| CTRI Number |
CTRI/2014/12/005273 [Registered on: 10/12/2014] Trial Registered Retrospectively |
| Last Modified On: |
07/12/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to observe changes of nerve conduction and symptom findings in people with carpal tunnel syndrome before and after treatment with methylprednisolone |
|
Scientific Title of Study
|
A study to evaluate the correlation between neuroelectrophysiological and clinical parameters in
adults with carpal tunnel syndrome in Eastern India before and after treatment with
methylprednisolone |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pinaki Das |
| Designation |
Demonstrator Department of Physiology |
| Affiliation |
Demonstrator, Department of Physiology |
| Address |
Calcutta National Medical College
32 Gorachand Road
Kolkata
Calcutta National Medical College
32 Gorachand Road
Kolkata
Kolkata
WEST BENGAL
700014
India |
| Phone |
8436934049 |
| Fax |
|
| Email |
rangojvvcomc@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pinaki Das |
| Designation |
Demonstrator Department of Physiology |
| Affiliation |
Demonstrator, Department of Physiology |
| Address |
Calcutta National Medical College,
32 Gorachand Road
Calcutta
Calcutta National Medical College,
32 Gorachand Road
Calcutta
Kolkata
WEST BENGAL
700014
India |
| Phone |
8436934049 |
| Fax |
|
| Email |
rangojvvcomc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parasar Ghosh |
| Designation |
Associate Professor |
| Affiliation |
Department of Rheumatology and Clinical Immunology IPGMER |
| Address |
Department of Rheumatology and Clinical Immunology IPGMER Kolkata
Department of Rheumatology and Clinical Immunology IPGMER Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433988317 |
| Fax |
|
| Email |
drparasar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiology,
IPGME&R,Kolkata-700020 |
|
|
Primary Sponsor
|
| Name |
Department of Physiology IPGMER |
| Address |
Kolkata-700020 |
| Type of Sponsor |
Government medical college |
|
|
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 Pinaki Das |
Department of Physiology IPGMER |
IPGMER Kolkata-700020
Kolkata
WEST BENGAL |
84363934049
rangojvvcomc@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IPGMER Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Carpal Tunnel Syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj.Methylprednisolone |
40mg intracarpal single dose in affected hand,no comparator used |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients with symptoms of pain, tingling,numbness in hands |
|
| ExclusionCriteria |
| Details |
Diabetes,hypothyroidism,uraemia,pregnancy,previous treatment of CTS,fracture of wrist or hand |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Electrophysiological changes of median motor and sensory conduction velocity before and after treatment |
Before and at 1,2 and 3 months after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of symptom status before and after treatment |
Before and at 1,2 and 3 months after treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was designed to assess the electrophysiological and clinical changes in patients with Carpal Tunnel Syndrome before and after treatment with single dose local injection of methylprednisolone into each affected carpal tunnel.It was conducted at IPGME&R, Kolkata.We recruited 30 patients of whom finally 18 completed the study. Assessment was done at intervals designated above. It was found that a statistically significant reduction (p<0.01) in median motor and sensory conduction velocity were obtained 1 month after treatment. |