Craniosacral Therapy or Magnet Therapy for Migraine Headache
Migraine is a common form of serious headache that affects about 10% of the US population. Conventional treatment for migraine is costly and often does not work well. Migraine medications may be associated with serious side effects. When added to their medications, complementary therapies, such as craniosacral therapy and magnets, may help migraine patients.
The purpose of this NIH-sponsored research study is to learn whether craniosacral therapy or the use of magnets can improve symptoms and the quality of life for migraine sufferers.
What Else Should I Know?
Craniosacral therapy is a gentle massage technique designed to release areas of restriction in the soft tissues of your head and spine. The benefit of craniosacral therapy for migraine has been widely reported and may come from affecting pain pathways. This effect has not been well studied. Magnets have been widely used for pain in the neck and back, but their effectiveness in relieving headache patients has not been well studied. Magnets can be used safely by almost everyone.
What will happen if i join the study?
First, you will meet with the leader of the study, Doug Mann MD or the research coordinator, Kim Faurot, PA. Dr. Mann is a neurologist and Attending Physician in the Headache clinic at UNC and will be responsible for your safety in the study. At the first meeting, you will fill out questionnaires and review consent forms. Dr. Mann will review your medical records to find out if you should participate. For the next 4 weeks, you will fill out a daily headache diary. At the end of 4 weeks, the researchers will review your diary with you and let you know if you qualify for the study. After another 4 weeks of keeping a diary, your therapy (either craniosacral for 8 weeks or magnet therapy for 8 weeks) will be chosen for you randomly by a computer program. You will fill out another questionnaire at 16 and 20 weeks. Next you meet with the therapist, Laurel Wilkinson, RN, LMBT, to have your previously selected therapy one hour each week for 8 weeks. At the end, you will have a follow-up phone call with both Dr. Mann and the survey specialist.
Are there any reasons i should not be in this study?
You should not be in this study if you are unable to keep a daily headache diary. In addition, you should not participate if you are pregnant or you have one of the following disorders:
(1) severe mental or physical illness;
(2) a blood clotting disorder;
(3) an implanted/attached electronic device, such as a pacemaker/insulin pump; or
(4) a recent history of head or neck injury/surgery.
What are the possible benefits?
Research is designed to benefit society by gaining new knowledge. Being in this study may reduce your migraine symptoms or improve your ability to function. However, there is no guarantee that you will receive any benefit.
What are the possible risks?
Risks associated with craniosacral therapy or magnets are minimal; there is no evidence that either one will worsen your headaches. However, the following may occur:
- transient sleepiness, lasting minutes to up to a day;
- transient light-headedness, lasting a few minutes.
In addition, emotions may arise during your therapy. You may discuss your feelings with the therapist.
Sharing personal information is entirely up to you—it is never required.
Will i be paid?
To compensate you for your time, you will be receiving $5 for each week of headache diaries you fill out and $15-25 each time you fill out a set of questionnaires, for a total of $150 (if you complete the entire study). If needed, parking vouchers will also be provided.
Will it cost me anything to be in this study?
It will not cost you anything in addition to be in the study.
Funded by NIH R21 AT002750-01A2
This flyer was approved by the University of North Carolina Biomedical Institutional Review Board for use from
10/17/06 to 9/17/07 |
