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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  
Nil 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Outcome  TimePoints 
NIL   
 
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
 
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