| CTRI Number |
CTRI/2017/03/008087 [Registered on: 14/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
06/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to determine the comparative efficacy of manual physiotherapy over standard drug therapy in patients suffering from migraine. |
|
Scientific Title of Study
|
Effectiveness of cervical mobilization and conventional drug therapy in migraine patients: A comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Frieda P Engheepi |
| Designation |
Research Scholar |
| Affiliation |
Sikkim Manipal University |
| Address |
Sikkim Manipal College of Physiotherapy
5th mile,Tadong
Gangtok
East
SIKKIM
737102
India |
| Phone |
09933488004 |
| Fax |
|
| Email |
friedapphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikita Joshi Sonowal PT |
| Designation |
Professor |
| Affiliation |
Sikkim Manipal University |
| Address |
Sikkim Manipal College of Physiotherapy
5th mile,Tadong
Gangtok
East
SIKKIM
737102
India |
| Phone |
09932470754 |
| Fax |
|
| Email |
nikitajosse@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Frieda P Engheepi |
| Designation |
Research Scholar |
| Affiliation |
Sikkim Manipal University |
| Address |
Sikkim Manipal College of Physiotherapy
5th mile,Tadong
Gangtok
East
SIKKIM
737102
India |
| Phone |
09933488004 |
| Fax |
|
| Email |
friedapphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PHYSIOTHERAPY AND DEPARTMENT OF MEDICINE
CENTRAL REFERRAL HOSPITAL
SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES
5TH MILE TADONG
GANGTOK SIKKIM |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Parvati Nandy |
SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCED |
Central Referral Hospital
Department of Medicine and Department of Physiotherapy
East
SIKKIM |
09434631747
drparvaty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS INSTITUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Newly diagnosed migraine patient according to ICHD(International Classification of Headache Disorders)criteria., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cervical mobilization technique given by the physiotherapist (Principle investigator) |
•Patients were instructed to lie in prone position on the mobilization bed. The cervical area should be exposed properly and all the jewelries should be removed. Patients should wear comfortable clothing. Patient lies face downwards with his forehead resting on the backs of his fingers or palms, with a moderate degree of ‘chin-in’ position to lessen the cervical lordosis slightly.
•The therapist stands in stride position infront of the patient’s head. The cervical vertebrae were palpated individually according to Maitland’s palpation method.13 The oscillatory movement is produced through the physiotherapist’s arms and body, while her hands are kept stable with an evenly distributed pressure around the patient’s neck. It is important that the neck and hands move as a single unit.
•Grades of mobilization given were according to the patient’s examination findings of hypo mobility and so it differed from patient to patient.
•The treatment dosage given were one oscillation per second for ten seconds through all the cervical vertebrae. The total treatment duration was for 10 minutes.
It was given for 3 times per week for 3 weeks
|
| Comparator Agent |
drug therapy prescribed by the physician |
Flunarizine 10 mg daily for three weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Newly diagnosed migraine patients according to International Classification of Headache Disorders Criteria
2.Patient who are able to attend three weeks of treatment |
|
| ExclusionCriteria |
| Details |
1.Marked depression, anxiety or psychosis
2.More than 2 visits/month for other health care related problems
3.Major medical illness under treatment
4.Other cause of secondary headache
1)Systemic infection
2)Vascular disorder
3)Subarachnoid Hemorrhage
4)Brain tumor
5.Pregnancy
6.Head or neck trauma in past 2 years
7.Cranial/neck surgery in past 2 years
8.Cardiac Pacemaker
9.Other implanted or external electrical device (e.g. insulin pump)
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Headache Impact Test, Migraine Disability Assessment Test |
3 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After screening the subjects, the patients were randomized into conventional drug therapy and cervical mobilization group. The outcome of this study will help in reduction of episodes of migraine in terms of reduced frequency and severity of headache or headache related disability in migraine patients.Results showed that there are statistically significant difference present between group analysis for Headache Impact Test-6(HIT-6)outcome measure in the follow up period and also within group analysis had statistically significant differences for both the groups but clinical significance was more in the cervical mobilization group showing effectiveness in terms of reduced headache frequency,disability and intensity.
|