Craniosacral Therapy in Migraine: A Feasibility Study
Condition: Migraine Headaches
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Craniosacral therapy; Low strength static magnets
Intervention type(s): Other; Procedure
Intervention description(s): Eight weekly 45-minute sessions with therapist; Placement of magnets on/around subject body by therapist; frequency: weekly for 45-minutes x 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine