Yoga for pain and sleep quality in rheumatoid arthritis: study protocol for a pilot randomized controlled trial

Background:

Yoga is a popular complementary and alternative medicine (CAM) therapy among people with rheumatoid arthritis (RA), perceived as offering self-management options for physical and psychosocial symptoms associated with RA.

Objectives:

The primary aims of the current pilot study are (1) to assess the feasibility and safety of a relaxation-focused yoga intervention tailored for people with RA and (2) to estimate the effect of yoga on RA-related pain, sleep quality, functional disability, disease activity, quality of life, anxiety, depression, and fatigue.

Method:

Twenty-eight participants with at least minimum levels of RA-related pain and sleep disturbance will be recruited from a local public hospital database. Participants meeting inclusion criteria will be randomized into either a yoga group (receiving an 8-week program of once-weekly 75-minute relaxation-based yoga classes and thrice-weekly home practice), or a usual care control group. Outcomes will be assessed at baseline, 9, and 12 weeks. Feasibility is operationalized as acceptability (recruitment, adherence, participant retention, and participant satisfaction) and safety of the yoga intervention. Effect sizes for changes in pain, sleep quality, functional disability, disease activity, quality of life, mental health, and fatigue will be estimated.

Discussion:

Results of this pilot study will provide empirical data to determine if a larger, statistically powered main trial is feasible and safe in a national RA population. Additionally, participant feedback will provide information regarding further adaption and tailoring of the study protocol to a clinical RA population.

Trial registration:

Australian New Zealand Clinical Trials Registry ACTRN12612001019897 (registered 20/09/2012).