| CTRI Number |
CTRI/2025/07/090843 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Physiotherapy in irregular menstruation |
|
Scientific Title of Study
|
Effect of Myofascial Release on Pain and Health Related Quality of Life in Women with Irregular Menstrual Cycle |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pakeeza Altaf |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no 2, Ground floor department of physiotherapy,Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University
Ambala
HARYANA
133207
India |
| Phone |
7006434851 |
| Fax |
|
| Email |
pakeezaaltaf999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu Goyal |
| Designation |
Principal and Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no 7, Ground floor department of physiotherapy ,Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University
Ambala
HARYANA
133207
India |
| Phone |
8307715320 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manu Goyal |
| Designation |
Principal and Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no 7, Ground floor department of physiotherapy ,Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University
HARYANA
133207
India |
| Phone |
8307715320 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Pakeeza Altaf, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala,Haryana |
|
|
Primary Sponsor
|
| Name |
Pakeeza Altaf |
| Address |
Room no 2, Ground floor department of physiotherapy,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 |
| DrPakeeza Altaf |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Room no 2, Ground floor department of physiotherapy,Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University
Ambala
HARYANA |
7006434851
pakeezaaltaf999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL MAHARISHI MARKANDESHWAR INSTITUTE OF MEDICAL SCIENCES & RESEARCH MULLANA, AMBALA Communication of Decision of the Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N915||Oligomenorrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hot pack + Myofascial Release+ IFT |
A total of 12 sessions will be given to the individuals. Hot pack will be given for 10 minutes; the myofascial release will be applied for 30 minutes and IFT will be given for 15 minutes. |
| Comparator Agent |
Sham Hot pack + Myofascial Release +IFT |
this group will recieve sham hotpack for 10 minutes, followed by myofascial release for 30 minutes and IFT for 15 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Female participant
Typically, between 18 to 45 years
Diagnosed with irregular menstrual cycle
Experience of menstrual related pain or pelvic pain
Ability to commit to the study duration and procedures |
|
| ExclusionCriteria |
| Details |
Any severe underlying conditions
Recent use of hormonal therapies or surgical interventions related to menstrual cycles
Pre-existing conditions affecting the musculoskeletal system that may interfere with myofascial release treatment
Mental health issues that might affect participation or reporting of outcomes
Pregnant or breastfeeding women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Numeric Pain Rating Scale |
Baseline and at the end of 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
25/07/2025 |
| 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 Yet Recruiting |
| 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 aims to investigate the impact of myofascial release (MFR) therapy on pain and overall health-related quality of life (HRQoL) in women experiencing irregular menstrual cycles. Irregular menstruation is often associated with dysmenorrhea (painful menstruation), mood disturbances, and other symptoms that negatively affect daily functioning and quality of life. Myofascial release, a manual therapy technique that targets muscle tension and fascia, has shown potential in alleviating pain and improving mobility. This study will assess whether MFR can reduce menstrual pain, enhance physical and emotional well-being, and improve general quality of life in women with irregular cycles. The outcomes will be measured through pain intensity scales and HRQoL assessments, including physical, mental, and emotional health components. |