| CTRI Number |
CTRI/2024/11/076656 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Exercises to strengthen the shoulder and techniques to manage scars after mastectomy |
|
Scientific Title of Study
|
Investigating The Synergy of Scapular Strengthening and Scar Management Techniques on Posture and Scapulohumeral Rhythm in Women After Mastectomy: A Randomized Clinical 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 |
Shreyasi Ghatkar |
| Designation |
PG student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, department of oncology physiotherapy, OPD no 39, room no 29, Nehru nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9029020166 |
| Fax |
|
| Email |
shreyasi.ghatkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikita Pawar |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, department of oncology physiotherapy, OPD no 39, room no 29, Nehru nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9731012979 |
| Fax |
|
| Email |
nikitapawar@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Pawar |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, department of oncology physiotherapy, OPD no 39, room no 29, Nehru nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9731012979 |
| Fax |
|
| Email |
nikitapawar@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research, Nehru nagar, Belagavi, Karnataka- 590010 |
|
|
Primary Sponsor
|
| Name |
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
KAHER Institute of Physiotherapy, department of oncology physiotherapy, OPD no 39, room no 29, Nehru nagar, Belagavi, Karnataka |
| 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 |
| Dr Nikita Pawar |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre |
Department of oncology physiotherapy, OPD no 39, room no 29, Nehru nagar, Belagavi, Karnataka
Belgaum
KARNATAKA |
9731012979
nikitapawar@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D059||Unspecified type of carcinoma in situ of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cupping therapy + Scapular strengthening exercises |
Cupping therapy- The participant will be in supine lying with the arm abducted at a painâ€free range and elbow flexed to 90°. After the application of lubricant, the release will given from the coracoid end along the bulk of the muscle towards the sternal end to prepare the tissue for cupping. Followed by Vertical mobilization and Medial/Lateral mobilization around and on the scar with silicone cup for 3-4 mins will be given.
In addition- Scapular strengthening exercises will also be given.
The combined treatment will be given for 3 days a week on alternate days for 4 weeks, 12 sessions in total |
| Intervention |
Cyriax Deep Friction Massage + Scapular strengthening exercises |
Cyriax Deep Friction Massage:- The participant will be in supine lying with the arm abducted at a painâ€free range and elbow flexed to 90°. The location of the scar will be properly palpated and friction massage would be given transversely across the scar ensuring that patient’s skin and therapist’s finger move as one. total time in one session would be 10- 12 minutes depending upon the length of scar
In addition, Scapular strengthening exercises will be given.
Combined treatment will be given for 3 days a week on alternate days for 4 weeks, 12 sessions in total |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Female breast cancer survivors who:-
-Are referred for physiotherapy and belong to the age group of 18-60 years
-Who underwent mastectomy surgery before 3 months or more
-With craniovertebral angle ≤ 50°(forward head posture) OR forward shoulder angle ≥ 52° (26)
-Current lack of any scar therapy
-Are willing to participate and provide the written informed consent form
|
|
| ExclusionCriteria |
| Details |
1) Females diagnosed with metastatic cancer
2) Had any other history of shoulder injury before mastectomy surgery
3) Unhealed wounds or age of scar less than 6 weeks in the surrounding area
4) Having any trauma or disease affecting muscles and joints such as rheumatoid arthritis, skin grafting on or around the shoulder, or having any neurological dysfunction or psychiatric disorders
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Posture :Forward Shoulder Angle and Forward Head using Photographic method
Scapulohumeral Rhythm using Digital Inclinometer |
Pre treatment assessment- Baseline
Re-assessment- end of 1st,2nd,3rd,4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Scar Quality using Patient and Observer Scar Assessment Scale 0.3 (POSAS) Linear scar version
-Shoulder Pain using Shoulder Pain and Disability Index (SPADI)
-Hand Grip Strength using Hand Held Dynamometer
- Health-Related Quality of Life using Functional Assessment of Cancer Therapy - Breast (FACT-B)
|
Pre-treatment assessment- Baseline
Re-assessment- end of 2nd and 4th week |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
18/11/2024 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Investigating The Synergy Of Scapular Strengthening And Scar Management Techniques On Posture And Scapulohumeral Rhythm In Women After Mastectomy - A Randomized Clinical Trial Aim of the study:- To investigate the synergetic effect of scapular strengthening exercises and scar tissue management techniques on Posture and Scapulohumeral Rhythm in women after unilateral mastectomy Null Hypothesis H0- There will be no difference in the effect of scapular strengthening exercises and scar tissue management techniques on forward head posture, forward shoulder posture, scapulohumeral rhythm , scar quality, shoulder pain and disability, hand grip strength, HR-QOL. Alternate Hypothesis H1- There will be a difference in the effect of scapular strengthening exercises and scar tissue management techniques on forward head posture, forward shoulder posture, scapulohumeral rhythm, scar quality, Shoulder pain and disability, hand grip strength, HR-QOL. Inclusion Criteria:- Female breast cancer survivors who:- -Are referred for physiotherapy and belong to the age group of 18-60 years (6) who underwent mastectomy surgery before 3 months or more -Craniovertebral angle ≤ 50°(forward head posture) OR forward shoulder angle ≥ 52° (26) -Current lack of any scar therapy -Are willing to participate and provide the written informed consent form Exclusion criteria:-1) Females diagnosed with metastatic cancer 2)Had any other history of shoulder injury before mastectomy surgery 3)Unhealed wounds or age of scar less than 6 weeks in the surrounding area 4)Having any trauma or disease affecting muscles and joints such as rheumatoid arthritis, skin grafting on or around the shoulder or having any neurological dysfunction or psychiatric disorders Written Informed consent will be obtained from the participant. A brief demographic data will be obtained from the subjects prior to the assessment. Baseline assessment of the participants will be done before the intervention. Then the participants will be divided into two groups i.e. Group A (n=14) and Group B (n=14). Group A will be given Cyriax deep friction massage along with Scapular strengthening exercises. And group B will be given Cupping therapy along with Scapular strengthening exercises. Post-intervention data will be collected and analysed. |