Status:

COMPLETED

Craniosacral Therapy in Migraine: A Feasibility Study

Lead Sponsor:

University of North Carolina, Chapel Hill

Collaborating Sponsors:

National Center for Complementary and Integrative Health (NCCIH)

Conditions:

Migraine Headaches

Eligibility:

All Genders

12-80 years

Phase:

NA

Brief 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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2010

Estimated Enrollment :

66 Patients enrolled

Trial Details

Trial ID

NCT00665236

Start Date

September 1 2006

End Date

September 1 2010

Last Update

December 4 2012

Active Locations (1)

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599