| CTRI Number |
CTRI/2025/02/080150 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trail to study the effect of electroacupuncture in altering the pain related disability in patients with migraine. |
|
Scientific Title of Study
|
Effect of electroacupuncture to GB44, TE21, ST36 and LR2 on
pain and disability in migraineurs: A randomised placebo - controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Sheeja Begum |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Acupuncture and Energy Medicine,Room No 2, Second floor,
Govt Yoga and Naturopathy Medical College and Hospital PG Block,
Arumbakkam, Chennai - 600106
Tamilnadu, India
Chennai
TAMIL NADU
600106
India |
| Phone |
9095760785 |
| Fax |
|
| Email |
sheejanazir13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Mooventhan |
| Designation |
Assistant Medical Officer cum Lecturer, Department of Research |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Research, Second floor, Room no 4,
Govt Yoga and Naturopathy Medical College and Hospital PG Block,
Arumbakkam, Chennai - 600106
Tamilnadu, India
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Sheeja Begum |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Acupuncture and Energy Medicine, Second floor,Room no 2,
Govt Yoga and Naturopathy Medical College and Hospital PG Block,
Arumbakkam, Chennai - 600106
Tamilnadu, India
Chennai
TAMIL NADU
600106
India |
| Phone |
9095760785 |
| Fax |
|
| Email |
sheejanazir13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai, TamilNadu, India
Pincode- 600106 |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai - 600106 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr N Sheeja Begum |
Government Yoga and Naturopathy Medical College and Hospital |
2nd floor,Room no 2, Department of Acupuncture and Energy Medicine, Post graduate block, Arumbakkam, Chennai- 600106, Tamil Nadu
Chennai
TAMIL NADU |
9095760785
sheejanazir13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical College and Hospital, Chennai, Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G431||Migraine with aura, (2) ICD-10 Condition: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Electrical stimulation at acupuncture points |
Acupuncture needling with electrical stimulus will be given at four points GB44, TE21, ST36 and LR2 with 30 mins retention for 5 days a week for a total of 2 weeks. The stimulus will be of intermittent wave frequency of 5Hz and the intensity will be adjusted according to patients tolerance. |
| Comparator Agent |
Electrical stimulation at non-acupuncture points |
Acupuncture needling will be given at 4 non-acupuncture points with electrical stimulus and 30 mins retention for 5 days a week for a total duration of 2 weeks. The stimulus will be of intermittent wave; frequency of 5Hz and the intensity will be adjusted according to patients tolerance. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) 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 |
|
| ExclusionCriteria |
| Details |
1) 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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Migraine Disability Assessment (MIDAS) Questionnaire |
Migraine Disability Assessment (MIDAS) Questionnaire will be measured before and after 2 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |