| CTRI Number |
CTRI/2026/02/104054 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How shoulder movement,pain and function are affected after breast removal surgery in breast cancer patients |
|
Scientific Title of Study
|
Correlation of Scapular motion, Shoulder Pain and Proprioceptive Accuracy with Upper Limb Disability in Modified Radical Mastectomy patients - A Cross-Sectional 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 Shraddha Shinde PT |
| Designation |
MPT |
| Affiliation |
MAEERs Physiotherapy College |
| Address |
A207, Musculoskeletal Physiotherapy Department, MAEERs Physiotherapy College, Talegaon railway station road, Talegaon Dabhade, Pune
Pune MAHARASHTRA 411507 India |
| Phone |
8010264881 |
| Fax |
|
| Email |
shraddha.shinde0404@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Neetu Mahapatra |
| Designation |
Professor |
| Affiliation |
MAEERs Physiotherapy College |
| Address |
Cabin A221, Musculoskeletal Physiotherapy Department, MAEERs Physiotherapy College, Talegaon railway station road, Talegaon Dabhade, Pune
Pune MAHARASHTRA 411507 India |
| Phone |
9823236752 |
| Fax |
|
| Email |
neetu@mitmimer.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Neetu Mahapatra |
| Designation |
Professor |
| Affiliation |
MAEERs Physiotherapy College |
| Address |
Cabin A221, Musculoskeletal Physiotherapy Department, MAEERs Physiotherapy College, Talegaon railway station road, Talegaon Dabhade, Pune
Pune MAHARASHTRA 411507 India |
| Phone |
9823236752 |
| Fax |
|
| Email |
neetu@mitmimer.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MAEERs Physiotherapy College |
| Address |
A207, Musculoskeletal Physiotherapy Department, MAEERs Physiotherapy College, Talegaon railway station road, Talegaon Dabhade, Pune |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Shraddha Shinde |
Bhausaheb Sardesai Talegaon Rural Hospital, Talegaon Dabhade |
Bhausaheb Sardesai Talegaon Rural Hospital,near Talegaon railway station, Talegaon Dabhade, Pune - 411507 Pune MAHARASHTRA |
8010264881
shraddha.shinde0404@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAEERs Physiotherapy College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Female |
| Details |
Female patients who have undergone modified radical mastectomy(MRM)
Post-operative period of 4 weeks – 1 year
Unilateral MRM cases
Patients currently undergoing or having completed radiation therapy |
|
| ExclusionCriteria |
| Details |
1. Patients with Lymphoedema.
2. History of pre-existing shoulder injuries and disorders in last 6 months
3. Any known neurological disorders affecting upper limb function
4.Any known psychiatric or cognitive impairments that prevent proper participation in assessments |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shoulder Proprioception – Active Joint Position Sense Test using Digital Inclinometer
Scapular Motion – Digital Inclinometer
Pain – Numerical Pain Rating Scale (NPRS)
Upper limb Disability – Disability of Arm, Shoulder and Hand (DASH)
|
Day 1 |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Modified Radical Mastectomy often leads to long-term shoulder complications due to surgical disruption of soft tissues, altered scapulothoracic mechanics, postoperative immobilization, and pain-related protective patterns. These changes may compromise scapular motion, reduce shoulder proprioceptive accuracy, and increase upper limb disability, affecting daily functional activities and quality of life.
This study aims to evaluate the relationship between scapular kinematics, shoulder pain, and joint position sense with upper limb disability in women who have undergone MRM. Scapular motion will be assessed using standardized clinical measures, shoulder pain will be measured using validated pain scales, proprioceptive accuracy will be tested through active joint repositioning, and upper limb disability will be quantified using a functional outcome questionnaire. By analyzing the correlations among these variables, the study seeks to identify key contributors to post-mastectomy shoulder dysfunction.
Understanding these interrelationships will help clinicians recognize early biomechanical and sensory deficits and guide targeted physiotherapy interventions. The findings may support the development of more specific rehabilitation protocols to reduce pain, improve neuromuscular control, restore scapular mechanics, and enhance functional recovery in post-MRM patients |