Study protocol

Craniosacral therapy for migraine: Protocol development for an exploratory controlled clinical trial

John D Mann¹ , Keturah R Faurot² , Laurel Wilkinson³ , Peter Curtis⁴ , Remy R Coeytaux^3,4 , Chirayath Suchindran⁵ and Susan A Gaylord²

¹Department of Neurology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

²Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

³Integrative Health Center of Chapel Hill, Chapel Hill, NC, USA

⁴Department of Family Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

⁵Department of Biostatistics, School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

author email corresponding author email

BMC Complementary and Alternative Medicine 2008, 8:28doi:10.1186/1472-6882-8-28

Published:	9 June 2008

Abstract

Background

Migraine affects approximately 20% of the population. Conventional care for migraine is suboptimal; overuse of medications for the treatment of episodic migraines is a risk factor for developing chronic daily headache. The study of non-pharmaceutical approaches for prevention of migraine headaches is therefore warranted. Craniosacral therapy (CST) is a popular non-pharmacological approach to the treatment or prevention of migraine headaches for which there is limited evidence of safety and efficacy. In this paper, we describe an ongoing feasibility study to assess the safety and efficacy of CST in the treatment of migraine, using a rigorous and innovative randomized controlled study design involving low-strength static magnets (LSSM) as an attention control intervention.

Methods

The trial is designed to test the hypothesis that, compared to those receiving usual care plus a treatment with low-strength static magnets (attention-control complementary therapy), subjects receiving usual medical care plus CST will demonstrate significant improvement in: quality-of-life as measured by the Headache Impact Test (HIT-6); reduced frequency of migraine; and a perception of clinical benefit. Criteria for inclusion are either gender, age > 11, English or Spanish speaking, meeting the International Classification of Headache Disorders (ICHD) criteria for migraine with or without aura, a headache frequency of 5 to 15 per month over at least two years. After an 8 week baseline phase, eligible subjects are randomized to either CST or an attention control intervention, low strength static magnets (LSSM). To evaluate possible therapist bias, videotaped encounters are analyzed to assess for any systematic group differences in interactions with subjects.

Results

169 individuals have been screened for eligibility, of which 109 were eligible for the study. Five did not qualify during the baseline phase because of inadequate headache frequency. Nineteen have withdrawn from the study after giving consent.

Conclusion

This report endorses the feasibility of undertaking a rigorous randomized clinical trial of CST for migraine using a standardized CST protocol and an innovative control protocol developed for the study. Subjects are able and willing to complete detailed headache diaries during an 8-week baseline period, with few dropouts during the study period, indicating the acceptability of both interventions.

Trial Registration

ClinicalTrials.gov NCT00665236