Craniosacral Therapy in Migraine: A Feasibility Study
Craniosacral Therapy in Migraine: A Feasibility Study
Treatment of migraine continues to be a major health problem today, despite many new
 pharmacological therapies. Limited clinical experience suggests that craniosacral therapy
 (CST) may be effective in the treatment of headache, including migraine. The primary aim of
 this proposal is to gather quality preliminary data on the usefulness of CST as an adjunct to
 conventional care for patients with migraine and to determine the feasibility of a larger,
 randomized clinical trial of CST in patients with migraine. Craniosacral therapists use a
 technique of gentle palpation of the head, neck and spine to release restrictions in cranial
 and peri-spinal tissues that are believed to contribute to a variety of health problems
 including headache. It is estimated that more than 2 million visits to CST practitioners are
 made each year, with more than 10 per cent of those for the complaint of headache. There has
 been no rigorous research examining the usefulness of CST for patients with migraine despite
 the impression of beneficial effects. Our limited preliminary data show significant,
 sustained benefit of CST in a small group of patients with migraine. The First Specific Aim
 is to determine the feasibility of developing a clinical trial comparing craniosacral therapy
 versus low-strength static magnets (attention-control complementary therapy) as a treatment
 for preventing migraine headaches. Patients with migraine, with or without aura, under care
 of a neurologist will be studied. After an 8-week baseline period, they will be randomized to
 one of two groups: 1) usual medical care plus 8 weeks of CST; or 2) usual medical care plus 8
 weeks of attention-control complementary treatment. Primary outcome measures will include: 1)
 headache-related quality of life, 2) headache frequency, and 3) perceived benefit in those
 receiving treatment. The Second Specific Aim is to identify relevant secondary outcomes
 associated with usual care plus adjunctive craniosacral therapy for migraine. Data collection
 will include demographics, headache intensity and duration, health status, headache-related
 disability, health care utilization, and medication use. The Third Specific Aim is to
 identify and find solutions for potential problems in conducting a larger clinical trial to
 assess the efficacy of CST for the prevention of migraine. Patients will be recruited from
 the University of North Carolina Headache Clinic and from local neurological practices.
 Duration of the study for each subject is 16 weeks. Length of the entire project is 2 years.
Inclusion Criteria:

 -  Eligible subjects will be 12 years of age and above, either gender, meeting the 2004
 International Classification of Headache Disorders (ICHD) criteria for migraine with
 or without aura, with a frequency of 5 to 14 per month and a headache history of more
 than two years. Patients must be under the care of one of the physicians participating
 in the study. Patients with chronic daily headache (more than 15 headache days per
 month) will be included only if they also have between 5 and 14 migraine headaches per
 month that can be clearly differentiated from chronic daily headache. Subjects or
 their caregivers must be willing and able to document headache characteristics and use
 of medications, as well as complete the assessment instruments. They must be able to
 come in for 8 weekly CST or LSSM interventions.

 Exclusion Criteria:

 -  Exclusion Criteria. Patients with significant, symptomatic depression, anxiety or
 psychosis requiring more than two psychotropic medications daily and/or more than two
 visits a month to a mental health care provider; those undergoing current treatment
 for a major medical illness such as malignancy, autoimmune or immune deficiency
 disorder; pregnancy; those with clotting disorders; those with a history of head
 trauma or cranial or neck surgery within two years; a prior history of use of CST or
 magnet therapy for headache; cardiac pacemakers; other implanted or external
 electrical devices.