| CTRI Number |
CTRI/2025/02/081125 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Profile of Carpal Tunnel Syndrome (CTS) patients in a tertiary hospital |
|
Scientific Title of Study
|
Electrodiagnostic and Biophysical Profile of Carpal Tunnel Syndrome (CTS) patients in a tertiary hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chitturi Vinay |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Physiology, First Floor Academic Block
AIIMS Rajkot, Khanderi-Parapipaliya
Rajkot
GUJARAT
360110
India |
| Phone |
9968969775 |
| Fax |
|
| Email |
vinaychitturi1729@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chitturi Vinay |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Physiology, First Floor Academic Block
AIIMS Rajkot, Khanderi-Parapipaliya
GUJARAT
360110
India |
| Phone |
9968969775 |
| Fax |
|
| Email |
vinaychitturi1729@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chitturi Vinay |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Physiology, First Floor Academic Block
AIIMS Rajkot, Khanderi-Parapipaliya
GUJARAT
360110
India |
| Phone |
9968969775 |
| Fax |
|
| Email |
vinaychitturi1729@gmail.com |
|
|
Source of Monetary or Material Support
|
| Unfunded Project, Department already in possession of necessary equipment
Department of Physiology, AIIMS Rajkot
Khanderi Parapipaliya
Rajkot
360110 |
|
|
Primary Sponsor
|
| Name |
AIIMS Rajkot |
| Address |
Aiims Rajkot, Khanderi Pipaliya, Rajkot Gujarat 360110 |
| 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 Chitturi Vinay |
AIIMS Rajkot |
Department of Physiology, First Floor Academic Block
AIIMS Rajkot, Khanderi-Parapipaliya
Rajkot
GUJARAT |
9968969775
vinaychitturi1729@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G560||Carpal tunnel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients diagnosed with CTS by Nerve Conduction studies
|
|
| ExclusionCriteria |
| Details |
Patients with comorbidities like Polyneuropathy/ Multineuropathy.
Patients diagnosed with other differential Diagnosis like Proximal Median Neuropathy and C6,C7 Radiculopathy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
CTS Electrophysiological Grade
Boston Carpal Tunnel Questionaire score |
0 months
4-6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Risk Factors for CTS severity |
0 months
4-6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
04/03/2025 |
| 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) |
Open to Recruitment |
|
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
|
Carpal Tunnel Syndrome (CTS) is a common entrapment neuropathy due to compression of the median nerve below the flexor retinaculum at the carpal tunnel of the wrist. A clinical diagnosis of CTS can be established based on clinical findings like Numbness, Tingling and Paresthesia in the lateral 3.5 digits of palm (sensory field of the median nerve) motor weakness and wasting of the muscles of the thenar eminence,Tinel sign and Phalen’s sign. The severity of symptoms and functional status of patients with CTS can be assessed by clinical questionnaires like Boston Carpal Tunnel Questionnaire (BCTQ) (1). Electrodiagnostic tests like nerve conduction studies objectively demonstrate a focal slowing or conduction block of the median nerve at the wrist and can quantify the electrodiagnostic severity of CTS (2).These tests are interpreted with clinical correlation to achieve the final diagnosis. CTS can be treated by conservative orthotics, steroid injections or a surgical release procedure (3). |