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CTRI Number  CTRI/2025/06/089650 [Registered on: 26/06/2025] Trial Registered Prospectively
Last Modified On: 26/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Jashore womens health project  
Scientific Title of Study   Effectiveness of an 8 week Physiotherapy intervention program for Rural Women having Lumber Disc Herniation with cauda Equina Syndrome in Jashore, Bangladesh. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K M Amran Hossain 
Designation  Lecturer 
Affiliation  Jashore University of Science & technology 
Address  Room no 304, level 2, Dr MR Khan Medical center, Department of Physiotherapy & Rehabilitation, Jashore University of Science & technology, Jashore, Bangladesh



7408
Other 
Phone  8801735661492  
Fax    
Email  kma.hossain@just.edu.bd  
 
Details of Contact Person
Scientific Query
 
Name  K M Amran Hossain 
Designation  Lecturer 
Affiliation  Jashore University of Science & technology 
Address  Room no 304, level 2, Dr MR Khan Medical center, Department of Physiotherapy & Rehabilitation, Jashore University of Science & technology, Jashore, Bangladesh



7408
Other 
Phone  8801735661492  
Fax    
Email  kma.hossain@just.edu.bd  
 
Details of Contact Person
Public Query
 
Name  K M Amran Hossain 
Designation  Lecturer 
Affiliation  Jashore University of Science & technology 
Address  Room no 304, level 2, Dr MR Khan Medical center, Department of Physiotherapy & Rehabilitation, Jashore University of Science & technology, Jashore, Bangladesh



7408
Other 
Phone  8801735661492  
Fax    
Email  kma.hossain@just.edu.bd  
 
Source of Monetary or Material Support  
Department of Physiotherapy & Rehabilitation, Jashore University of Science & Technology, Jashore 7408, Bangladesh 
 
Primary Sponsor  
Name  University of Brighton 
Address  School of Sport and Health Sciences, University of Brighton, UK Robert Dodd Building (Office: 124) 49 Darley Road, Eastbourne  
Type of Sponsor  Other [Official Development Assistance (ODA) grant from University of Brighton] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jahid Hasan  Nurul Islam Orthopedic Rehabilitation & Physiotherapy Care  Room no 01, Female OPD, NORC, Nil Roton Dhar road, Jashore-7400, Bangladesh

 
8801744129353

jahidhasantony@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB of Department of Physiotherapy & Rehabilitation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M512||Other thoracic, thoracolumbar andlumbosacral intervertebral disc displacement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mechanical diagnosis & therapy in directional preference and pelvic floor stabilization exercise   10 repetition per set, 3 sets a day, 10 % increase per week, total 8 weeks 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1) Low back pain with lower limb radicular symptoms
2) Lasegue sign and cross lasegue sign positive
3) Post Void Residuals purine volume more than 50 ml
4) Magnetic Resonance Imaging evidence of Lumbar disc herniation in single or multiple levels 
 
ExclusionCriteria 
Details  1) Degenerative Disc Disease of Lumbar spine
2) Any history of disc or spine surgery
3) Uncontrolled endocrine or metabolic disease.
4) Unwilling  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
pain at rest, sitting and standing in VAS scale, Neurological evaluation by ASIA impairment scale, and PVR by ultrasonography   56 days 
 
Secondary Outcome  
Outcome  TimePoints 
disability by Oswestry disability index  56 days 
 
Target Sample Size   Total Sample Size="60"
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)  10/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
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 - NO
Brief Summary  
Background – Cauda equina syndrome (CES) is a complication associated with lumbar disc herniation (LDH). Women in rural lower-middle income countries (LMIC) pose a greater risk of impairments to bladder and bowel control, sensory and motor functions, and may experience increased pain intensity due to a lack of accessibility to rehabilitation services. Physiotherapy management, the McKenzie technique and Kegels have previously demonstrated a positive impact on pain intensity, bowel and bladder control, and functioning in patients with LDH and CES. This study aims to explore the effectiveness of an eight-week Physiotherapy intervention in women with LDH and CES living in rural Bangladesh and their experiences of receiving rehabilitation.  
Methods – The study will be a mixed method using one arm pre and post-test design and in-depth interview with a convenience sampling will be carried out to evaluate the effectiveness of a Physiotherapy intervention program in women from rural villages surrounding Jashore, Bangladesh over an eight-week period. Data will be collected from the participants through pre-post-test outcome measures: Pain intensity using the Visual analogue Scale, neurological function through the American Spinal Injury Association (ASIA) assessment, bladder function using an ultrasonographic evaluation of post-void residual volume, pelvic floor function including strength and endurance using a dynamometer. Functioning will be measured through the Oswestry low back disability Index as a secondary outcome. Data will be analyzed using a paired t-test and regression analysis. Focus group interviews will also be conducted with a sub-sample of participants to explore their experiences of the intervention and receiving rehabilitation. This data will be analyzed using an inductive thematic reflexive approach. A concurrent triangulation approach will be adopted with quantitative and qualitative data being integrated at the point of interpretation and presented in a joint-display table. 
Discussion – This study aims to provide short-term rehabilitation and promote long-term self-management techniques to marginalized women with the highest risk of disability to enhance their physical and functional ability, social life and engagement in activities of daily living. We will reach a community that may otherwise have not sought treatment due to a lack of time and resources.
 
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