| CTRI Number |
CTRI/2024/10/075799 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How commen is the occurrence of sciatica in general population |
|
Scientific Title of Study
|
A study on prevalanve of sciatica |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asiya Fatima |
| Designation |
Pg scholar of PSM Department GNTC |
| Affiliation |
KNR UNIVERSITY |
| Address |
OPD room number 102, Department of Preventive and Social Medicine, Govt Nizamia Tibbi Collage and General hospital Charminar,Hyd. affiliated by KNR university
Hyderabad
TELANGANA
500002
India |
| Phone |
|
| Fax |
|
| Email |
asiyyafatima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maqbool Hussain |
| Designation |
Professor and HOD of psm department GNTC |
| Affiliation |
|
| Address |
OP NO 102, Department of Preventive and Social Medicine Govt Nizamia Tibbi Collage and General Hospital Charminar,hyd.
Hyderabad
TELANGANA
500002
India |
| Phone |
9948679786 |
| Fax |
|
| Email |
maqboolahmar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asiya Fatima |
| Designation |
Pg Scholar PSM Department GNTC |
| Affiliation |
KNR UNIVERSITY |
| Address |
OP room no 102 Department of PSM Govt Nizamia Tibbi Collage and Hospital Charminar hyd.
Hyderabad
TELANGANA
500002
India |
| Phone |
09618902887 |
| Fax |
|
| Email |
asiyyafatima@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of preventive and social medicine Govt Nizamia Tibbi Collage and General Hospital Charminar Hyd |
|
|
Primary Sponsor
|
| Name |
Dr Asiya Fatima |
| Address |
OPD no 102, Department of PSM Govt Nizamia Tibbi Collage and General Hospital Charminar Hyd |
| 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 |
| Dr Asiya Fatima |
Govt Nizamia Tibbi Collage and General Hospital |
OPD no 102, Department of Preventive and Social Medicine
Hyderabad
TELANGANA |
9618902887
asiyyafatima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G570||Lesion of sciatic nerve, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
patients complains with typical radiating pain in distribution of sciatic nerve in one leg combined with positive result of one or more neurological test indicating nerve root tension |
|
| ExclusionCriteria |
| Details |
Patients who are not giving informed consent
patients with rheumatological diseases
or other complications
leg pain originating from upper lumbar column |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence and risk factors of sciatica in sample size of 200 patients |
1week |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
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
|
- Sciatica is a condition in which pain emanating from lower back is felt along the distribution of the sciatica nerve in lower extremities. Sciatica pain spreads over the buttocks, posterolateral part of thigh , posterolateral part of the leg , passes over the instep and ends at three big toe.Prevalence of sciatica is 1.6 in general population to 43 percent in selected working population. Study conducted in orthopedic dept Renee hospital karimnagar 2020, Prevalence was 46 percent.
|