| CTRI Number |
CTRI/2024/01/061292 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
04/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomised controlled study to compare the effectiveness of 5% dextrose and triamcinolone in the carpal tunnel syndrome patients who are refractory to conservative therapy |
|
Scientific Title of Study
|
Comparsion of 5% dextrose versus triamcinolone in the carpal tunnel syndrome patients refractory to conservative therapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dewanshi Agrawal |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal nehru medical college,aligarh muslim university,aligarh |
| Address |
Department OF Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College,
Aligarh Muslim University ,ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9752026600 |
| Fax |
|
| Email |
adewanshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Hussain Amir |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal nehru medical college,aligarh muslim university,aligarh |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE
JAWAHARLAL NEHRU MEDICAL COLLAGE
ALIGARH MUSLIM UNIVERSITY, ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897559183 |
| Fax |
|
| Email |
hussainamir77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dewanshi Agrawal |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal nehru medical college,aligarh muslim university,aligarh |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE
JAWAHARLAL NEHRU MEDICAL COLLAGE
ALIGARH MUSLIM UNIVERSITY, ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9752026600 |
| Fax |
|
| Email |
adewanshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology and critical care,Jawaharlal nehru medical college,aligarh muslim university,aligarh |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology and critical care,Jawaharlal nehru medical college,AMU,aligarh |
| Address |
Department of anaesthesiology and critical care,Jawaharlal nehru medical college,AMU,aligarh |
| 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 Dewanshi agrawal |
Jawaharlal Nehru Medical College and Hospital |
Department of anaesthesiology and critical care,Jawaharlal nehru medical college, AMU, Aligarh
Aligarh
UTTAR PRADESH |
9752026600
adewanshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
median nerve block at wrist joint |
ultrasound guided one session of 2 minute duration of perineural median nerve block at the level of wrist joint using 5% dextrose in patients of carpal tunnel syndrome refractory to conservative therapy. 3 ml of 5% dextrose is used. |
| Comparator Agent |
median nerve block at wrist joint |
ultrasound guided one session of 2 minute duration of perineural injection in median nerve at the level of wrist joint using triamcinolone in patients of carpal tunnel syndrome refractory to conservative therapy. 1 ml of triamcinolone mixed with 2 ml of normal saline is used. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with mild to moderate Carpal tunnel syndrome with symptoms of Nocturnal paresthesia/dysthesia with or without pain over the subjected, which could be associated with posture or overuse of the wrist, or relieved with shaking motion of the hand may or may not be associated with numbness in the sensory distribution of Median nerve
|
|
| ExclusionCriteria |
| Details |
patients with history of polyneuropathy, brachial plexopathy, thoracic outlet syndrome or wrist surgery.
patients with History of inflammatory arthritis, hypothyroidism, pregnancy, and rheumatological disorder or having pacemaker.
patients who are on warfarin use, previous steroid injection for CTS, trauma or neoplasm at injection site, hypersensitivity to corticosteroid, skin infection at site of infection
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the efficacy of 5% dextrose versus triamcinolone injection |
Both the groups will be assessed prior to injection and 1,3, and 6 weeks post injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| study the side effects and complications of drugs used |
during the follow up period of 6 weeks any complications related to drug administered |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/01/2024 |
| 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="2"
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
|
A randomised controlled study to assess the efficacy of 5% dextrose and triamcinolone in ultrasound guided median nerve block in patients of carpal tunnel syndrome refractory to conservative therapy.Carpal tunnel syndrome (CTS) is one of the most common focal
entrapment neuropathies. Although the exact etiology remains unclear,
high-pressure-related intracarpal tunnel compression of the median nerve (MN),
progressing ischemia, and mechanical strangulation are common mechanisms. The
therapeutic managements for CTS depend on the disease severity, varying from a
conservative treatment to surgical interventions. Surgical interventions are
recommended in severe cases or mild to moderate who fail to respond to conservative treatments.
Therefore, there is a need for a method to treat CTS without surgical interventions.
Different concentration of dextrose has been used, more
commonly 5% dextrose(D5W) is used as it has same osmolarity as of normal
saline. Additionally concentration upto 10% of D5W is used. . It is also hypothesized that dextrose in less
concentration decrease neurogenic inflammation.
Corticosteriod is most used for perineural injection under
blind or ultrasound guided technique in CTS patient. Possible adverse effects
of corticosteroids like myelin degeneration ,tendon
rupture, soft tissue atrophy, steroid flare and hot flushes. Perineural
injection using both D5W and corticosteroid were commonly used in clinical
practice for treating CTS
Therefore, we
designed the study with the aim to compare the effectiveness between 5%
dextrose and triamcinolone injection for mild to moderate cases of carpel
tunnel syndrome.
|