| CTRI Number |
CTRI/2020/04/024667 [Registered on: 16/04/2020] Trial Registered Prospectively |
| Last Modified On: |
05/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Trial to Study the Effectiveness of Manipulative Therapy. |
|
Scientific Title of Study
|
Manipulative therapy for Prolapsed lumbar Intervertebral disc (PLID) patients and relation with infectious diseases: A Randomized Controlled Trail. |
| 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 |
Associate Professor & Senior Consultant |
| Affiliation |
Centre for the Rehabilitation of the Paralysed |
| Address |
Centre for the Rehabilitation of the Paralysed
CRP Chapain Savar
Dhaka Bangladesh
1343
Other |
| Phone |
880753559949 |
| Fax |
7745069 |
| Email |
anwar_physiobd@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohammad Anwar Hossain |
| Designation |
Associate Professor & Senior Consultant |
| Affiliation |
Centre for the Rehabilitation of the Paralysed |
| Address |
Centre for the Rehabilitation of the Paralysed
CRP Chapain Savar
Dhaka Bangladesh
1343
Other |
| Phone |
880753559949 |
| Fax |
7745069 |
| Email |
anwar_physiobd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
K M Amran Hossain |
| Designation |
PhD associate |
| Affiliation |
Bangladesh Health Professions Institute |
| Address |
Department of Physiotherapy, Bangladesh Health Professions Institute, CRP- Chapain, Savar, Dhaka
1343
Other |
| Phone |
8801735661492 |
| Fax |
7745069 |
| Email |
amranphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mohammad Anwar Hossain |
| Address |
Department of Physiotherapy
Centre for the Rehabilitation of the Paralysed (CRP)
Chapain Savar Dhaka Bangladesh |
| 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 |
| Mohammad Anwar Hossain |
Centre for the rehabilitation of the Paralysed |
Musculoskeletal Unit
Department of Physiotherapy
Centre for the Rehabilitation of the Paralysed (CRP)
Chapain Savar Dhaka Bangladesh
|
880753559949
7745069
anwar_physiobd@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangladesh Health Professions Institute (BHPI), IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Selective Exercise and Physical modalities for 30 minutes, 3 times a day for 4 weeks |
| Intervention |
Manipulative Therapy |
McKenzie Directional Movement, Manual Therapy, Exercise for 30 minutes, 3 times a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Lumber disc prolapsed patients,
MRI will be determined by the diagnosis of PLID,
Those who are motivated and will give consent to include in the study |
|
| ExclusionCriteria |
| Details |
Patient suffering from serious pathological disease e.g. tumours, tuberculosis and others pathological problems,
Age level below 18 years and after 55 years- Without this group will not usually affected by PLID,
Undiagnosed patient- there is no confirm diagnosis of PLID,
Post-operative PLID patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain,Range of Motion,Disability level,Fear and avoidance |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life, anxiety and depression level |
6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/04/2020 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Applicable |
Publication Details
Modification(s)
|
Efficacy of McKenzie Manipulative Therapy on Pain, Functional Activity and Disability for Lumbar Disc Herniation: A Randomized Clinical Trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, investigator blind, parallel group, multi center trial to study the effectiveness of Manipulative therapy for 6 months in 200 patients who are having Prolapsed Lumber Intervertebral Disc (PLID). This study will be conducted in 7 centers (Divisional city) in Bangladesh. The primary outcome measures will be pain, range of motion, disability level, fear and avoidance level at 6 months.
|