| CTRI Number |
CTRI/2024/05/068075 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of Lumbar Intervertebral Disc Volume with Apparent
Diffusion Coefficient (ADC) values in the setting of lower back pain
in a tertiary care setup in central India |
|
Scientific Title of Study
|
Correlation of Lumbar Intervertebral Disc Volume with Apparent Diffusion Coefficient (ADC) Values in the Setting of Lower Back Pain in a Tertiary Care Setup in Central India. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bilqueesa Mushtaq |
| Designation |
PhD Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Acharya Vinoba Bhave rural hospital, a constituent unit of Jawaharlal Nehru medical College, Datta Institute of higher education and research (deemed to be a university), Wardha, Maharashtra, India
Department of radiodiagnosis, block D,
Acharya Vinoba Bhave Rural Hospital, Wardha, Maharashtra, 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9149849713 |
| Fax |
|
| Email |
bilqueesa.mushtaq@dmiher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav V. Mishra |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Acharya Vinoba Bhave rural hospital, a constituent unit of Jawaharlal Nehru medical College, Datta Institute of higher education and research (deemed to be university), Wardha, Maharashtra, India
Department of radiodiagnosis, block D, Acharya Vinoba Bhave Rural Hospital, Wardha, Maharashtra 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9171391739 |
| Fax |
|
| Email |
gaurav.mishra@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Bilqueesa Mushtaq |
| Designation |
PhD Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Acharya Vinoba Bhave rural hospital, a constituent unit of Jawaharlal Nehru medical College, Datta Institute of higher education and research (deemed to be university), Wardha, Maharashtra, India
Department of radiodiagnosis, block D, Acharya Vinoba Bhave Rural Hospital, Wardha, Maharashtra 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9149849713 |
| Fax |
|
| Email |
bilqueesa.mushtaq@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave rural hospital, a constituent unit of Jawaharlal Nehru medical College, Datta Institute of higher education and research (deemed to be university), Wardha, Maharashtra, India- 442001 |
|
|
Primary Sponsor
|
| Name |
Bilqueesa Mushtaq |
| Address |
Sawangi, Wardha, Maharashtra, India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bilqueesa Mushtaq |
Acharya Vinoba Bhave Rural Hospital/Jawaharlal Nehru Medical college |
department of radiodiagnosis, block-D, Sawangi (Meghe), Wardha - 442 004,
Maharashtra State, India
Wardha
MAHARASHTRA |
9149849713
bhatt.bilquees@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee DMIHER (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with non-specific lower back pain.
Above the age of 18 years who undergo for MRI L/S Spine during September 2022
September 2024.
|
|
| ExclusionCriteria |
| Details |
Post-surgery history of the lumbar spine.
History of a spinal tumor.
Any MRI artifacts.
Patients with any metal implants in the lumbar spine.
Patients who have claustrophobia.
known case of carcinoma with metastatic deposits in the spine. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
If any relation or equation exists in between the two variables i.e. intervertebral disc volume and the ADC values at the nucleus pulposus then that relation or equation will help in determining the early diagnosis of lower back pain with reference to the
ADC value and volume of the IVD, particularly the ratio in between the two variables. |
1-2yrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
10/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
To evaluate the relationship between the volume and apparent diffusion coefficient (ADC) value of the lumbar intervertebral discs in the setting of lower back pain. Disc degeneration is accompanied by changes in the volume of the disc and its microarchitecture. As the apparent diffusion coefficient (ADC) measures the diffusion of water molecules in a disc, so it can be used as a quantitative parameter to evaluate the pathological changes in a disc by measuring its water diffusion. |