| CTRI Number |
CTRI/2024/10/075986 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Motor Control Exercise for low back pain |
|
Scientific Title of Study
|
Efficacy of Motor Control Exercise in patients with chronic low back pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nurul Sadek Sajib |
| Designation |
Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no:304, Department of Physiotherapy and Rehabilitation, Dr.
M R Khan Medical Center, Jashore University of Science and
Technology, Jashore, Bangladesh.
7408
Other |
| Phone |
01706655520 |
| Fax |
|
| Email |
sadeksajib99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Zahid Hossain |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no:410, Department of Physiotherapy and Rehabilitation, Dr.
M R Khan Medical Center, Jashore University of Science and
Technology, Jashore, Bangladesh.
7408
Other |
| Phone |
01670962775 |
| Fax |
|
| Email |
mz.hossain@just.edu.bd |
|
Details of Contact Person
Public Query
|
| Name |
Dr. K M Amran Hossain |
| Designation |
Lecturer |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no:308, Department of Physiotherapy and Rehabilitation, Dr.
M R Khan Medical Center, Jashore University of Science and
Technology, Jashore, Bangladesh.
7408
Other |
| Phone |
01735661492 |
| Fax |
|
| Email |
amranphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. M R Khan Medical Center
Jashore University of Science and Technology, Jashore-7408, Bangladesh. |
|
|
Primary Sponsor
|
| Name |
Nurul Sadek Sajib |
| Address |
Room no:304, Department of Physiotherapy and Rehabilitation, Dr.
M R khan Medical Center, Jashore University of Science and
Technology, Jashore, Bangladesh.
|
| Type of Sponsor |
Other [ Self-Funded] |
|
|
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 Tofajjal Islam Tuhin |
Musculoskeletal Physiotherapy Lab. Jashore university of Science and Technology |
Room no:301,
Department of
Physiotherapy and
Rehabilitation, Dr. M R
khan Medical Center,
Jashore University of
Science and
Technology, Jashore,
Bangladesh.
|
01778790798
yousufraju6423@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board Jashore University of Science and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Care Myofasical Release (MFR) |
Apply myofasical release on para-spinal muscle 5-7 minute and stretching on qudratus lumborum, gluteus, piriformis in lying 5-7 repetations, 15-30 secounds hold along with electrotherapy choose by the Therapist accourding to patient preference. 30-40minute sessions, with three sessions per week for up to 4 weeks. |
| Intervention |
Motor Control Exercise |
Motor control exercise focus on specific muscle Transverse abdominis and mulitifidus also work other abdominal muscles following the technique Abdominal drawing-in maneuver (ADIM). 30-40minute sessions, with three sessions per week for up to 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Male and female between 18 and 65 years old; 2) Having LBP for more than 3 months; 3) Pain intensity from 3 to 7 in NPRS; 4) The written informed consent of the participants. |
|
| ExclusionCriteria |
| Details |
1) Prior Lumber spine surgery; 2) A history of congenital/acquired postural deformity, tumor, instability, inflammatory disease, spinal cord compression, fracture or infection. 3) Severe Osteoporosis, Arthritis or bone disease; 4) Unstable or severe disabling chronic cardiovascular and pulmonary disease. 5) History of serious psychological or psychiatric illness. 6) current pregnancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain and Endurance
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional Disability and Global perceived effect
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
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)
|
05/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/11/2024 |
| 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)
Modification(s)
|
Open to Recruitment |
| 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
Modification(s)
|
The aim of this study is to evaluate the efficacy of Motor Control Exercise in chronic Low Back Pain
The process I will continue, in short:
Pt enrollment Randomization Pre-test Post test follow-up
After the trial registration, the researcher will enroll the chronic low back pain patients through the initial screening. The patient will be allocated to two groups in the concealed process. Both groups will receive conventional physiotherapy specifically one group receive Convention Care and another MCE. The researcher will measure outcomes in baseline, pretest to post-test, and follow-up. In this study, the researcher will follow CONSORT guidelines.
|