| CTRI Number |
CTRI/2025/05/086427 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Myofascial Release and Cupping Therapy on Neck-Related Headaches in Adults |
|
Scientific Title of Study
|
Comparing The Effect Of Suboccipital Myofascial Release And Remote Release By Dynamic Cupping On Cervicogenic Headache |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Trishala rangare |
| Designation |
MPT student |
| Affiliation |
Maharishi Markandeshwar institute of physiotherapy and rehabilitation |
| Address |
Room no. 02, biomechanics lab, Maharishi Markandeshwar Institute of
Physiotherapy and rehabilitation Maharishi Markandeshwar deemed
to be university.
Ambala
HARYANA
133207
India |
| Phone |
09399166026 |
| Fax |
|
| Email |
tr4306@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Popli Jivani PT |
| Designation |
Assistant professor |
| Affiliation |
Maharishi Markandeshwar institute of physiotherapy and rehabilitation |
| Address |
Address Room NO 02,Biomechanics lab, Maharishi Markandeshwar institute of
physiotherapy and rehabilitation Maharishi Markandeshwar deemed
to be university.
Ambala
HARYANA
133207
India |
| Phone |
9896461613 |
| Fax |
|
| Email |
aditi.popli.freebird@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Popli Jivani PT |
| Designation |
Assistant professor |
| Affiliation |
Maharishi Markandeshwar institute of physiotherapy and rehabilitation |
| Address |
Room NO.02,Biomechanics lab, Maharishi Markandeshwar institute of
physiotherapy and rehabilitation Maharishi Markandeshwar deemed
to be university.
Ambala
HARYANA
133207
India |
| Phone |
9896461613 |
| Fax |
|
| Email |
aditi.popli.freebird@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar deemed
to be university,mullana, Ambala Haryana 133203 |
|
|
Primary Sponsor
|
| Name |
Trishala Rangare |
| Address |
Maharishi Markandeshwar institute of physiotherapy and
rehabilitation Maharishi Markandeshwar deemed to be university |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Aditi popli |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Room no 02,biomechanic lab,Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation Ambala HARYANA
Ambala
HARYANA |
9896461613
aditi.popli.freebird@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeshwar Institute of Medical Science and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M25||Other joint disorder, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dynamic cupping |
remote release by dynamic cupping on the thoracolumbar fascia |
| Intervention |
suboccipital myofascial release and dynamic cupping |
para spinal muscles will be involved |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with cervicogenic headache of 20 to 30 years of age both male and female, Individuals with Cervicogenic Headache as diagnosed by International Classification of Headache (ICH) and Individuals with unilateral head pain in occipital and upper posterior neck region. |
|
| ExclusionCriteria |
| Details |
Individuals with cervicogenic headache of 20 to 30 years of age both male and female, Individuals with Cervicogenic Headache as diagnosed by International Classification of Headache (ICH) and Individuals with unilateral head pain in occipital and upper posterior neck region. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale (NPRS)
Neck disability index
Headache impact test-6
Inclinometer |
Baseline, 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
This study investigates the comparative and combined effects of Myofascial Release (MFR) and Cupping Therapy on adults suffering from neck-related headaches, often associated with cervicogenic or tension-type origins. The research aims to assess improvements in headache intensity, frequency, cervical range of motion, and overall quality of life. Participants were divided into groups receiving MFR, cupping therapy, or a combination of both. Results indicate that both therapies significantly reduce headache symptoms, with the combined approach yielding superior outcomes in pain relief and functional improvement. These findings support the integration of manual therapies in the conservative management of neck-related headaches. |