| CTRI Number |
CTRI/2026/01/100004 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pelvic Muscle Release Technique to Reduce Pelvic Pain in Endometriosis |
|
Scientific Title of Study
|
Effectiveness Of Pelvic Diaphragm Release Technique On Pelvic Pain And Quality Of Life In Endometriosis Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Godisela Sahana |
| Designation |
Postgraduate Student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
Faculty OF Physiotherapy,
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Tamil Nadu, India.
Faculty Of Physiotherapy,
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9398794600 |
| Fax |
|
| Email |
godiselasahana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MS PPonmathi |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research
Faculty Of Physiotherapy,
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Tamil Nadu, India.
Faculty Of Physiotherapy,
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9787211229 |
| Fax |
|
| Email |
ponmathi.p@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
MS PPonmathi |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Faculty Of Physiotherapy,
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Tamil Nadu, India.
Faculty Of Physiotherapy,
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
09787211229 |
| Fax |
|
| Email |
ponmathi.p@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education And Research |
|
|
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 |
| DrPPonmathi |
Department Of Obstetrics and Gynecology, Sri Ramachandra Hospital, room no.4,1st floor,G-block |
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Tamil Nadu, India.
Chennai
TAMIL NADU |
9787211229
ponmathi.p@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N738||Other specified female pelvic inflammatory diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pelvic Diaphragm Release Technique |
Pelvic Diaphragm Release Technique: The patient was in a supine position. One hand was placed under the lumbosacral junction and the other hand on the upper surface of the pelvic area, perpendicular to the one below. A slight compression was performed for 5 min to produce a relaxation in the fascial tissue for 3 weeks . |
| Comparator Agent |
pelvic floor muscle relaxation exercises |
pelvic floor muscle relaxation: a different type of pelvic floor stretching exercises and positions for 30 seconds overall duration for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Female participants between the ages of 20 and 45 years.
2.Endometriosis diagnosis established either through clinical evaluation or laparoscopic confirmation or MRI diagnosed.
3.A history of persistent pelvic pain lasting 6 months.
4.Baseline pain intensity of at least 4/10 on the Visual Analogue Scale (VAS).
5.Ability to understand the study, Commitment to attend scheduled therapy sessions throughout the study period and provide voluntary written consent
|
|
| ExclusionCriteria |
| Details |
1.Women who are currently pregnant or have been pregnant in the preceding 6 months.
2.Those who have undergone recent pelvic or abdominal surgery (within the last 6 months).
3.Participants with neurological impairments influencing pelvic floor function (e.g., spinal cord injury, multiple sclerosis).
4.Presence of active pelvic infections such as pelvic inflammatory disease, urinary tract infection, or genital infection.
5.Individuals on medications that alter muscle tone or pain perception (e.g., opioids, muscle relaxants).
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NPRS-Scale For Evaluation Of Pelvic Pain and intensity of the pain. |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EHP-5 For Evaluation Of Quality Of Life In Endometriosis Patients |
6 Months |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
12/01/2026 |
| 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="15" |
|
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
|
Endometriosis Affects Approximately 10 Percent Of Women Of Reproductive Age Globally, And characterized By The Ectopic Endometrial Tissue Leading To Chronic Pelvic Pain, And Reduce Quality Of Life. Studies Indicate That Pelvic Floor Muscles Dysfunction, Particularly, Pelvic Diaphragm Hypertonicity and Trigger PointsContributes Significantly Persistent Pain In The Endometriosis Patients. Pelvic Diaphragm Release, A Manual Therapy Technique Targeting Pelvic Floor Muscles Has Show Effect On Allevating Pain And Improving Quality Of Life. However, Their Is A Limited Evidence Focusing Specifically On Its Isolated Effects In The Endometriosis . This Study Is Designed To Evaluate The Effectiveness Of Pelvic Diaphragm Release On Pelvic Pain And Quality Of Life In Women With Endometriosis, Aiming To Inform Evidence Based, Non-invasive Therapeutic stratergie. |