Background: Reflexology is commonly used as an adjunct to conventional treatment by patients with respiratory tract infections. The effect of reflexology needs to be tested in a full-scale randomized controlled study. Small early-phase trials can give an indication on whether full-size clinical trials are warranted. The objective of this study is to determine whether the study design is feasible in a full-scale study of reflexology as an add-on to usual care compared to usual care alone in acute rhinosinusitis, and further if there is a statistical indication of an effect of reflexology warranting a full-scale study.
Methods: 20 patients with symptoms compatible with acute rhinosinusitis, and an illness duration of 28 days or less were randomized to additional reflexology treatment along with usual medical care, or usual care alone. The patients scored how much each of 16 sinus-related symptoms bothered them in the past few days on a six-point scale (zero = no problem to five = severe problem). To determine if there is a statistical indication of an effect of reflexology warranting a full-scale study, the separation test was used.
Results: The methodology was considered feasible and could therefore be applied in a full-scale study of reflexology for acute rhinosinusitis. The mean reduction in symptom score from baseline to day two was 0.95 in the reflexology group and 0.78 in the control group. From baseline to day ten the mean reduction in symptom score was 2.12 in the reflexology group and 1.63 in the control group. A statistical indication of effect in a full-scale study in favor of reflexology was found from baseline to day ten but not from baseline to day two.
Conclusions: The research methodology in this study could be used in a full-scale study of reflexology in acute sinusitis. The results from the separation test indicates an effect warranting a full-scale study of reflexology regarding effects in acute sinusitis ten days after treatment.