| CTRI Number |
CTRI/2025/07/091832 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Abdominal Exercises for Back Pain in Mothers after Cesarean |
|
Scientific Title of Study
|
Effectiveness of Community-based Rehabilitation endorsed with Abdominal Capsule Muscles Stabilization Exercise for the Management of Postpartum Low back pain in Cesarean-section Mother |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khandoker Faria Zaman |
| Designation |
Undergraduate Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room No.301, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408 Other |
| Phone |
8801306543615 |
| Fax |
|
| Email |
fariazaman76@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Md Feroz Kabir |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room No.409, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408 Other |
| Phone |
8801765932545 |
| Fax |
|
| Email |
feroz@just.edu.bd |
|
Details of Contact Person Public Query
|
| Name |
Dr Md Feroz Kabir |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room No.409, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408 Other |
| Phone |
8801765932545 |
| Fax |
|
| Email |
feroz@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Dr MR Khan Medical Center, Level 3, Room 301, Musculoskeletal lab, 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 [University] |
|
|
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 Md Kabir Hossain |
Dr MR Khan Medical Centre |
Level 3,Room No.301, Musculoskeletal lab, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408
|
8801778 315139
kabir2002pt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of Physiotherapy and Rehabilitation, JUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Abdominal capsule muscles stabilization exercise |
Diaphragmatic breathing:3 days per week,5–10 min; Pelvic floor contractions:3 days per week, 5–10 min; Transverse abdominis engagement:3 days per week, 5–10 min; Multifidus activation (bird-dog exercise): 3 days per week, 10 min for 8 weeks
|
| Comparator Agent |
Postural education |
Sitting & breastfeeding posture, Proper lifting techniques, Standing with neutral spine, Ergonomic sleep advice, Avoiding harmful bending;45 minutes per session in a month for 2 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Females aged 18 to 40 years, postpartum mothers who have undergone cesarean section, At least 6 weeks after cesarean section, Presenting with low back pain, Willing to participate and provide informed consent
|
|
| ExclusionCriteria |
| Details |
History of low back pain (LBP) before pregnancy, Complicated deliveries; e.g., requiring intensive interventions, prolonged hospitalization; Recent traumatic history; e.g., falls, accidents, Uncontrolled medical conditions, such as diabetes, hypertension, or heart disease, Presence of red flags, including radiating pain, numbness, or signs of serious pathology
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain by Visual Analogue Scale (VAS) |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess functional disability related to low back pain by Oswestry Disability Index (ODI); To measure muscle strength by Biofeedback
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40" 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) |
11/08/2025 |
| 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-identification.
- 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 [feroz@just.edu.bd].
- For how long will this data be available start date provided 01-02-2026 and end date provided 01-02-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study will assess the effectiveness of a community-based rehabilitation program combined with abdominal muscle stabilization exercises in managing low back pain among postpartum mothers after cesarean section. Eligible mothers aged 18–40 years, at least 6 weeks post-cesarean, will be randomly assigned to receive either postural education alone or postural education plus therapeutic exercises over 8 weeks. Outcomes will be measured using VAS, ODI, and Biofeedback. |