| CTRI Number |
CTRI/2024/10/075908 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| 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
|
effect of deep transverse friction massage and vibrating foam roller on neck pain in breast feeding mothers |
|
Scientific Title of Study
|
IMMEDIATE EFFECTS OF DEEP TRANSVERSE FRICTION MASSAGE VERSUS VIBRATING FOAM ROLLER IN NURSING MOTHERS WITH NECK PAIN: A COMPARATIVE 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 |
Aishwarya Varadai |
| Designation |
PG Student |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Room number 39 , Advanced Physiotherapy Centre, Sagar floor, KLE PBK Hospital Nehru Nagar , Belagavi , Karanataka , INDIA
Belgaum
KARNATAKA
590010
India |
| Phone |
8277747247 |
| Fax |
|
| Email |
aishwaryavaradai25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Deepti Bagewadi |
| Designation |
Associate Professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Room number 39 , Advanced Physiotherapy Centre, Sagar floor, KLE PBK Hospital Nehru Nagar , Belagavi , Karanataka , INDIA
Belgaum
KARNATAKA
590010
India |
| Phone |
9964608727 |
| Fax |
|
| Email |
deeptibagewadi@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.VIJAYALAXMI KANABUR |
| Designation |
Assistant Professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Room number 39 , Advanced Physiotherapy Centre, Sagar floor, KLE PBK Hospital Nehru Nagar , Belagavi , Karanataka , INDIA
Belgaum
KARNATAKA
590010
India |
| Phone |
8867480565 |
| Fax |
|
| Email |
vvkdeeksha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 39 , Advanced Physiotherapy Centre, Sagar floor, KLE PBK Hospital Nehru Nagar , Belagavi , Karanataka , INDIA |
|
|
Primary Sponsor
|
| Name |
AISHWARYA VARADAI |
| Address |
Room number 39 , Advanced Physiotherapy Centre, Sagar floor, KLE PBK Hospital Nehru Nagar , Belagavi , Karanataka , INDIA 590010 |
| 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 |
| DRVIJAYALAXMI KANABUR |
Breastfeeding Mothers of Belagavi City |
BELAGAVI NORTH AND SOUTH BELAGAVI KARNATAKA
Belgaum
KARNATAKA |
8867480565
vvkdeeksha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional research and ethical committe, KAHER INSTITUTE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O758||Other specified complications of labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Deep transverse friction massage |
The technique will be carried out in the relaxed position of muscles Deep transverse friction massage will be applied using fore finger which will be reinforced by middle finger.
Friction will be applied slowly with pressure slightly painful.
Massage will be deep and will be applied transversely to the tissue for 3mins.
|
| Comparator Agent |
Vibrating foam roller |
MYOFASCIAL RELEASE USING FOAM ROLLER
Participant will be in supine position and will be asked to apply self massage to C7
And T1 segments of the neck using a vibrating foam roller for 90s with 30s of rest FOR 3 TIMES at a frequency of 30 Hz
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
primigravida Nursing Mothers between age group of 20 to 40 years of age.
1.Exclusive breast feeding for atleast 3months.
2.Subjects with neck pain with pain range of moderate to severe on numeric pain rating
scale.
•
Subjects willing to participate. |
|
| ExclusionCriteria |
| Details |
ubjects with diagnosed orthopedic and neurological disorders.
• Any history of spinal trauma and spinal surgery in the past one year.
• Subjects with twins/triplets/quadruplets. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain using Numeric pain rating scale
Range of motion using universal goniometer |
baseline and endline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/11/2024 |
| Date of Study Completion (India) |
21/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Immediate effects of deep transverse friction massage versus vibrating foam roller in nursing mothers with neck pain : A comparative Study Aim- To compare immediate effects of deep transverse friction massage versus vibrating foam roller on pain and range of motion in nursing mothers with neck pain.
Null Hypothesis- There will be no difference in the effect of Deep Transverse Friction Massage and Vibrating Foam Roller in nursing mothers with neck pain in terms of Pain and range of motion. Alternate Hypothesis-There will be difference in the effect of Deep Transverse Friction Massage and Vibrating Foam Roller in nursing mothers with neck pain in terms of Pain and Range of motion. INCLUSION AND EXCLUSION CRITERIA: Inclusion Criteria Primiparous Nursing Mothers between age group of 20 to 40 years of age. Exclusive breast feeding for atleast 3months. Subjects with neck pain with pain range of moderate to severe on numeric pain rating scale.
Subjects willing to participate Exclusion criteria Subjects with diagnosed orthopedic and neurological disorders. Any history of spinal trauma and spinal surgery in the past one year. Subjects with twins/triplets/quadruplets.
Procedure Ethical Clearance will be obtained by Institutional Ethical Committee. CTRI Registration will be done after Ethical Clearance . According to Helsinki principles and ICMR Guidelines the following research will be conducted . Nursing mothers will be approached and screened for exclusion and inclusion criteria. Those fulfilling inclusion criteria will be explained the purpose of study in their own vernacular language and written informed consent will be obtained. Demographic data , Duration and Frequency of breast feeding will be collected . Baseline assessment of Pain , Range of motion will be done. Nursing mothers will be randomly allocated into two different two groups (GROUP A & GROUP B) Group A will receive Deep Transverse Friction Massage and Group B will receive Vibrating Foam Roller. Post intervention assessment of pain and range of motion will be done.
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