| CTRI Number |
CTRI/2025/08/092607 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Gender Differences in Physiotherapy for Muscle and Joint Problems |
|
Scientific Title of Study
|
Advancing Gender Equity in Musculoskeletal Physiotherapy by Addressing Gender-Specific Needs and Research Representation: A Retrospective Cohort Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohammad Sidiq |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B319, Department of Physiotherapy, School of Allied Health Sciences, Plot No 2, Sector 17A, Opposite Buddha International Cicruit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
6006204628 |
| Fax |
|
| Email |
sidufatima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammad Sidiq |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B319, Department of Physiotherapy, School of Allied Health Sciences, Plot No 2, Sector 17A, Opposite Buddha International Cicruit, Greater Noida
UTTAR PRADESH
203201
India |
| Phone |
6006204628 |
| Fax |
|
| Email |
sidufatima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aksh Chahal |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B316, Department of Physiotherapy, School of Allied Health Sciences, Plot No 2, Sector 17A, Opposite Buddha International Cicruit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9711774174 |
| Fax |
|
| Email |
drakshchahal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Galgotias Multidisciplinary Research and Development Cell |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No 2, Sector 17A, Opposite Buddha International Circuit, Gautam Buddha Nagar, Uttar Pradesh, India, 203201 |
| Type of Sponsor |
Research institution |
|
|
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 Mohammad Sidiq |
Galgotias University |
Room No E003, Department of Physiotherapy, School of Allied Health Sciences, Plot No 2, Sector 17A, Opposite Buddha International Circuit,
Gautam Buddha Nagar
UTTAR PRADESH |
6006204628
sidufatima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scool Ethics Committee Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M798||Other specified soft tissue disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with musculoskeletal conditions (e.g., low back pain, osteoarthritis, neck pain, and tendinopathies).
2.Received physiotherapy treatment in the institution during the defined study period (e.g., January 2019 – December 2023).
3. Complete medical and physiotherapy records available, including gender/sex identification, treatment protocols, and outcome measures.
|
|
| ExclusionCriteria |
| Details |
1.Patients with systemic conditions (e.g., rheumatoid arthritis, cancer, or neurological disorders) affecting musculoskeletal health.
2.Incomplete or missing physiotherapy documentation or unclear gender identification in records.
3.Patients who received surgical treatment for MSK conditions during the period (if you want to focus on non-surgical management).
4.Pregnant females (due to unique MSK demands and clinical pathway).
5.Pediatric or geriatric patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
NPRS (Numerical Pain Rating Scale)
Oswestry Disability Index (ODI) – for low back pain
WOMAC – for osteoarthritis
Neck Disability Index (NDI) – for neck pain
SPADI |
At Baseline (T0)
At End of PT (T1)
Follow Up of PT (T2) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "323"
Final Enrollment numbers achieved (India)="323" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/09/2025 |
| Date of Study Completion (India) |
12/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
This retrospective cohort study aims to investigate gender-specific needs, treatment patterns, and outcomes among patients receiving physiotherapy for musculoskeletal (MSK) conditions. By analyzing clinical records from January 2019 to December 2023, the study seeks to identify disparities in access, intervention strategies, and functional outcomes between male and female patients. Outcome measures such as pain intensity (NPRS/VAS), functional status (ODI, WOMAC, NDI), SPADI, and quality of life (SF-36) will be evaluated at baseline and post-treatment timepoints. The study also explores gender representation in physiotherapy utilization and adherence to treatment protocols. A minimum sample size of 128 patients has been estimated, although all eligible records within the timeframe will be included to strengthen statistical power. The findings aim to highlight gaps in gender equity and inform physiotherapy practice and policy, promoting inclusive, evidence-based care tailored to gender-specific MSK health needs. |