| CTRI Number |
CTRI/2024/10/075451 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
An interventional study on 40 subjects to determine the effect of neuroplasty on different grades of carpal tunnel syndrome |
|
Scientific Title of Study
|
Effect of neuroplasty on different grades of median nerve dysfunction in carpal Tunnel syndrome |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Varshney |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesiology,Jawaharlal Nehru Medical College,AMU,Aligarh UttarPradesh 202001 India |
| Address |
Department of Anaesthesiology,Jawaharlal Nehru Medical College,AMU,Aligarh
UttarPradesh
202002
India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9368449361 |
| Fax |
|
| Email |
pvarshney96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hammad Usmani |
| Designation |
Professor |
| Affiliation |
AMU |
| Address |
Department of Anaesthesiology,Jawaharlal Nehru Medical College,AMU,Aligarh
UttarPradesh
202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897114190 |
| Fax |
|
| Email |
hammadusmani2002@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Varshney |
| Designation |
Junior Resident |
| Affiliation |
AMU |
| Address |
Department of Anaesthesiology,Jawaharlal Nehru Medical College,AMU,Aligarh
UttarPradesh
202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9368449361 |
| Fax |
|
| Email |
pvarshney96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology JNMCH,AMU,Aligarh,UP,202001 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical CareJawaharlal Nehru Medical College AMUAligarh |
| Address |
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College, AMU Aligarh,UTTAR PRADESH
202002 |
| 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 |
| DrPooja Varshney |
JNMC Hospital |
Department of Anaesthesiology,
Aligarh Muslim University
Uttar Pradesh
Aligarh
UTTAR PRADESH |
9368449361
pvarshney96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jawaharlal Nehru medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G629||Polyneuropathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect of neuroplasty on median nerve dysfunction in carpal tunnel syndrome |
All enrolled patients who are not responding to pharmacotherapy after 6 weeks of treatment will undergo median nerve neuroplasty under USG guidance, in Pain Clinic, Department of Anaesthesiology and Critical Care, at the wrist using linear high frequency USG probe. The USG probe will be placed on the anterior aspect of wrist. The nerve will be seen as a single elliptical hyperechoic structure with internal hypochoic circles. USG grading will be done on the basis of cross sectional area of median nerve. Skin above the target will be infiltrated with 0.5ml of 2%Lidocaineto avoid pain due to needle insertion. Insert the needle, 22G and Som in length, using in plane approach from radial side of probe. 3ml solution containing 0.25% Bupivacaine +Triamcinolone(20mg) will be infiltrated around the nerve as real time injection in patients with CTS. Care will be taken to visualize the spread of drug which distend the perineum around the median nerve and to avoid needle penetration of nerve tissue and intravascular injury. All patients will be monitored in recovery room after intervention for 4 hours. |
| Comparator Agent |
Not applicable |
Comparator agent not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Willingness of patient to participate in study.
2)Patient age between 20-60 yrs
3)Clinically and Electrophysiologically diagnosed as Carpal Tunnel Syndrome since last 6 weeks.
4)Either sex. |
|
| ExclusionCriteria |
| Details |
1)History of trauma.
2)Cervical radiculopathy.
3)Known patients of peripheral neuropathy of any other cause.
4)Pronator dysfunction
5)Patients having prior history of injectable corticosteroid
6) Patients with Motor dysfunction of the affected hand. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine effect of neuroplasty on different grades of median nerve dysfunction in carpal tunnel syndrome using Numerical Rating Scale. |
Patients will be assessed at 1;2;4 and 6 weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Neuroplasty on different grades of median nerve dysfunction using NCS.
2) To correlate the changes of median nerve cross sectional area on USG with Neurological Rating Scale and Nerve Conduction Studies before and after neuroplasty in different grades of median nerve dysfunction. |
Patients will be assessed at 1;2;4 and 6 weeks post intervention |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
Date of First Enrollment (India)
Modification(s)
|
15/11/2024 |
| 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="1"
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
|
All enrolled patients who are not responding to pharmacotherapy after 6 weeks of treatment will undergo median nerve neuroplasty under USG guidance, in Pain Clinic, Department of Anaesthesiology and Critical Care, at the wrist using linear high frequency USG probe. The USG probe will be placed on the anterior aspect of wrist. The nerve will be seen as a single elliptical hyperechoic structure with internal hypochoic circles. USG grading will be done on the basis of cross sectional area of median nerve. Skin above the target will be infiltrated with 0.5ml of 2%Lidocaineto avoid pain due to needle insertion. Insert the needle, 22G and Som in length, using in plane approach from radial side of probe. 3ml solution containing 0.25% Bupivacaine +Triamcinolone(20mg) will be infiltrated around the nerve as real time injection in patients with CTS. Care will be taken to visualize the spread of drug which distend the perineum around the median nerve and to avoid needle penetration of nerve tissue and intravascular injury. All patients will be monitored in recovery room after intervention for 4 hours. |