| CTRI Number |
CTRI/2020/06/025528 [Registered on: 02/06/2020] Trial Registered Prospectively |
| Last Modified On: |
06/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A Case-control study to identify the risk factors of Prolapsed Lumbar Intervertebral Disc (PLID) Patients in Bangladesh |
|
Scientific Title of Study
|
Determinant of risk factors of Prolapsed Lumbar Intervertebral Disc (PLID) patients in Bangladesh |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Anwar Hossain |
| Designation |
Senior Consultant & Head of Physiotherapy Department |
| Affiliation |
Centre for the Rehabilitation of the Paralysed (CRP) |
| Address |
CRP, Chapain, Savar, Dhaka-1343
Department of Physiotherapy
1343
Other |
| Phone |
1753559949 |
| Fax |
|
| Email |
anwar_physiobd@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K M Amran Hossain |
| Designation |
Lecturer, MPT program |
| Affiliation |
Centre for the Rehabilitation of the Paralysed (CRP) |
| Address |
BHPI,CRP, Chapain, Savar, Dhaka-1343
Department of Physiotherapy
CRP, Chapain, Savar, Dhaka-1343
Department of Physiotherapy
1343
Other |
| Phone |
01735661492 |
| Fax |
|
| Email |
amranphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rubayet Shafin |
| Designation |
Intern Physiotherapist |
| Affiliation |
Centre for the Rehabilitation of the Paralysed (CRP) |
| Address |
CRP, Chapain, Savar, Dhaka-1343
Department of Physiotherapy
CRP, Chapain, Savar, Dhaka-1343
Department of Physiotherapy
1343
Other |
| Phone |
01710512500 |
| Fax |
|
| Email |
shafin.rubayet00@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre of the Rehabilitation of the Paralysed (CRP) |
|
|
Primary Sponsor
|
| Name |
Mohammad Anwar Hossain |
| Address |
Department of Physiotherapy,CRP,Savar, Dhaka |
| Type of Sponsor |
Other [Self funded] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mohammad Anwar Hossain |
Centre of the Rehabilitation of the Paralysed (CRP) |
CRP, Chapain, Savar, Dhaka-1343
Department of Physiotherapy
|
1753559949
anwar_physiobd@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CRP Ethics Committee, Centre for the Rehabilitation of the Paralysed (CRP) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Lumbar disc prolapsed patients who have confirmed to diagnosis PLID by MRI. |
|
| ExclusionCriteria |
| Details |
Patients will be diagnosed of PLID with other serious associated diseases.
Those lumbar disc prolapsed patients who were also suffering from other serious diseases will change the exact outcome because associated disease creates a different effect on the lumbar disc prolapsed patients.
Any severe fracture or red flag sign of lumbar spine. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the risk factors affecting the prolapsed lumberintervertebral disc (PLID) patients in Bangladesh |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To explore the relationship between lumbar disc prolapsed of the patients with socio-demographical & socio- economical factors and possible risk factors for PLID patients in Bangladesh.
To determine disability level of PLID patients and identifying the relationship between Physical activities and PLID among the PLID suffered people. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="700"
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) |
07/06/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Title: Determinants of risk factors of Prolapsed Lumber Intervertibral disc (PLID) patients in Bangladesh.
General objective: To determine the risk factors affecting the prolapsed lumbar intervertibral disc (PLID) patients. Specific objectives: · To explore the relationship between lumbar disc prolapsed of the patients with socio-demographical & socio- economical factors. · To find out possible risk factors of PLID patients and its association with it. · To determine disability level of PLID patients · To identify the relationship between affecting lumbar disc prolapsed and pattern of physical activities. · To assess the behavior and life style of the lumbar disc prolapsed patients. T To identify the relationship between ergonomically factors and lumbar disc prolapsed. To To explore the relationship between Sports factors and lumbar disc prolapsed.
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