Craniosacral Therapy in Migraine: A Feasibility Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Douglas Mann, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00665236
First received: April 21, 2008
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Migraine Headaches
Other: Craniosacral therapy
Procedure: Low strength static magnets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Craniosacral Therapy in Migraine: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • HIT-6 [ Time Frame: Post-treatment (end of 8 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Headache frequency [ Time Frame: Daily ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: September 2006
Study Completion Date: September 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Craniosacral therapy administered once a week for an hour by a trained craniosacral therapist.
Other: Craniosacral therapy
Eight weekly 45-minute sessions with therapist
Active Comparator: 2
Low-strength static magnets placed around the body for periods of up to an hour once a week.
Procedure: Low strength static magnets
Placement of magnets on/around subject body by therapist; frequency: weekly for 45-minutes x 8 weeks

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665236

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: John Douglas Mann, MD University of North Carolina, Chapel Hill
  More Information

Additional Information:
No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Douglas Mann, MD, Professor of Neurology, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00665236     History of Changes
Other Study ID Numbers: R21 AT002750-01A2, R21AT002750-01A2
Study First Received: April 21, 2008
Last Updated: November 30, 2012
Health Authority: United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014