Migraine Disorders Clinical Trial
Official title:
Continue or Stop Applying Wet Cupping (Al-Hijamah) in Migraine Headache: A Randomized Control Trial
This study evaluates the short and long-term effects of application of Wet Cupping Therapy (WCT) in the treatment of migraine headaches in adults.Half of the participants will continue WCT application and the other half will not.
In literature, Cupping therapy(CT) has been shown to be used mostly for pain control and the
majority of RCT studies have shown that CT has potential benefits in pain conditions.
Previous studies have reported the effect of pain mediator substance-P, endorphins,
encephalins and dynorphins on pain(1) In addition to pain control, it is recommended for use
as additional treatment in neurological diseases such as paralysis, Parkinson's disease and
stroke Studies have shown successful results in the short term with the application of CT for
migraine and tension-type headaches (2,3) Methodology Study design and Patient selection
Patients with a history of migraine diagnosis who presented at the Research Polyclinic of
Karabuk University Training and Research Hospital for wet-cupping therapy in the period May
2016-January 2018 were included in the study. Patients were excluded if they had a history of
head and neck surgery, a diagnosis of sinusitis, a diagnosis of fibromyalgia and inflammatory
disease (rheumatism, infection etc.), were pregnant, had a diagnosis of cancer, bleeding
disorder and widespread skin disease, malignant hypertension or any other disease which could
cause headache. The diagnosis of migraine was confirmed by an experienced neurologist and the
migraine type was determined. The medical treatments of the patients were reviewed and MIDAS
was applied to determine the baseline score. In addition to the medical treatment, WCT was
applied once a month, 3 times (Day 0, 30, 60). At the end of the 3rd month patients were
allocated into two parallel arms. They were randomly assigned to the intervention group or
control group in a double blind manner by the sealed opaque envelope technique. Intervention
group continued WCT whereas patients in the control group discontinued the treatment. MIDAS
was applied again at the end of the 6th and 12th months to both of the groups. Disability
values in the 6th and 12th months were evaluated with MIDAS between those who continued
treatment (Group 1) and those who did not (Group 2). Approval for the study was granted by
Turgut Ozal University Ethics Committee, with number 99950669/236, dated 30.06.2014.Study
design, application procedures and any possible side effects were explained to the study
participants and informed consents obtained. All procedures performed in studies involving
human participants were in accordance with the ethical standards of the institutional and/or
national research committee and with the 1964 Helsinki declaration and its later amendments
or comparable ethical standards.
MIDAS The migraine disability score is a scale evaluating disability and loss associated with
migraine. It consists of 7 questions, the 1st, 3rd and 5th of which evaluate the days lost
from school, work, housework or leisure activities because of headaches in the last 3 months.
The 2nd and 4th questions evaluate the number of additional days lost from work or housework
in the last 3 months due to a reduction in productivity (defined as at least a 50% reduction
in productivity). An additional two questions (MIDAS A and B) evaluate the frequency of
headaches and the severity of the headaches using a visual analog scale (VAS), but these are
not added to the total MIDAS score. The total MIDAS points are obtained from the total of the
first 5 questions. Total points of 0-5 = 1st degree (very little or no restriction), 6-10
points =2nd degree (mild or occasional restriction), 11-20 points = 3rd degree (moderate
level of restriction), and 21 + points = 4th degree (severe restriction).
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