| CTRI Number |
CTRI/2024/10/075028 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect of ultrasound guided median nerve release through hydrodissection using dextrose and normal saline for treatment of carpal tunnel syndrome |
|
Scientific Title of Study
|
Comparison of ultrasound guided hydrodissection with dextrose versus normal saline for treatment of carpal tunnel syndrome: A Randomized Controlled Trial |
| 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 Akanksha Saini |
| Designation |
Postgraduate Resident |
| Affiliation |
Department of Radiodiagnosis, UCMS and GTB Hospital, Dilshad Garden, Delhi |
| Address |
Room no 1024, Department of Radiodiagnosis, UCMS and GTB Hospital, Dilshad Garden, Delhi
East
DELHI
110095
India |
| Phone |
8178640853 |
| Fax |
|
| Email |
akankshasaini98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama Tandon |
| Designation |
Professor |
| Affiliation |
Department of Radiodiagnosis, UCMS and GTB Hospital, Dilshad Garden, Delhi |
| Address |
Room 1007, Department of Radiodiagnosis, UCMS and GTB Hospital, Dilshad Garden, Delhi
East
DELHI
110095
India |
| Phone |
8585977903 |
| Fax |
|
| Email |
anupamatandon@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupama Tandon |
| Designation |
Professor |
| Affiliation |
Department of Radiodiagnosis, UCMS and GTB Hospital, Dilshad Garden, Delhi |
| Address |
Room 1007, Department of Radiodiagnosis, UCMS and GTB Hospital, Dilshad Garden, Delhi
DELHI
110095
India |
| Phone |
8585977903 |
| Fax |
|
| Email |
anupamatandon@hotmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and GTB Hospital, Delhi-110095 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Akanksha Saini |
UCMS and GTB Hospital , Delhi |
Room no 18 , Department of Radiodiagnosis, UCMS and GTB Hospital
East
DELHI |
8178640853
akankshasaini98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Human Research (IEC-HR) UNIVERSITY COLLEGE OF MEDICAL SCIENCES , UNIVERSITY OF DELHI, DELHI-110095 |
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 |
Hydrodissection using 5%dextrose |
Median nerve will be identified using USG.
5cc to 10 cc of 5% dextrose (depending upon the completeness of the laminar separation) will be slowly injected under real time visualisation of the laminar separation of the surrounding tissue of median nerve at level of carpal tunnel
. It is a one time procedure only. Patient will then be followed up for 6 months. |
| Comparator Agent |
Hydrodissection using normal saline |
Median nerve will be identified using USG.
5cc to 15cc of normal saline (depending upon the completeness of the laminar separation) will be slowly injected under real time visualisation of the laminar separation of the surrounding tissue of median nerve at level of carpal tunnel. It is a one time procedure only. Patient will then be followed up for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients having NCS proven carpal tunnel syndrome with persistent symptoms not resolving after 6-8 weeks of medications or splinting referred from orthopaedics department for hydrodissection |
|
| ExclusionCriteria |
| Details |
: Patients with other neurological causes like polyneuropathies, thoracic outlet syndrome, cervical radiculopathy; secondary causes like ganglion cysts, accessory muscles; received prior steroid injection / carpal tunnel release surgery ; thenar atrophy; local site infection , history of Colles’ fracture; uncontrolled diabetes / diabetic neuropathy , uncontrolled hypothyroidism or bleeding diathesis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of improvement in BCTQ(SSS), BCTQ (FSS), VAS and CSA of median nerve from pre procedure to post procedure in both groups. |
At 1 month , 3 month and wherever possible 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change from baseline of BCTQ (SSS), BCTQ (FSS) and VAS after ultrasound guided hydrodissection with 5% dextrose .
2. Change from baseline of BCTQ (SSS), BCTQ (FSS) and VAS after ultrasound guided hydrodissection with normal saline .
3. Change from baseline of cross-sectional area (CSA) of the median nerve using ultrasound in both groups.
4. Comparison of complications between the two injectate groups (expressed as %).
|
At 1 month , 3 month and wherever possible 6 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/10/2024 |
| 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="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is most common peripheral neuropathy.Traditionally,
conservative management with drugs and splinting is
the mainstay of treatment. With
encouraging outcomes, there has been a change in recent years towards minimally
invasive and image guided procedure ie Hydrodissection.NS
has shown good results in mild to moderate CTS by causing adhesiolysis
around median nerve and is superior to steroid injection, hence it has been routinely used for treatment in several institutions. Several injectates have been studied after this out of which dextrose was found to be superior due to its proposed additional effects on certain receptors like nociceptive
C-fibres, AMPK enzyme, TNF alpha, TRPV-1
receptors. However no consensus in literature about optimal injectate to be used is available so far .Thus,
this study was planned to compare the efficacy of hydrodissection with
dextrose and normal saline. |