| CTRI Number |
CTRI/2026/01/102488 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Preventive Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Dextrose versus Triamcinolone Injection for Carpal Tunnel Syndrome Relief |
|
Scientific Title of Study
|
A Randomized Controlled Trial Comparing the Efficacy of Five Percent Dextrose and Triamcinolone Hydrodissection 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 Ravi Gaur |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences Jodhpur |
| Address |
Room 15 PMR Block AIIMS Jodhpur Near OPD Complex Heavy Industrial Area Phase II Basni Jodhpur Rajasthan
Jodhpur RAJASTHAN 342005 India |
| Phone |
8299711753 |
| Fax |
|
| Email |
ravisms80@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ravi Gaur |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences Jodhpur |
| Address |
Room 15 PMR Block AIIMS Jodhpur Near OPD Complex Heavy Industrial Area Phase II Basni Jodhpur Rajasthan
RAJASTHAN 342005 India |
| Phone |
8299711753 |
| Fax |
|
| Email |
ravisms80@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ravi Gaur |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences Jodhpur |
| Address |
Room 15 PMR Block AIIMS Jodhpur Near OPD Complex Heavy Industrial Area Phase II Basni Jodhpur Rajasthan
RAJASTHAN 342005 India |
| Phone |
8299711753 |
| Fax |
|
| Email |
ravisms80@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur ,marudar hi industrial area second phase, Basni, Jodhpur, Rajasthan 342005 |
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
PMR Block , AIIMS Jodhpur ,marudar hi industrial area second phase, Basni, Jodhpur, Rajasthan 342005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ujwal Veluguleti |
AIIMS Jodhpur |
PMR Block Room 15 , Marudar Hi Industrial Area, Second Phase, Basni, Jodhpur, Rajasthan 342005 Jodhpur RAJASTHAN |
9581881995
veluguletiujwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE, All India Institute of Medical Sciences Basni Jodhpur |
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 |
Ultrasound guided median nerve hydrodissection using five percent dextrose.
|
Dextrose group will receive a single 10 millilitre perineural injection prepared by mixing 2 millilitres of 25 percent dextrose, 3 millilitres of 2 percent lidocaine, and 5 millilitres of normal saline. The injection will be administered once under ultrasound guidance for hydrodissection of the median nerve at the carpal tunnel inlet using an in-plane ulnar approach with a 26-gauge needle. Five millilitres of the injectate will be delivered above the median nerve to separate it from the flexor retinaculum and five millilitres below the nerve to separate it from the flexor tendons. Total duration of intervention: single session; follow-up assessments at 1 and 3 months. |
| Comparator Agent |
Ultrasound guided median nerve hydrodissection using forty milligrams per milliliter triamcinolone acetate. |
Triamcinolone group will receive a single 10 millilitre perineural injection prepared by mixing 1 millilitre of triamcinolone acetonide 40 milligrams per millilitre, 3 millilitres of 2 percent lidocaine, and 6 millilitres of normal saline. The injection will be administered once under ultrasound guidance for hydrodissection of the median nerve at the carpal tunnel inlet using an in-plane ulnar approach with a 26-gauge needle. Five millilitres will be injected above the nerve and five millilitres below. Total duration of intervention: a single session, with follow-up assessments at 1 and 3 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies and meeting the following criteria.
Primary symptom includes nocturnal paresthesia or dysesthesia in the affected hand, possibly associated with hand posture, overuse, or relief by shaking the hand, also known as the flick sign.
At least one of the following features must be present.
Numbness in the median nerve sensory distribution of the hand.
Weakness with atrophy of the thenar muscles.
Positive Phalen’s sign or Tinel’s sign. |
|
| ExclusionCriteria |
| Details |
Pre existing neurological conditions such as polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
Recent wrist surgery.
Inflammatory conditions such as rheumatoid arthritis, hypothyroidism, or other rheumatological disorders.
Pregnancy.
Uncontrolled diabetes mellitus.
Current warfarin use or previous steroid injections at the wrist.
Any trauma, tumor, or infection at the injection site.
Allergy to corticosteroids or lidocaine. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analog scale (VAS) |
base line 1 month and 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| boston carpal tunnel questionnaire |
base line 1 month and 3 month |
| cross sectional area of median nerve in ultrasound |
base line 1 month 3 month |
| nerve conduction studies |
base line 1 month and 3 month |
| grip strength of hand |
base line 1 month and 3 month |
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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 4 |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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="9" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Carpal Tunnel Syndrome is the most common entrapment neuropathy resulting from compression of the median nerve within the carpal tunnel, leading to pain, numbness, and weakness in the hand. Hydrodissection, an ultrasound guided technique, separates the median nerve from surrounding tissues to relieve compression and improve nerve mobility. This double blind randomized controlled trial aims to compare the efficacy of five percent dextrose in water and triamcinolone forty milligrams per milliliter hydrodissection in patients with mild to moderate Carpal Tunnel Syndrome. A total of 110 participants, 55 in each group, will be recruited from the Department of Physical Medicine and Rehabilitation at the All India Institute of Medical Sciences, Jodhpur. Group A will receive a 10 milliliter injectate of five percent dextrose in water, consisting of 2 milliliters of 25 percent dextrose, 3 milliliters of two percent lidocaine, and 5 milliliters of normal saline. Group B will receive 10 milliliters of triamcinolone preparation, consisting of 1 milliliter triamcinolone, 3 milliliters of two percent lidocaine, and 6 milliliters of normal saline. Injections will be performed under ultrasound guidance using an in plane ulnar approach. Outcomes including pain score using visual analog scale, Boston Carpal Tunnel Syndrome Questionnaire, ultrasound measured cross sectional area, nerve conduction studies, and grip strength will be assessed at baseline, 1 month, and 3 months. Five percent dextrose in water hydrodissection is hypothesized to provide longer lasting pain relief and functional improvement compared to triamcinolone. |