| CTRI Number |
CTRI/2023/06/054059 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
14/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Hydrodissection of carpal tunnel using normal saline] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
“Ultrasound guided hydrodissection versus surgical treatment for carpal tunnel syndrome: A Randomized Controlled Trial |
|
Scientific Title of Study
|
“Ultrasound guided hydrodissection versus surgical
carpal tunnel release 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 |
University College of Medical Sciences And GTB Hospital |
| Address |
Room no 1024 , Department of Radiodiagnosis , UCMS and GTB Hospital, Dilshad Garden , Delhi
JRD Hostel Room 218 , UCMS
East
DELHI
110095
India |
| Phone |
8178640853 |
| Fax |
|
| Email |
akankshasaini98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama Tandon |
| Designation |
Professor |
| Affiliation |
University College of Medical Sciences And GTB Hospital |
| Address |
Room 1007, Department of Radiodiagnosis, UCMS and GTB Hospital, Dilshad Garden , Delhi
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 |
University College of Medical Sciences And GTB Hospital |
| Address |
Room 1007, Department of Radiodiagnosis, UCMS and GTB Hospital, Dilshad Garden , Delhi
Room 1007,Department of Radiodiagnosis, UCMS and GTB Hospital, Dilshad Garden , Delhi
East
DELHI
110095
India |
| Phone |
8585977903 |
| Fax |
|
| Email |
anupamatandon@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Academic clinical trial being conducted at UCMS and GTB Hospital, Dilshad Garden, Delhi, Govt supply of normal saline , syringes, gloves being used which is available in hospital |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [Self] |
|
|
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, Delhi
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, DHR Registration no. EC/NEW/INST/2021/20 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G64||Other disorders of peripheral nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Surgical Release of Carpal tunnel |
Under local anaesthesia, approximately 2-3 cm long skin incision will be given along radial border of 4th
ray between distal wrist crease and Kaplan’s cardinal line. The subcutaneous tissue
will be cut in line of skin incision avoiding cutaneous nerves coming in the surgical
field. Self-retaining retractors will be placed and Transverse carpal ligament will be
exposed. Transverse carpal ligament will be incised using No. 15 knife/
19
Metzanbaum scissors and underlying carpal tunnel contents will be decompressed.
Tenosynovium will be examined for any inflammatory changes, floor of the carpal
tunnel will be checked for any ganglion/space occupying lesion and if the median
nerve is adherent to transverse carpal ligament or if there is Epineural thickening,
external neurolysis will be done, Skin closure will be done using monofilament nonabsorbable suture 3-0/4-0 (Nylon) using standard intermittent sutures. Standard
dressing without any splint will be given. Patient will be discharged after 4-6 hours.
|
| Intervention |
USG guided hydrodissection using normal saline |
Ultrasound transducer will be kept in the transverse plane of the
carpal tunnel. Median nerve will be identified as a hypoechoic structure. The transducer
will be moved ulnarly while keeping the median nerve in view. Palmaris longus and
ulnar artery will be identified. Procedure syringe will be loaded with 10ml of
hydrodissection fluid with Normal Saline.After appropriate sterile preparation the skin using betadine, 24 -gauge needle on the
procedure syringe will be inserted at 30 degree angle between the ulnar artery and the
ulnar border of Palmaris longus, penetrating the skin and subcutaneous tissue,
directed radially towards the median nerve, ensuring not to injure the median nerve.
5cc to 10cc (depending upon the completeness of the laminar separation) of the
18
hydrodissection fluid will be slowly injected under real time visualisation of the
laminar separation of the surrounding tissue of median nerve |
|
|
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. |
|
| ExclusionCriteria |
| Details |
Patients with other neurological causes like polyneuropathies, thoracic outlet
syndrome, cervical radiculopathy or secondary causes of carpal tunnel syndrome like
Ganglion cysts, accessory muscles etc
2. Patients who have received prior corticosteroid injection /carpal tunnel release
surgery.
3. Patients with thenar atrophy.
4. Patients with local site infection or any overlying skin lesions , scars or previous
history of Colles’ fracture.
5. Patients with uncontrolled diabetes / diabetic neuropathy , uncontrolled
hypothyroidism or bleeding diathesis or allergy to any local anaesthetic drug. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of improvement in BCTQ(SSS), BCTQ (FSS), VAS & CSA of median
nerve from pre procedure to post procedure in both groups. |
At 4 week, 8 week and whenever possible 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change from baseline of BCTQ (SSS), BCTQ (FSS) & VAS after hydrodissection
2. Change from baseline of BCTQ (SSS), BCTQ (FSS) & VAS after surgical release of
carpal tunnel.
3. Change from baseline of CSA of the median nerve using
ultrasound in both groups.
4. Comparison of complications between the two groups
5. Comparison of change in conduction velocity & latency in median nerve on NCS
from pre procedure to post procedure in both groups (whenever possible |
At 4 weeks, 8 weeks & whenever possible 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
01/07/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
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. Earlier surgery was preferred over conservative therapies in severe CTS cases. However there has been a recent shift towards minimally invasive and USG guided hydrodissection procedure which has shown positive long- term outcomes in CTS patients. No literature is available so far comparing the two treatment options . Hence this study is planned to compare effectiveness of USG guided hydrodissection and surgical carpal tunnel release for treatment of CTS. |