| CTRI Number |
CTRI/2026/03/105178 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
01/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the skin findings in patients with spinal abnormalities on magnetic resonance imaging |
|
Scientific Title of Study
|
A cross-sectional study to assess the cutaneous manifestations in patients with spinal abnormalities on magnetic resonance imaging : exploring the skin - spine axis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aisha P A |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Mangalagiri |
| Address |
Department of Dermatology
All India Institute of Medical Sciences, Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8847803988 |
| Fax |
|
| Email |
aish.ahmd.3307@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Hima Gopinath |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Mangalagiri |
| Address |
Department of Dermatology
All India Institute of Medical Sciences, Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8847803988 |
| Fax |
|
| Email |
hima36@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aisha P A |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Mangalagiri |
| Address |
Department of Dermatology
All India Institute of Medical Sciences, Mangalagiri
ANDHRA PRADESH
522503
India |
| Phone |
8847803988 |
| Fax |
|
| Email |
aish.ahmd.3307@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Mangalagiri
AIIMS MG Campus, Mangalagiri, Guntur District Andhra Pradesh - 522503
India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Mangalagiri |
| Address |
AIIMS MG Campus
Mangalagiri
Guntur District
Andhra Pradesh
522503
India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Aisha P A |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, MANGALAGIRI |
Room 336
Department of Dermatology
Guntur
ANDHRA PRADESH |
8847803988
aish.ahmd.3307@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, ALL INDIA ISNTITUTE OF MEDICAL SCIENCES, MANGLAGIRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G30-G32||Other degenerative diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients consenting for the study
Patients who have been diagnosed with spinal pathology having potential to cause neuropathic cutaneous changes or neuropathic itch on Magnetic resonance imaging
Patients with skin conditions suggestive of neuropathic cutaneous changes and are undergoing MRI evaluation of spine.
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Contraindications for MRI
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Skin manifestations associated with spinal pathology |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Type & severity of spinal abnormalities, demographic data, association of severity between skin & spine abnormalities. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
12/03/2026 |
| 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="1"
Months="6"
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
|
During development of organs, skin and the spine share
a common embryological origin. There are multiple conditions of nerve impingement such as notalgia paresthetica , brachioradial pruritus in
which patients can present with localized pruritus. Neuropathic itch is the
sensation of pruritus resulting from neural dysfunction which can be localized
or generalised. Compression of spinal cord can also present with neuropathic
itch. This study aims to describe the skin changes seen in patients with
magnetic resonance imaging (MRI) showing spinal abnormalities. Patients who are meeting the inclusion criteria will
be explained about the procedure and informed contest will be taken. Data will
be collected according to case sheet and examination for skin changes and other
findings will be done. The changes in skin and
spinal abnormalities will be assessed in detail for their type, extent,
severity, grading. Few patients who
visit dermatology opd with potential neuropathic cutaneous changes will undergo
MRI evaluation. Data collected will be
stored in password protected system and confidentiality will be maintained. The
data will be statistically analysed |