| 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
|
|
|
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
|
|
|
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. |