| CTRI Number |
CTRI/2025/10/096468 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing Gua Sha therapy and breast massage to reduce breast pain and fullness in mothers after childbirth. |
|
Scientific Title of Study
|
Comparison of Gua Sha Technique and Therapeutic Breast Massage Technique for Treatment of Breast Engorgement in Postnatal Women 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 |
Dr Ritika Awate |
| Designation |
Physiotherapist, MPT Student |
| Affiliation |
Terna Physiotherapy College |
| Address |
Terna Physiotherapy College, Third floor, Terna Medical College Campus, Sector 12, Nerul West, Navi Mumbai, Maharashtra
Thane
MAHARASHTRA
400706
India |
| Phone |
9922882111 |
| Fax |
|
| Email |
ritikaawate123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asawari Peter |
| Designation |
Professor and HOD Community Physiotherapy Department |
| Affiliation |
Terna Physiotherapy College |
| Address |
Terna Physiotherapy College, Third floor, Terna Medical College Campus, Sector 12, Nerul West, Navi Mumbai, Maharashtra
Thane
MAHARASHTRA
400706
India |
| Phone |
9960568048 |
| Fax |
|
| Email |
asawaripeter@ternapt.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritika Awate |
| Designation |
Physiotherapist, MPT Student |
| Affiliation |
Terna Physiotherapy College |
| Address |
Terna Physiotherapy College, Third floor, Terna Medical College Campus, Sector 12, Nerul West, Navi Mumbai, Maharashtra
Thane
MAHARASHTRA
400706
India |
| Phone |
9922882111 |
| Fax |
|
| Email |
ritikaawate123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Terna Physiotherapy College,
Third floor, Terna Medical College campus, Sector 12, Nerul West, Navi Mumbai, Thane 400706, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Ritika Awate |
| Address |
Terna Physiotherapy College, Third floor, Terna Medical College campus, Sector 12, Nerul West, Navi Mumbai 400706 |
| 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 Ritika Awate |
Terna Physiotherapy College |
Community Physiotherapy department, Third floor, Terna Physiotherapy College, Terna Medical College Campus, Sector 12, Nerul West, Navi Mumbai, Maharashtra
Thane
MAHARASHTRA |
9922882111
ritikaawate123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Charitable Trusts Terna Physiotherapy College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O922||Other and unspecified disorders ofbreast associated with pregnancy and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gua Sha Technique |
The subject will be in a semi-reclined position with the breast properly
exposed for intervention while maintaining the participant’s privacy. The therapist performing the techniques will be at the bedside of the
participant, depending on the side of the breast being treated. Proper hygiene will be maintained during handling, and non-latex hand
gloves will be used accordingly. Gua-sha tool which will be used, it will be washed and cleaned before
every session. The focus will be on the engorged area and will cover each
quadrant of the breast. Gua-sha will be used on each site and will be scraped
unidirectionally from the base of the breast towards the nipple 7 times
for 2 cycles at a 30-45-degree angle. The session will last for 20 minutes. |
| Intervention |
Therapeutic Breast Massage Technique |
The subject will be in a semi-reclined position with the breast properly
exposed for intervention while maintaining the participant’s privacy. The physiotherapist performing the techniques will be at the bedside of the
participant, depending on the side of the breast being treated. Pressure of the technique would reach skin and superficial fascia levels.
Pressure will be generated from the hand arm and shoulder and not from
body weight. Proper hygiene will be maintained during handling. The therapist places her hands on the affected breast and
gently softens the areola area by stroking from the areola toward the
axilla, a type of reverse pressure softening. Gentle massages around the breast for 5 rounds. Starting from the base of the breast use of middle 3 fingers to
lightly press and massage in a circular motion. Move around to cover
the entire breast from the base ascending towards the nipple for 5
min. Will be doing these steps for 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) Postnatal lactating women
2) Able to give written informed consent
3) Having signs and symptoms of breast engorgement (pain, swelling,
firmness of the breast tissue)
4) Scoring 2 and above on the point breast engorgement scale. |
|
| ExclusionCriteria |
| Details |
1) Pre-existing breast conditions such as mastitis, abscesses, or a history of
previous such conditions
2) Participants with a history of breast surgery (e.g., implants, reduction, or
lumpectomy)
3) Women with severe postnatal complications (e.g., postpartum
hemorrhage, preeclampsia)
4) Women on medications that affect lactation (e.g., lactation suppressants,
hormone therapy)
5) Participants with open wounds, skin infections, or any dermatological
conditions on the breasts
6) Non-cooperative patients
7) Medical conditions affecting circulation or requiring specific treatments
8) Women who are unable to give consent or participate due to language
barriers or cognitive issues.
9) Participants who decline to provide informed consent or are unwilling to
comply with the study requirements. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Six point breast engorgement scale |
Pre intervention baseline, Post intervention immediately, 24 hours, post intervention fourth day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numerical Pain Rating Scale |
Pre intervention baseline, Post intervention immediately, 24 hours, post intervention fourth day |
|
|
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)
|
11/11/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 aims to compare the effectiveness of the Gua Sha technique and the Therapeutic Breast massage technique for the treatment of breast engorgement in postnatal women. Procedure of the study is approval from the Institutional Ethical Committee, which is obtained before commencing the study. CTRI registration will be done. Participants will be selected based on inclusion and exclusion criteria.
All the participants will be informed about the study, and a written
consent form will be taken from them. 60 postnatal women will be randomly allocated to either intervention group, and outcomes including pain and severity of breast engorgement will be assessed. Data will be analyzed to determine comparative
effectiveness.
|