| CTRI Number |
CTRI/2023/02/049597 [Registered on: 09/02/2023] Trial Registered Prospectively |
| Last Modified On: |
08/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
myofascial release and stretching exercise on outcome measures of migraine in college going students. |
|
Scientific Title of Study
|
A comparative study of myofascial release and stretching technique on clinical outcomes of migraine in college going students. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanushree K Patil |
| Designation |
UG |
| Affiliation |
Pravara institute of medical sciences |
| Address |
Pravara institute of medical sciences Loni.
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8459192530 |
| Fax |
|
| Email |
patiltanushree2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ketaki Patani |
| Designation |
Associate Professor |
| Affiliation |
Pravara institute of medical sciences |
| Address |
Pravara institute of medical sciences Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9168022254 |
| Fax |
|
| Email |
ketu6731@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanushree K Patil |
| Designation |
UG |
| Affiliation |
Pravara institute of medical sciences |
| Address |
Pravara institute of medical sciences Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8459192530 |
| Fax |
|
| Email |
patiltanushree2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pravara institute of medical sciences.
Medicine department
Physiotherapy department |
|
|
Primary Sponsor
|
| Name |
SELF |
| Address |
Pravara institute of medical sciences Loni Tal Rahata Dist Ahmadnagar Maharashtra |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ketaki Patani |
PMt staff quarter 525/5/41
Loni. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Tanushree K Patil |
Pravara Institute Of Medical Sciences |
rural dental college , physiotherapy department tal Rahat dist Ahmadnagar Maharashtra.
Ahmadnagar
MAHARASHTRA |
8459192530
patiltanushree2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pravara institute of medical sciences loni |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Myofascial release
Stretching |
20 mins duration for 2 weeks 3 days per week |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Participants from rural medical college rural dental college and dr. apj abdul kalam college of physiotherapy.
Participants with diagnosis of migraine headache according to ihs criteria by a neurologist. |
|
| ExclusionCriteria |
| Details |
Participants with history of neck trauma.
Participants with cervical radiculopathy.
Participants who previously had surgery in neck or shoulder.
Participants who received trigger point therapy in the neck within the previous 6 months.
Participants with other orthopedic conditions associated with cervical spine and shoulder. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The pain intensity will be recorded on a reliable visual analog scale (VAS)
The CROM was measured by a reliable clinical goniometer
The Migraine Disability Assessment Test (MIDAS)
|
At baseline and after 2 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/02/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Migraine is a very common neurobiological headache disorder
and present with active trigger points in the neck muscles which when released
may decrease the pain intensity during the attack and reduce the analgesic
intake in students therefore the study is conducted in 2 groups with one group
having myofascial release with stretching and the second group will receive only stretching and the effectiveness will be examined at the end of 2 weeks
intervention. |