Craniosacral Therapy in Migraine: A Feasibility Study

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.

Conditions

• Migraine Headaches

Interventions

OTHER

Craniosacral therapy

Eight weekly 45-minute sessions with therapist

PROCEDURE

Low strength static magnets

Placement of magnets on/around subject body by therapist; frequency: weekly for 45-minutes x 8 weeks

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• John Douglas Mann, MD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-09-30

Primary Completion

2009-05-31

Completion

2010-09-30

Countries

• United States

Study Locations