| CTRI Number |
CTRI/2023/11/059436 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the effects of wet cupping and taping on people with swelling of neck muscles caused due to migraine |
|
Scientific Title of Study
|
Comparative Effect of Wet Cupping and Rigid Taping on Individuals with Migraine Induced Trapezitis: A Randomised Clinical 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 |
Pooja Dusane |
| Designation |
Post Graduate Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD number 39, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590001
India |
| Phone |
9082897956 |
| Fax |
|
| Email |
dusane.poooja2799@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kage |
| Designation |
Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD number 39, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590001
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kage |
| Designation |
Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD number 39, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590001
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research Nehru Nagar Belgaum |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
Nehru Nagar Belgaum |
| Type of Sponsor |
Private 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 Vijay Kage |
KLEs Dr Prabhakar Kore Hospital and Medical Research Centre |
Department of Orthopedic Physiotherapy, OPD number 39, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA |
9845271899
vijaykage@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Rigid Taping and conventional treatment |
Rigid Taping and conventional treatment will be given for 2 weeks and 3 times per week |
| Intervention |
Wet Cupping and conventional treatment |
Wet cupping and conventional treatment will be given for 2 weeks and 3 times per week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate
Age between 18 and 50 years
Intensity of 3 points and more on the Numerical Pain Rating Scale.
Clinically diagnosed with migraine induced trapezitis.
|
|
| ExclusionCriteria |
| Details |
any history of muscular or neurological disorders (except for migraine)
Pregnancy, Diabetes Mellitus
History of allergy to tape, open wounds
Hypersensitive skin
Any skin allergy
Any contraindication to use cupping.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Headache Impact Test (HIT-6)
Migraine disability assessment (MIDAS) questionnaire
Range of Motion using Universal Goniometer
Numerical Pain Rating Scale (NPRS)
Pain Pressure Threshold
|
pre - at baseline
post - after 2 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
08/11/2023 |
| Date of Study Completion (India) |
28/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Aim: To
determine the effect of wet cupping and rigid taping in
individuals with migraine induced trapezitis. Inclusion Criteria: Willing
to participate, Age
between 18 and 50 years, Intensity
of 3 points and more on the Numerical Pain Rating Scale., Clinically
diagnosed with migraine induced trapezitis. Exclusion Criteria: Any
history of muscular or neurological disorders (except for migraine), Pregnancy,
Diabetes Mellitus, History
of allergy to tape, open wounds, Hypersensitive
skin, Any skin allergy, Any
contraindication to use cupping. Ou Outcome Measure: Headache Impact Test (HIT-6), Migraine
disability assessment (MIDAS) questionnaire, Range
of Motion using Universal Goniometer, Numerical
Pain Rating Scale (NPRS), Pain
Pressure Threshold Procedure: GROUP A will be given wet cupping and conventional treatment and Group B will be given rigid taping and conventional treatment this will last for 2 weeks with thrice per week.
|