Craniosacral Therapy in Migraine: A Feasibility Study

Migraine Headaches Clinical Trial

Official title:

Craniosacral Therapy in Migraine: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665236
• Other study ID #: R21AT002750-01A2
• Secondary ID: R21AT002750-01A2
• Status: Completed
• Phase: N/A
• First received: April 21, 2008
• Last updated: November 30, 2012
• Start date: September 2006
• Est. completion date: September 2010

Study information

• Verified date: November 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine Headaches

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIT-6		Post-treatment (end of 8 weeks)	No
Secondary	Headache frequency		Daily	No

External Links

•   UNC's Program on Integrative Medicine