGISTRATION: ISRCTN registry (http://www.isrctn.com) ISRCTN 66736089.