CTRI Number |
CTRI/2023/07/055440 [Registered on: 20/07/2023] Trial Registered Prospectively |
Last Modified On: |
20/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Is there any difference between short axis and combined short and long axis approach of median nerve hydrodissection in patients of carpal tunnel syndrome? |
Scientific Title of Study
|
A Randomised controlled study comparing short axis and combined short and long axis median nerve 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 |
Sakshi Bhardwaj |
Designation |
First year resident |
Affiliation |
Lady Hardinge Medical College |
Address |
Department of Anesthesia, Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place , New Delhi, Central Delhi , 110001
Central DELHI 110001 India |
Phone |
8708770291 |
Fax |
|
Email |
sakshirules12@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Nitin Hayaran |
Designation |
Professor |
Affiliation |
Lady Hardinge Medical College |
Address |
Department of Anesthesia, Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place , New Delhi, Central Delhi
Central DELHI 110001 India |
Phone |
9873903603 |
Fax |
|
Email |
nhayaran97@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Sakshi Bhardwaj |
Designation |
First year resident |
Affiliation |
Lady Hardinge Medical College |
Address |
Department of Anesthesia, Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place , New Delhi, Central Delhi
Central DELHI 110001 India |
Phone |
8708770291 |
Fax |
|
Email |
sakshirules12@gmail.com |
|
Source of Monetary or Material Support
|
Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place , New Delhi, Central Delhi, 110001 |
|
Primary Sponsor
|
Name |
Lady Hardinge Medical College and associated hospitals |
Address |
Shaheed Bhagat Singh Road, Connaught Place , New Delhi , 11001 |
Type of Sponsor |
Government 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 |
Dr Sakshi Bhardwaj |
Lady Hardinge Medical College and associated hospitals |
Department of Anesthesia, Pain Clinic, Smt Sucheta Kriplani Hospital, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place , New Delhi, Central Delhi , 110001 Central DELHI |
8708770291
sakshirules12@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
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 |
Group B - Combined short and long axis approach. |
Group B - Patients in group B will be subjected to ultrasound guided median nerve hydrodissection using combined short and long axis approach. |
Comparator Agent |
Hydrodissection using short axis approach |
Hydrodissection using combined short and long axis approach |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
All adult patients diagnosed with Carpal Tunnel Syndrome based on clinical criteria and Nerve Conduction Velocity studies. |
|
ExclusionCriteria |
Details |
1) A previous history of wrist surgery,polyneuropathy,brachial plexopathy, or thoracic outlet syndrome.
2) Previous steroid injection for Carpal Tunnel Syndrome in the last 3 months.
3) Patients with grade 5 and grade 6 Carpal Tunnel Syndrome according to Blands neurophysiological grading of carpal tunnel syndrome. |
|
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 |
Percentage change in median Boston Carpal Tunnel Severity Questionnaire (BCTSQ) score at 3 months from baseline after ultrasound guided hydrodissection of median nerve in both the groups. |
At baseline and at the end of 3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Change in the mean cross sectional diameter of the median nerve calculated using ultrasonographic evaluation in both the groups at the end of 3 months. |
At the end of 3 months |
Difference in median Nerve Conduction Velocity (NCV) grade in both the groups at the end of 3 months. |
At the end of 3 months |
|
Target Sample Size
|
Total Sample Size="78" Sample Size from India="78"
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 3/ Phase 4 |
Date of First Enrollment (India)
|
28/07/2023 |
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="3" Days="10" |
Recruitment Status of Trial (Global)
|
Not Applicable |
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
|
Study will be conducted after the approval by the Institutional Ethics Committee and will be registered in the Clinical Trials Registry- India (CTRI). Patients will be chosen for the study keeping in mind the inclusion and exclusion criteria. A careful checkup including detailed history with special emphasis on characteristic signs and symptoms of CTS, physical examination, clinical tests which include provocative maneuvers like Phalen test, Tinel test, Durkan test, Upper limb neurodynamic test, hand elevation test and electrodiagonostic test(NCV) will be done. Patients will be classified on the basis of Blands neurophysiological grading of CTS 12 (Annexure – IV). A written informed voluntary consent will be taken from the patient after carefully explaining the procedure, its benefits and risks and alternative therapies in patient’s own language. Median nerve diameter will be assessed in all the patients using ultrasonographic evaluation. All patients will be explained about the Boston Carpal Tunnel Severity Questionnaire (BCTSQ, Annexure – III). Baseline BCTSQ score will be taken in patients before procedure. Patients will be shifted to procedure room and standard monitoring will be applied, including pulse oximetery, electrocardiography and noninvasive blood pressure. Randomisation An investigator with no further involvement in the study will generate a list ofrandom numbers between 01-100 in varying block sizes using an online computer randomization service (Research Randomizer www.Randomizer.org). The unique randomization code will be allocated and used to randomize consenting participant patients equally with no restrictions or bias to either of the two study groups: short axis group (A) or combined short and long axis group (B). ​ Allocation Concealment The results of the allocation will be concealed in sequentially numbered sealed opaque envelopes mentioning the code and group number . These envelopes with results of allocation will not be seen by the research coordinator prior to sealing and will only be kept by the coordinator after sealing. On the day of procedure, the coordinator will hand over an envelope to the principal investigator. The approach for the procedure will be decided by the group mentioned in the envelope. Case record sheet filled subsequently will only mention the randomized code with no reference to the approach or group number noted. For group A (Short axis approach) - The needle and probe are both perpendicular to the nerve. The needle is in plane to the transducer and the soft tissues below the nerve are first hydrodissected (with the needle bevel facing up) followed by hydrodissection of soft tissues above the nerve (with the needle bevel facing down). For group B (Combined short and long axis approach) - First the needle and probe are both perpendicular to the nerve and hydrodissection is done similar to the short axis approach. Subsequently both the transducer and needle are turned parallel to the nerve and soft tissue below and above the nerve are hydrodissected. This allows us to hydrodissect a long segment of the nerve in both proximal and distal direction. The injectate used in both the situations is 20ml of 5% dextrose with water.
Serious adverse events (such as swelling, pain, bleeding, increased paresthesia or numbness, injury to neighbouring neurovascular structures) will be noted, managed and reported to the IEC within 24 hours. |