| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Proposals should be directed to email- anjali.kumari@kims.ac.in with proper reason.
- 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.
- 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.
|