Methodological issues arising from a pilot RCT investigating the effectiveness of joint protection

Abstract

Aims: This article describes the difficulties encountered when attempting to evaluate the addition of joint protection education to an exercise programme in the treatment of patients with osteoarthritis (OA) of the hand. This involved a pilot study for a randomized controlled trial, which was carried out in order to inform the design of future studies. Methods: Subjects were recruited from rheumatology and orthopaedic out-patient clinics in a district general hospital for a 6 month period in 2006. They were assessed at baseline and 12 weeks after intervention. There were 2 intervention groups: one receiving exercise therapy and formal joint protection education from an occupational therapist over 2 sessions, supplemented with a joint protection information booklet, and the control group which received exercise therapy and informal joint protection advice. The primary outcome measures were pain and hand function measured using the hand pain visual analogue scale and the Cochin Hand Functional Disability Scale. Six patients were recruited with OA of the hand (mean age 59.2 years and mean disease duration 8.9 years) with three randomized to the intervention group, and three to the control group. Findings: There were methodological issues arising from the study, including sample recruitment issues, time scale, limited participant numbers and ethical constraints. No statistically valid data was gained to ascertain whether exercise therapy was more effective when given in conjunction with joint protection advice than without. Conclusions: Although some results were achieved that suggested there were improvements in the measures of perceived hand pain, health status, grip strength and pinch grip, these were not statistically meaningful. The improvements were greater in the control group, which received exercise therapy without joint protection advice. Hand function was reduced in both intervention groups. The reasons for this could not be answered in this study. A larger study would need to be undertaken in order to gain statistically valid data to evaluate the effectiveness of joint protection advice for people with OA hand.