A randomized controlled trial investigating the effects of craniosacral therapy on pain and heart rate variability in fibromyalgia patients

Abstract

Context: Fibromyalgia is a prevalent musculoskeletal disorder associated with widespread mechanical tenderness, fatigue, non-refreshing sleep, depressed mood and pervasive dysfunction of the autonomic nervous system: tachycardia, postural intolerance, Raynaud’s phenomenon and diarrhoea. Objective: To determine the effects of craniosacral therapy on sensitive tender points and heart rate variability in patients with fibromyalgia. Design: A randomized controlled trial. Subjects: Ninety-two patients with fibromyalgia were randomly assigned to an intervention group or placebo group. Interventions: Patients received treatments for 20 weeks. The intervention group underwent a craniosacral therapy protocol and the placebo group received sham treatment with disconnected magnetotherapy equipment. Main measures: Pain intensity levels were determined by evaluating tender points, and heart rate variability was recorded by 24-hour Holter monitoring. Results: After 20 weeks of treatment, the intervention group showed significant reduction in pain at 13 of the 18 tender points ( P < 0.05). Significant differences in temporal standard deviation of RR segments, root mean square deviation of temporal standard deviation of RR segments and clinical global impression of improvement versus baseline values were observed in the intervention group but not in the placebo group. At two months and one year post therapy, the intervention group showed significant differences versus baseline in tender points at left occiput, left-side lower cervical, left epicondyle and left greater trochanter and significant differences in temporal standard deviation of RR segments, root mean square deviation of temporal standard deviation of RR segments and clinical global impression of improvement. Conclusion: Craniosacral therapy improved medium-term pain symptoms in patients with fibromyalgia.