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

BMC Complementary and Alternative Medicine BioMed Central Study protocol Open Access Craniosacral therapy for migraine: Protocol development for an exploratory controlled clinical trial John D Mann*1, Keturah R Faurot2, Laurel Wilkinson3, Peter Curtis4, Remy R Coeytaux3,4, Chirayath Suchindran5 and Susan A Gaylord2 Address: 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 and 5Department of Biostatistics, School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA Email: John D Mann* - ; Keturah R Faurot - ; Laurel Wilkinson - ; Peter Curtis - ; Remy R Coeytaux - ; Chirayath Suchindran - ; Susan A Gaylord - * Corresponding author Published: 9 June 2008 BMC Complementary and Alternative Medicine 2008, 8:28 doi:10.1186/1472-6882-8-28 Received: 15 April 2008 Accepted: 9 June 2008 This article is available from: http://www.biomedcentral.com/1472-6882/8/28 © 2008 Mann et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 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 nonpharmaceutical 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 lowstrength 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 Page 1 of 12 (page number not for citation purposes) BMC Complementary and Alternative Medicine 2008, 8:28 Background Migraine affects approximately 20 percent of the adult population, developing in the second and third decades and often persisting into late middle age and beyond [1,2]. Although the pathophysiology is not fully understood, there are clearly genetic, vascular and neural mechanisms involved [3]. Frequency and duration are highly variable and the onset is said to be triggered at times by stress, history of head or neck trauma, certain foods and hormonal changes in women [4-6]. Symptoms can be difficult to control and quality of life may deteriorate substantially. Management includes modification of diet, and recommendations for sleep, exercise, and stress reduction through bio-behavioral interventions as well as the use of a range of medications for prevention and acute treatment of migraine. Many of these medications are associated with significant side effects [7,8]. Furthermore, overuse of medications for the treatment of episodic migraines is a risk factor for developing chronic daily headache [9]. The study of non-pharmacological interventions for the treatment or prevention of migraine headaches is therefore warranted. Because conventional care for migraine is suboptimal, many individuals seek alternative treatment options [10,11]. http://www.biomedcentral.com/1472-6882/8/28 integrated with conventional care. Criteria for diagnosis, numbers of treatments, co-morbid conditions, psychosocial status, coping strategies for pain, prior trauma, qualifications of the practitioner, longitudinal follow-up, and changes in quality-of-life and overall function are not reported. Moreover, these study designs lack control groups and randomization. In this paper, we describe an ongoing feasibility study to assess the safety and efficacy of CST in the treatment of migraine. This is the first rigorous approach to the study of CST for migraine. The aims of the study are as follows: 1) To determine the feasibility of developing a clinical trial comparing usual medical care plus craniosacral therapy (CST) versus usual medical care and low-strength static magnet therapy (LSSM – attention-control) as treatments for the prevention of migraine; 2) To identify relevant secondary outcomes associated with usual care plus adjunctive CST; and 3) To identify and find solutions for potential problems in conducting a future large clinical trial to assess the efficacy of CST for the prevention of migraine. Methods Craniosacral therapy (CST) is one popular non-pharmacological approach to the treatment or prevention of migraine headaches for which there is limited evidence of safety and efficacy. CST involves manually identifying restrictions in the craniosacral system which includes the bones, membranes and ce (...truncated)