OBJECTIVES: With growing evidence for craniosacral therapy (CST) effectiveness for pain management, the question about CST efficacy remained unclear. This study therefore aimed at investigating CST in comparison to sham treatment in chronic non-specific neck pain patients. METHODS: 54 blinded patients were randomized to either 8 weekly units of CST or light touch sham treatment. Outcomes were assessed before and after treatment (week 8) and a further 3 months later (week 20). The primary outcome was pain intensity on a visual analogue scale; secondary outcomes included pain on movement, pressure pain sensitivity, functional disability, health-related quality of life, well-being, anxiety, depression, stress perception, pain acceptance, body awareness, patients' global impression of improvement and safety. RESULTS: In comparison to sham, CST patients reported significant and clinically relevant effects on pain intensity at week 8 (-21%mm; 95%-CI -32.6 to 9.4; p = 0.001; d = 1.02) as well as at week 20 (-16.8%mm; 95%-CI -27.5 to 6.1; p = 0.003; d = 0.88). Minimal clinically important differences in pain intensity at week 20 were reported by 78% of the CST patients, while 48% even had substantial clinical benefit. Significant differences at week 8 and 20 were also found for pain on movement, functional disability, physical quality of life and patients' global improvement. Pressure pain sensitivity and body awareness were significantly improved only at week 8; anxiety only at week 20. No serious adverse events were reported. DISCUSSION: CST was both specifically effective and safe in reducing neck pain intensity and may improve functional disability and quality of life up to 3 months post intervention.

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