Credibility of low-strength static magnet therapy as an attention control intervention for a randomized controlled study of CranioSacral therapy for migraine headaches.

BACKGROUND: Developing valid control groups that generate similar perceptions and expectations to experimental complementary and alternative (CAM) treatments can be challenging. The perceived credibility of treatment and outcome expectancy often contributes to positive clinical responses to CAM therapies, thereby confounding efficacy data. As part of a clinical feasibility study, credibility and expectancy data were obtained from subjects suffering from migraine who received either CranioSacral therapy (CST) or an attention-control, sham, and low-strength magnet (LSSM) intervention. OBJECTIVE: The objective of this study was to evaluate whether the LSSM intervention generated similar levels of subject credibility and expectancy compared to CST. DESIGN: This was a two-arm randomized controlled trial. SUBJECTS: Sixty-five (65) adults with moderate to severe migraine were the subjects of this study. INTERVENTIONS: After an 8-week baseline, subjects were randomized to eight weekly treatments of either CST (n=36) or LSSM (n=29). The latter involved the use of a magnet-treatment protocol using inactive and low-strength static magnets designed to mimic the CST protocol in terms of setting, visit timing, body positioning, and therapist-subject interaction. OUTCOME MEASURES: A four-item, self-administered credibility/expectancy questionnaire, based on a validated instrument, was completed after the first visit. RESULTS: Using a 0-9 rating scale, the mean score for perceived logicality of treatment was significantly less for LSSM (5.03, standard deviation [SD] 2.34) compared to CST (6.64, SD 2.19). Subject confidence that migraine would improve was greater for CST (5.94, SD 2.01) than for LSSM (4.9, SD 2.21), a difference that was not statistically significant. Significantly more subjects receiving CST (6.08, SD 2.27) would confidently recommend treatment to a friend than those receiving LSSM (4.69, SD 2.49). CONCLUSIONS: Although LSSM did not achieve a comparable level of credibility and expectancy to the CST, several design and implementation factors may have contributed to the disparity. Based on analysis of these factors, the design and implementation of a future study may be improved.

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. 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.