Effect of electroacupuncture to GB44, TE21, ST36 and LR2 on pain and disability in migraineurs: A randomised placebo - controlled trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Migraine Disability Assessment (MIDAS) Questionnaire
Study Overview
Brief Summary
A randomized placebo- controlled trial will be adopted for the study. 50 patients will be recruited from Government Yoga and Naturopathy Medical College and Hospital and randomly divided into study and control group. The baseline assessments such as Migraine disability assessment (MIDAS) questionnaire as a primary outcome measure and Electroencephalogram (EEG) as a secondary outcome measure will be recorded for both the groups. For study group electroacupuncture will be given to four acupuncture points (GB44, TE21, ST36 and LR2) and in control group electroacupuncture will be given at four non-acupuncture points. Electrical stimulus to acupuncture and non- acupuncture points will be given using acupoint nerve stimulator (ACS acupressure stimulator TENS – 2 channel) with intermittent wave, frequency of 5Hz, current intensity adjusted according to patients’ tolerance with needle retention for 30 mins for 5 days per week for a total duration of 2 weeks. Post assessment will be taken after 2 weeks of intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients who confirm the diagnostic criteria for migraine stipulated by The International Classification of Headache Disorders, 3rd edition 2) Patients of Migraine with aura (MwA) and Migraine without aura (MwoA) 3) Patients not under drugs for migraine prophylaxis 4) Patients willing to take part in research and give written informed consent.
Exclusion Criteria
- •Other primary and secondary types of headaches 2) Cerebral hemorrhage and vascular malformation 3) Stroke 4) Parkinson’s and other extrapyramidal diseases 5) History of epilepsy or any mental disorders 6) Intake of anti-psychotic or anti-depressant drugs 7) Neuralgia of face or head 8) Pregnancy, lactation or insufficient contraception 9) Immunodeficiency and bleeding disorders 10) Severe pain syndromes of cervical spine 11) Serious illness such as cancer 12) Patients with metal implants, pacemaker or prosthetics 13) Phobia to needling and electrical stimulation 14) Participation in any other clinical trial.
Outcomes
Primary Outcomes
Migraine Disability Assessment (MIDAS) Questionnaire
Time Frame: Migraine Disability Assessment (MIDAS) Questionnaire will be measured before and after 2 weeks of intervention
Secondary Outcomes
- Electroencephalogram (EEG)(The changes in various frequency bands (alpha, beta, theta and delta) of cortical activity will be measured using EEG before and after 2 weeks of intervention)
Investigators
Dr N Sheeja Begum
Government Yoga and Naturopathy Medical College and Hospital