Craniosacral Therapy in Migraine: A Feasibility Study
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ClinicalTrials.gov Identifier: NCT00665236 |
Recruitment Status
:
Completed
First Posted
: April 23, 2008
Last Update Posted
: December 4, 2012
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Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Douglas Mann, MD, University of North Carolina, Chapel Hill
Tracking Information | ||||
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First Submitted Date ICMJE | April 21, 2008 | |||
First Posted Date ICMJE | April 23, 2008 | |||
Last Update Posted Date | December 4, 2012 | |||
Study Start Date ICMJE | September 2006 | |||
Actual Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
HIT-6 [ Time Frame: Post-treatment (end of 8 weeks) ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00665236 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Headache frequency [ Time Frame: Daily ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Craniosacral Therapy in Migraine: A Feasibility Study | |||
Official Title ICMJE | Craniosacral Therapy in Migraine: A Feasibility Study | |||
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 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Migraine Headaches | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Mann JD, Faurot KR, Wilkinson L, Curtis P, Coeytaux RR, Suchindran C, Gaylord SA. Craniosacral therapy for migraine: protocol development for an exploratory controlled clinical trial. BMC Complement Altern Med. 2008 Jun 9;8:28. doi: 10.1186/1472-6882-8-28. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
66 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | September 2010 | |||
Actual Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 12 Years to 80 Years (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00665236 | |||
Other Study ID Numbers ICMJE | R21AT002750-01A2( U.S. NIH Grant/Contract ) R21AT002750-01A2 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Douglas Mann, MD, University of North Carolina, Chapel Hill | |||
Study Sponsor ICMJE | University of North Carolina, Chapel Hill | |||
Collaborators ICMJE | National Center for Complementary and Integrative Health (NCCIH) | |||
Investigators ICMJE |
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PRS Account | University of North Carolina, Chapel Hill | |||
Verification Date | November 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |