| CTRI Number |
CTRI/2025/07/091665 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Relieving neck and thoracic Pain in breastfeeding mothers through community-based care. |
|
Scientific Title of Study
|
Effectiveness of postural education and therapeutic exercise on neck and thoracic pain among breastfeeding mothers in community setting.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mst Sanzida Ara Islam |
| Designation |
Undergraduate student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room-304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801978991345 |
| Fax |
|
| Email |
sanzidamithila2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharmila Jahan |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room-307, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801717362485 |
| Fax |
|
| Email |
Sh.jahan@just.edu.bd |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharmila Jahan |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room-307, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801717362485 |
| Fax |
|
| Email |
Sh.jahan@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore 7408, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Dr Ehsanur Rahman |
| Address |
Room no 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ehsanur Rahman |
Dr MR Khan Medical centre |
Level 3, Room 301, Musculoskeletal lab, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore 7408, Bangladesh
|
8801716062263
chairman.ptr@just.edu.bd |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of Department of Physiotherapy and Rehabilitation, JUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M549||Dorsalgia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Postural education |
Postural education (6 weeks, 3 sessions per week, 30-45 minutes)
1.Education on correct breastfeeding postures
2.Advice on body alignment and neutral spine
3.Ergonomic tips for feeding, lifting, and baby care
4.Use of supportive tools
|
| Intervention |
Postural education and therapeutic exercise |
Postural education+ Therapeutic exercise(6 weeks, 3 sessions per week, 30-45 minutes)
Postural education :
1.Education on correct breastfeeding postures
2.Advice on body alignment and neutral spine
3.Ergonomic tips for feeding, lifting, and baby care
4.Use of supportive tools
Therapeutic exercise:
1.Stretching of neck, shoulder, and thoracic muscles(3 times per week, 30 minute)
2.Strengthening exercises(3times per week, 30 minute)
breathing techniques
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Mothers age between 18-40 years
Have been breastfeeding for at least 6 weeks to 2 years
Have experienced neck and/or thoracic pain for at least 2 weeks
Are able to follow instructions and participate in exercise sessions
|
|
| ExclusionCriteria |
| Details |
Have a recent history of trauma, fracture or surgery in neck or thoracic region.
History of neurological disorders (stroke, cervical myelopathy).
Have severe musculoskeletal or rheumatic conditions (Ankylosing Spondylitis, scoliosis)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain by VAS Scale |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Range of motion by digital inclinometer
Disability by neck disability index and thoracic oswesrty disability index |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="0"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/07/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Sh.jahan@just.edu.bd].
- For how long will this data be available start date provided 24-02-2026 and end date provided 13-03-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
his randomized controlled trial investigates the effectiveness of a combined intervention consisting of postural education and therapeutic exercises in reducing neck and thoracic pain among breastfeeding mothers aged between 18 to 40 years. Participants are randomly allocated into intervention and control group. Pain is assessed using the Visual Analogue Scale. Range of motion is assessed by digital inclinometer and disability are assessed by neck disability index and thoracic oswestry disability index, delivered three times per weeks for 6 weeks. The intervention is delivered in a community setting and aims to promote better postural habits and muscular function to alleviate discomfort associated with breastfeeding posture. The study evaluates pain reduction over time, comparing outcomes between intervention and control groups. |