- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00665236
Craniosacral Therapy in Migraine: A Feasibility Study
November 30, 2012 updated by: Douglas Mann, MD, University of North Carolina, Chapel Hill
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Craniosacral therapy administered once a week for an hour by a trained craniosacral therapist.
|
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.
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Placement of magnets on/around subject body by therapist; frequency: weekly for 45-minutes x 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HIT-6
Time Frame: Post-treatment (end of 8 weeks)
|
Post-treatment (end of 8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Headache frequency
Time Frame: Daily
|
Daily
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John Douglas Mann, MD, University of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
April 21, 2008
First Submitted That Met QC Criteria
April 21, 2008
First Posted (Estimate)
April 23, 2008
Study Record Updates
Last Update Posted (Estimate)
December 4, 2012
Last Update Submitted That Met QC Criteria
November 30, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT002750-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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