| CTRI Number |
CTRI/2025/12/098426 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| 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
|
to compare two different type of exercise protocols to treat chronic lumbo-pelvic pain in obese postmenopausal women |
|
Scientific Title of Study
|
Comparative Evaluation of Lumbopelvic and Dynamic Neuromuscular Stabilisation Exercises on Chronic Lumbopelvic Pain and Asymmetry in Obese Postmenopausal women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sadaf Khan |
| Designation |
Research Scholar |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Q Block, QS 11 Department of Physiotherapy Manav Rachna International Institute of Research and Studies Sect-43 Aravalli Hills. Faridabad HARYANA 121004 India
Faridabad
HARYANA
121004
India |
| Phone |
8755576085 |
| Fax |
|
| Email |
sadafmpt2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasmine Kaur Chawla |
| Designation |
Associate Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Q block, room no QS-06, Physiotherapy Department MRIIRS Aravalli Campus, Sector-43, Delhi-Surajkund, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9888263685 |
| Fax |
|
| Email |
jasminekaur.sahs@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasmine Kaur Chawla |
| Designation |
Associate Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Q block, room no QS-06, Physiotherapy Department MRIIRS Aravalli Campus, Sector-43, Delhi-Surajkund, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
09888263685 |
| Fax |
|
| Email |
jasminekaur.sahs@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International Institute of Research and Studies |
|
|
Primary Sponsor
|
| Name |
Manav Rachna International Institute of Research and Studies |
| Address |
MRIIRS Aravalli Campus, Sector-43, Delhi-Surajkund, Faridabad |
| 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 |
| DR JASMINE KAUR CHAWLA |
Performance Lab,Manav Rachna International Institute of Research and Studies |
Performance lab, Department of Physiotherapy, J block, Room no 3, MRIIRS, Faridabad, Haryana
Faridabad
HARYANA |
9888263685
jasmine.k.chawla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITEE, MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Lumbopelvic Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
general guidelines for lifestyle modification |
| Intervention |
Dynamic neuromuscular stabilisation exercises |
8 weeks of intervention protocol of Dynamic neuromuscular stabilization exercises on the postmenopausal women having lumbopelvic pain |
| Intervention |
Lumbopelvic stabilization exercises |
8 weeks of intervention protocol of Lumbopelvic stabilization exercises on the postmenopausal women having lumbopelvic pain |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Women who did not have menses for more than one year and have lumbopelvic pain for more than 3 months. |
|
| ExclusionCriteria |
| Details |
Pain due to any other musculoskeletal or metabolic ailment, any spinal deformity or spinal pathology, any fracture or injury, or any surgery. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| lumbopelvic pain, pelvic assymetry and body mass index |
at 0 week baseline readings - lumbo pelvic pain, BMI and pelvic asymmetry using pelvic inclinometer will be assessed.
at 8 week post intervention - lumbo pelvic pain, BMI and pelvic asymmetry using pelvic inclinometer will be assessed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect on Muscle strength, Disability, Fear avoidance Beliefs and Menopausal Quality of life |
Pre-reading and post-assessment reading will be done after 8 weeks of intervention exercise protocols |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
15/12/2025 |
| 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="0"
Months="2"
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
|
Postmenopausal women suffering from lumbopelvic pain will be recruited according to the inclusion and exclusion criteria. The sample will be divided into three groups: one group will perform DNS, another will perform LPSE, and the third will serve as a control group receiving lifestyle modifications for managing lumbopelvic pain. Pre- and post-assessments will be conducted following the 8-week intervention protocol to find the individual effect and compare the effect for management of lumbopelvic pain
|