Effectiveness of Craniosacral therapy, Bowen therapy, static touch, and standard exercise program on sleep quality in fibromyalgia syndrome: A protocol for a randomized controlled trial

Introduction: Sleep disturbance is a common feature seen in fibromyalgia syndrome (FMS), negatively impacting quality of life. FMS participants often opt for complementary therapies for their symptoms. However, there is limited evidence on manual therapies aimed at influencing sleep quality in those with FMS in India. Thus, this study aims to determine the effectiveness of Craniosacral therapy, Bowen therapy, static touch, and standard exercise program on sleep quality in participants with FMS. Methods: 132 participants diagnosed with FMS will be randomly allocated to one of four groups (Craniosacral therapy, Bowen therapy, static touch, or standard exercise program). The participants in all groups will receive once-a-week supervised sessions for 12 weeks, except those in the standard exercise group who will receive once-a-week supervised sessions on the 1st, 2nd, 3rd, 5th, 9th, and 12th week, and twice-weekly home exercises for those 6 weeks. Then, they will be asked to do thrice weekly home exercises for the remaining weeks up to 12 weeks. After 12 weeks, all the participants will be taught and asked to do the standard exercise program at home for another 12 weeks. A blinded assessor will take the outcomes at baseline, at the end of the 12th and 24th week of intervention. The study's primary outcome is the Pittsburgh sleep quality index. The secondary outcomes are pressure pain threshold, quality of life, physical function, fatigue, pain catastrophizing, kinesiophobia, and positive-negative affect. Repeated measures ANOVA and appropriate post hoc tests will be applied to analyze the between-group differences. Conclusion: The current study will provide insights into the treatment options to manage sleep and fibromyalgia symptoms. Trial registration: Clinical Trials Registry-India: CTRI/2020/04/024551 (April 9, 2020).