| CTRI Number |
CTRI/2025/06/089521 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect Of 4 Weeks Of Maitland Mobilization Versus Conventional Therapy On Shoulder Range Of Motion And Pain In Adhesive Capsulitis Among Modified Radical Mastectomy Patients |
|
Scientific Title of Study
|
Effect Of 4 Weeks Of Maitland Mobilization Versus Conventional Therapy On Shoulder Range Of Motion And Pain In Adhesive Capsulitis Among Modified Radical Mastectomy Patients-A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Diksha Fathanani |
| Designation |
Post Graduate Student |
| Affiliation |
VSPM College Of Physiotherapy Nagpur |
| Address |
Musculoskeletal Department VSPMs College Of Physiotherapy
Nagpur Maharashtra
Nagpur
MAHARASHTRA
440016
India |
| Phone |
9359544719 |
| Fax |
|
| Email |
fathananirm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRKIRAN MENDHE |
| Designation |
Associate Professor |
| Affiliation |
VSPM College Of Physiotherapy Nagpur |
| Address |
Musculoskeletal Department VSPMs College Of Physiotherapy
Nagpur Maharashtra
Nagpur
MAHARASHTRA
440016
India |
| Phone |
9503173612 |
| Fax |
|
| Email |
Kjanbandhu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DRKIRAN MENDHE |
| Designation |
Associate Professor |
| Affiliation |
VSPM College Of Physiotherapy Nagpur |
| Address |
Musculoskeletal Department VSPMs College Of Physiotherapy
Nagpur Maharashtra
Nagpur
MAHARASHTRA
440016
India |
| Phone |
9503173612 |
| Fax |
|
| Email |
Kjanbandhu@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Diksha Fathanani |
| Address |
Musculoskeletal department of Vspms College Of Physiotherapy Nagpur digdoh hills,hingana road Nagpur 440016 Maharashtra India |
| 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 Nitin Wasnik |
Lata Mangeshkar Hospital Nagpur |
Surgery Department
Lata Mangeshkar Hospital digdoh hills hingana road Nagpur 440016 Maharashtra India
Nagpur
MAHARASHTRA |
9823061714
nkpsurg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPMs COLLEGE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
1. Range of motion exercise in form of codamn given for 4 weeks
2.posterior capsule stretching given for 4 weeks
3.pectoral stretching given for 4 weeks
4. Shoulder flexion with Wand active assisted give for 4 weeks
5.shoulder abduction with Wand active assisted give for 4 weeks
|
| Intervention |
Maitland mobilization technique |
1.Anterior posterior glide for glenohumeral joint given for 4 weeks
2. Posterior anterior glide for glenohumeral joint given for 4 weeks
3. Longitudinal casual glide for glenohumeral joint given for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients who underwent modified radical mastectomy
Female patients age between 40 to 60
Patients having lymphedema
Patients with adhesive capsulitis
Patients who have done radiotherapy, chemotherapy.
Patients with post-mastectomy after 12 months
Patients who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Patients with recurrent breast cancer.
History of previous breast cancer
Rotator cuff tear
Shoulder fractures
Shoulder dislocations
Neuromusculoskeletal conditions
Shoulder impingement |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Range of Motion |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Pain intensity
3. DASH Questionnaire |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/07/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This study titled as effect of 4 weeks maitland mobilization versus conventional physiotherapy on shoulder range of motion and pain adhesive capsulitis among modified radical mastectomy patients -a randomized controlled trial comprises of two groups in which one group receives maitland mobilization technique as an intervention and the other group receives conventional physiotherapy treatment in patients modified radical mastectomy.The outcome measures in this study are Range of motion, NPRS for pain intensity,DASH Questionnaire. |