| CTRI Number |
CTRI/2025/07/090936 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Validity of Ultrasonography in Low Back Pain |
|
Scientific Title of Study
|
Concurrent Validity and Test-Retest Reliability of Ultrasonography-guided
Musculoskeletal Evaluation of Non-specific 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 |
Sheoshree Roy Dola |
| Designation |
Undergraduate student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room - 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh
7408
Other |
| Phone |
8801705498307 |
| Fax |
|
| Email |
dola82653@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kazi Md Amran Hossain |
| Designation |
Lecturer |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room - 302, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh
7408
Other |
| Phone |
8801735661492 |
| Fax |
|
| Email |
kma.hossain@just.edu.bd |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kazi Md Amran Hossain |
| Designation |
Lecturer |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room - 302, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh
7408
Other |
| Phone |
8801735661492 |
| Fax |
|
| Email |
kma.hossain@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Level 2 and 3, Dr. M R Khan Medical Center, Jashore University of Science and Technology, Jashore-7408, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Dr Ehsanur Rahman |
| Address |
Room - 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh |
| Type of Sponsor |
Other [University] |
|
|
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 Kabir Hossain |
Dr. M R Khan Medical Center |
Room - 301, Department of Physiotherapy and Rehabilitation, Musculoskeletal Lab, Jashore University of Science and Technology, Jashore-7408, Bangladesh
|
8801778315139
kabir2002pt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of Department of Physiotherapy & Rehabilitation, JUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NIL |
| Comparator Agent |
NA |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
For patients with Low Back Pain (LBP):
1. Age between 20 to 40 years, both male and female.
2. Pain intensity on VAS score between 3 to 7 (moderate pain).
3. X-ray of the lumbar spine showing altered lumbar curvature suggestive of paraspinal muscle spasm.
For healthy volunteers (without LBP):
1. Age between 20 to 40 years, both male and female.
2. No pain or palpable muscle spasm.
3. X-ray of the lumbar spine showing normal findings.
|
|
| ExclusionCriteria |
| Details |
For patients with low back pain:
1.patients with positive Dural sign and SLUMP test positive
2.patients having SLR positive
For healthy volunteers:
1.History of low back pain last six months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| concurrent validity and test retest reliability |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pre & post treatment Reliability of ultrasonography |
30 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) |
23/07/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kma.hossain@just.edu.bd].
- For how long will this data be available start date provided 01-12-2025 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Nonspecific low back pain is the commonest form of LBP, where the biomechanical abnormalities of the lumbar spine pose abnormal pressure to the muscles, ligaments, and fascial tissues of the lower back. Existing radiological investigations are used only to rule out other causes, so healthcare practitioners manually palpate the paraspinal muscles to diagnose NSLBP. So far, the diagnosis and clinical evaluation of NSLBP is done by patient-reported subjective tools of pain and function. Ultrasonography-guided real-time morphological and clinical evaluation of the muscles, ligaments, fascia, and other soft tissues of the lumbar region might be the future of the diagnosis of specific structural abnormalities in NSLBP. The study objectives are justified to improve the global standard of diagnosis and management for NSLBP regardless of clinical specialty. The musculoskeletal ultrasonography laboratory is fully equipped and functional to conduct the study, and we also have access to a large number of LBP patients at musculoskeletal outpatient unit in this department. |