| CTRI Number |
CTRI/2024/12/078573 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effectiveness with ultrasound and without ultrasound corticosteroid injection in carpal tunnel syndrome |
|
Scientific Title of Study
|
Comparison of efficacy in ultra sound guided versus blind corticosteroid injection for carpal tunnel syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayan Baur |
| Designation |
Post Graduate Trainee |
| Affiliation |
R. G. Kar Medical College And Hospital |
| Address |
Room No. 110, OPD Building, Dept. of Physical Medicine and
Rehabilitation, R. G. Kar Medical College and Hospital 1, Khudiram
Bose Sarani, Kolkata
Kolkata
WEST BENGAL
700004
India |
| Phone |
9830961763 |
| Fax |
|
| Email |
bumbaa0002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar Mandal |
| Designation |
Professor and Head, Department of PMR, RGKMCH |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Dept. of PMR, R. G. Kar Medical College, 1, Khudiram Bose Sarani,
Kolkata
WEST BENGAL
700004
India |
| Phone |
9433915696 |
| Fax |
|
| Email |
rehabyouall@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Kumar Mandal |
| Designation |
Professor and Head, Department of PMR, RGKMCH |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Dept. of PMR, R. G. Kar Medical College, 1, Khudiram Bose Sarani,
Kolkata
WEST BENGAL
700004
India |
| Phone |
9433915696 |
| Fax |
|
| Email |
rehabyouall@gmail.com |
|
|
Source of Monetary or Material Support
|
| R. G. Kar Medical College, Kolkata |
|
|
Primary Sponsor
|
| Name |
R. G. Kar Medical College, Kolkata |
| Address |
1, Khudiram Bose Sarani, Kolkata- 700004 |
| 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 Ayan Baur |
R. G. Kar Medical College and Hospital |
Department of Physical
Medicine and
Rehabilitation, Room
No. 110, Ground Floor,
OPD Building
Kolkata
WEST BENGAL |
9830961763
bumbaa0002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, R. G. Kar Medical College |
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 |
| Comparator Agent |
Corticosteroid injection in carpal tunnel (by blind method) |
Corticosteroid injection will be given in carpal tunnel syndrome patients in blind method or ultrasound guided method |
| Intervention |
Corticosteroid injection in carpal tunnel (ultrasound guided) |
Corticosteroid injection will be given in carpal tunnel syndrome patients in blind method or ultrasound guided method |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group: 18 – 70 years
2.Both the genders. (males, females and others)
3.Diagnosed cases of CTS (Carpal Tunnel Syndrome). |
|
| ExclusionCriteria |
| Details |
Cases with previous carpal tunnel syndrome
Cases with history of previous corticosteroid therapy
Pregnancy
Cases with psychiatric history
Cases with peripheral polyneuropathy like in diabetes
Cases with history of traumatic nerve injury
Focal nerve entrapment other than CTS
Rheumatoid arthritis
Hypothyroidism
Cases refusing to carry forward with the study
Cases with any substance abuse addiction history
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess if any possible outcome difference in the process of corticosteroid injection
by US guided method in one group and blind method in the other group by using the BCTQ
(Boston Carpal Tunnel Questionnaire) |
Day0, Day28, Day84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess if any possible outcome difference in the process of corticosteroid injection
by US guided method in one group and blind method in the other group by using the SNAP
(Sensory Nerve Action Potential), SNCV (Sensory Nerve Conduction Velocity) |
Day0, Day28, Day84 |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The most common entrapment neuropathy in the upper limbs is carpal tunnel
syndrome (CTS). CTS is brought on by compression of the median nerve in the wrist while
passing through the carpal tunnel. Compression of the nerve causes ischemia which leads to
nerve damage and impairs its ability to function properly. Multiple options exist for treatment, which may be widely divided into two
categories: surgical intervention and non-surgical intervention. Both blind and ultrasound guided injections of steroids into the wrist frequently work. This study is to evaluate and compare the effectiveness between US guided injection
of corticosteroid and blind injection of corticosteroid in the management of CARPAL TUNNEL
SYNDROME(CTS). It will be a prospective randomized control study and will be conducted in the department of Physical Medicine and
Rehabilitation in R.G.KAR. Medical College and Hospital, Kolkata, West-Bengal. Sample size calculated was 52 i.e. 26 participants in each group. Symptomatic severity and functional severity will be measured using Boston Carpal Tunnel Questionnaire (BCTQ) symptom severity scale and function severity scale respectively at 4 weeks and 12 weeks post intervention and neurological outcome will be measured using SNAP
(Sensory Nerve Action Potential), SNCV (Sensory Nerve Conduction Velocity). |