| CTRI Number |
CTRI/2025/07/091682 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of efficacy of nerve block by phenol vs botulinum toxin motor point block in case of post stroke upper limb tightness |
|
Scientific Title of Study
|
A comparative study between efficacy of phenol chemoneurolysis vs onabotulinum toxin motor point block in post stroke upper limb spasticity. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOUVIK MANDAL |
| Designation |
Junior resident |
| Affiliation |
IPGMER AND SSKM,KOLKATA |
| Address |
Uttarayan
Nutanchati
Christiandanga road
Bankura
ROOM NO 113
GROUND FLOOR
SSKM DOCTOR HOSTEL
242 HARISH MUKHERJEE ROAD,BHOWANIPUR,KOLKATA,WB 700020
Kolkata
WEST BENGAL
722101
India |
| Phone |
6290727376 |
| Fax |
|
| Email |
m.souvik339@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh Pramanik |
| Designation |
HOD and Professor |
| Affiliation |
IPGMER AND SSKM,KOLKATA |
| Address |
PMR DEPT,GROUND FLOOR,IPGMER AND SSKM
244,AJC Bose Road,kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9432594882 |
| Fax |
|
| Email |
rpramanik2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Pramanik |
| Designation |
HOD and Professor |
| Affiliation |
IPGMER AND SSKM,KOLKATA |
| Address |
PMR DEPT,GROUND FLOOR,IPGMER AND SSKM
244,AJC Bose Road,kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9432594882 |
| Fax |
|
| Email |
rpramanik2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| IPGMER & SSKM,KOLKATA
244 AJC Bose Road,kolkata 700020,India |
|
|
Primary Sponsor
|
| Name |
Institute of post graduate medical education and research |
| Address |
BHWANIPUR,KOLKATA
WEST BENGAL
700020 |
| 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 |
| SOUVIK MANDAL |
Institute of post graduate medical education and research |
PMR OT 1st FLOOR,PMR DEPT,244,AJC Bose Road,kolkata,WB
700020
Kolkata
WEST BENGAL |
6290727376
m.souvik339@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I699||Sequelae of unspecified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Botolinum toxin motor point block |
At first botulinum toxin prepared with ns.Then 5 cc needle inserted to motor point of each muscle with help of usg.Next toxin is injected into specific muscle |
| Intervention |
Phenol Chemoneurolysis |
At first teflon coated needle connected to nerve stimulator guided to specific motor branch of the muscle.Specific muscle contraction observed at 0.5 ma to 09.2 ma.Phenol injection given till no contraction visible |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Clinically and radiologically confirmed any stroke.
Spasticity at MAS scale 2/3.
Brunnstorm stage recovery 3-4 |
|
| ExclusionCriteria |
| Details |
Local site infection.
Contracture of UL.
Allergy to phenol or botulinum toxin |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Phenol block will be statistically significant than botulinum toxin in terms of MAS,wrist rom and modified frenchey scale |
Phenol block will be statistically significant than botulinum toxin in terms of MAS,wrist rom and modified frenchey scale at baseline,24 hr,2wk,12 wk |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
25/07/2025 |
| 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 - NO
|
|
Brief Summary
|
Patients are taken ,then routine blood tests, serology done . Patients are randomised into in a 1:1 ratio to a botulinum toxin injection group(A) or phenol injection group(B).Then grp A will be given botulinum toxin injection using usg guidance and grp B will be given phenol injection under nerve stimulator and usg guidance. Then patients are evaluated at 24 hr,2wk and 12 wk by assessing the wrist rom and value of modified frenchey scale. |