Craniosacral therapy for migraine: protocol development for an exploratory controlled clinical trial.
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 Nineteen have withdrawn from the study after giving consent.


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov NCT00665236.
Department of Neurology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. mannj@neurology.unc.edu
John D
JD
Mann
Keturah R
KR
Faurot
Laurel
L
Wilkinson
Peter
P
Curtis
Remy R
RR
Coeytaux
Chirayath
C
Suchindran
Susan A
SA
Gaylord
D002985:Clinical Protocols; D005240:Feasibility Studies; D006801:Humans; D008280:Magnetics / Q000627:therapeutic use; D008405:Massage; D008499:Medical Records; D008881:Migraine Disorders / Q000628:therapy*; D017060:Patient Satisfaction; D018579:Patient Selection; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D016896:Treatment Outcome