FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/095537 [Registered on: 01/10/2025] Trial Registered Prospectively
Last Modified On: 01/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study comparing one versus two ultrasound-guided injections for carpal tunnel syndrome 
Scientific Title of Study   Comparative analysis of single versus double injection ultrasound-guided perineural hydrodissection of the median nerve in carpal tunnel syndrome: a randomised 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  Anjali Kumari 
Designation  Assistant Professor 
Affiliation  Kalinga institute of medical sciences, Bhubaneshwar 
Address  3rd floor Main OT complex, Department of Anesthesiology and Pain Medicine, Kalinga institute of medical sciences, KIIT deemed-to-be university, Bhubaneshwar, Khorda

Khordha
ORISSA
751024
India 
Phone  9007474943  
Fax    
Email  anjali.kumari@kims.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Anjali Kumari 
Designation  Assistant Professor 
Affiliation  Kalinga institute of medical sciences, Bhubaneshwar 
Address  3rd floor Main OT complex, Department of Anesthesiology and Pain Medicine, Kalinga institute of medical sciences, KIIT deemed-to-be university, Bhubaneshwar, Khorda

Khordha
ORISSA
751024
India 
Phone  9007474943  
Fax    
Email  anjali.kumari@kims.ac.in  
 
Details of Contact Person
Public Query
 
Name  Anjali Kumari 
Designation  Assistant Professor 
Affiliation  Kalinga institute of medical sciences, Bhubaneshwar 
Address  3rd floor Main OT complex, Department of Anesthesiology and Pain Medicine, Kalinga institute of medical sciences, KIIT deemed-to-be university, Bhubaneshwar, Khorda

Khordha
ORISSA
751024
India 
Phone  9007474943  
Fax    
Email  anjali.kumari@kims.ac.in  
 
Source of Monetary or Material Support  
Kalinga institute of medical sciences, KIIT deemed-to-be university, Bhubaneshwar, Khorda, Odisha, India PIN-751024 
 
Primary Sponsor  
Name  Anjali Kumari 
Address  Department of Anesthesiology and Pain Medicine, Kalinga institute of medical sciences, KIIT deemed-to-be university, Bhubaneshwar, Khorda, Odisha, India PIN-751024 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anjali Kumari  Kalinga institute of medical sciences, KIIT deemed-to-be university, Bhubaneshwar, 751024  Pain Clinic, KIMS Superspeciality block
Khordha
ORISSA 
9007474943

anjali.kumari@kims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kalinga Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G560||Carpal tunnel syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A (Single injection)  Participants in this group will receive one ultrasound-guided injection of 10 mL of 5% dextrose around the median nerve in carpal tunnel. The injectate will be given slowly over 5-10 minutes, observing the hydrodissection around the nerve.  
Intervention  Group B (Double injection)  Participants in this group will receive two ultrasound-guided injections of 10 mL of 5% dextrose around the median nerve in carpal tunnel, with the second injection given 4 weeks after the first. The injectate will be given slowly over 5-10 minutes, observing the hydrodissection around the nerve. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Clinical diagnosis of mild to moderate CTS (based on symptoms, nerve conduction study and median nerve cross-sectional area on ultrasound examination)
Symptom duration more than 3 months
Able to provide informed consent 
 
ExclusionCriteria 
Details  Previous carpal tunnel surgery
Severe CTS (denervation changes on EMG)
Other upper limb neuropathies or thoracic outlet syndrome, cervical radiculopathy or brachial plexopathy
Coagulopathy or anticoagulant use
Previous corticosteroid injection in the affected wrist within 6 months
Pregnancy or lactation
Systemic diseases such as thyroid disorders, rheumatoid arthritis, diabetes mellitus, chronic renal failure 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain score as measured by numerical pain rating scale (NRS)   At baseline, 4, 12, and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Boston carpal tunnel syndrome questionnaire symptom severity score (BCTQ SSS)  At baseline, 4, 12, and 24 weeks 
Median nerve cross-sectional area at pisiform level on ultrasonography  At baseline, 4, 12, and 24 weeks 
Patient satisfaction (Likert scale)  At 4, 12, and 24 weeks 
Nerve conduction study parameters (distal motor latency, sensory latency, sensory conduction velocity)  At baseline and 24 weeks 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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   N/A 
Date of First Enrollment (India)   15/10/2025 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals should be directed to email- anjali.kumari@kims.ac.in with proper reason.

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Carpal tunnel syndrome (CTS) is the most prevalent entrapment neuropathy, caused by compression of the median nerve beneath the transverse carpal ligament at the wrist. Thickening and fibrosis of the subsynovial connective tissue (SSCT) contribute to restricted movement of the median nerve within the carpal tunnel. Cadaveric studies have shown that hydrodissection decreases gliding resistance of the median nerve by mechanically releasing these adhesions.

Standard non-surgical management includes wrist splinting, NSAIDs, activity modification, local corticosteroid injections, and physiotherapy. Recently, ultrasound-guided hydrodissection has emerged as a minimally invasive intervention in which targeted fluid injection (normal saline, D5W, platelet-rich plasma, hyaluronic acid) is used to physically separate the median nerve from the SSCT and flexor retinaculum, reducing compression and restoring nerve mobility. The injectate creates a perineural plane, mechanically loosening adhesions and improving nerve gliding.

A 2021 systematic review of randomised trials concluded that ultrasound-guided hydrodissection is safe and potentially effective for CTS but emphasised that optimal parameters like injectate type, volume, and frequency, remain undefined. A 2024 network meta-analysis found that D5W produced the most consistent improvement in symptoms and function at 4, 12, and 24 weeks.

Despite this growing body of research, no high-quality studies have directly compared single-injection with multiple-injection (“double-injection”) hydrodissection protocols. Given that adhesions may reform between sessions, repeated hydrodissection could theoretically yield more durable symptom relief. This evidence gap provides the rationale for the present study, which aims to compare the clinical and functional outcomes of double-injection versus single-injection ultrasound-guided hydrodissection in mild to moderate CTS.


 
Close