| CTRI Number |
CTRI/2024/11/077262 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Onabotulinum toxin type A injection and Phenol injection in improving post stroke spasticity and walking ability. |
|
Scientific Title of Study
|
Comparative study on improvement in gait between between 6% phenol chemoneurolysis and onabotulinum toxin type A in post stroke 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 |
SHEEZAN PERWEZ |
| Designation |
Post Graduate Trainee |
| Affiliation |
IPGMER AND SSKM |
| Address |
OPD room no.1, Dept of PMR, IPGMER AND SSKM HOSPITAL
AJC BOSE ROAD, BHOWANIPUR,
KOLKATA, WEST BENGAL
Kolkata
WEST BENGAL
700020
India |
| Phone |
9654264161 |
| Fax |
|
| Email |
SHEEZANP@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
RAJESH PRAMANIK |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
IPGMER AND SSKM |
| Address |
DEPARTMENT OF PHYSICAL MEDICINE AND REHABILITATION, IPGMER AND SSKM HOSPITAL, AJC BOSE ROAD, BHOWANIPUR, KOLKATA, WEST BENGAL
Kolkata
WEST BENGAL
700020
India |
| Phone |
9874690505 |
| Fax |
|
| Email |
RPRAMANIK2000@YAHOO.COM |
|
Details of Contact Person
Public Query
|
| Name |
RAJESH PRAMANIK |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
IPGMER AND SSKM |
| Address |
DEPARTMENT OF PHYSICAL MEDICINE AND REHABILITATION, IPGMER AND SSKM HOSPITAL, AJC BOSE ROAD, BHOWANIPUR, KOLKATA, WEST BENGAL
Kolkata
WEST BENGAL
700020
India |
| Phone |
9874690505 |
| Fax |
|
| Email |
RPRAMANIK2000@YAHOO.COM |
|
|
Source of Monetary or Material Support
|
| IPGMER AND SSKM HOSPITAL, AJC Bose road, Bhowanipore, Kolkata, West Bengal 700020 |
|
|
Primary Sponsor
|
| Name |
IPGMER AND SSKM HOSPITAL |
| Address |
IPGMER AND SSKM HOSPITAL, AJC BOSE ROAD, BHOWANIPUR, KOLKATA, WEST BENGAL |
| 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 |
| SHEEZAN PERWEZ |
IPGMER AND SSKM HOSPITAL |
OPD Room No.1, Dept of PMR, IPGMER AND SSKMH,AJC BOSE ROAD, BHOWANIPORE, KOLKATA, WEST BENGAL
Kolkata
WEST BENGAL |
9654264161
SHEEZANP@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I693||Sequelae of cerebral infarction, (2) ICD-10 Condition: I692||Sequelae of other nontraumatic intracranial hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chemoneurolysis with 6% phenol |
Chemoneurolysis using 6% phenol in posterior tibial nerve/ branches visualized under USG and/or Nerve stimulator, MAS for spasticity improvement and gait analysis for improvement in gait parameters will be done at 24 hrs, 3 weeks and 12 weeks |
| Comparator Agent |
Intramuscular injection of onabotulinum toxin type A |
Onabotulinum type A injection in Gastrocnemius/ tibialis posterior, under USG guidance, MAS for spasticity improvement and gait analysis for improvement in gait parameters will be done at 24 hrs , 3 weeks and 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically and radiologically diagnosed first ever stroke
2. Age of the patient 20-65 (19) years irrespective of gender.
3. 3 months after onset of stroke
4. Spasticity at resting state of Gastrocnemius, soleus, tibialis
posterior muscle as defined by MAS scale of 2/3.
5. Brunnstrom recovery stage III-IV
6. MMSE score ≥ 25
7. Consent from the patient. |
|
| ExclusionCriteria |
| Details |
1. Other neurological disorder
2.Sensory impairment
3. Osteoarticular disease
4. Past H/O Botox or Phenol injection.
5. MAS ≤1 + , Adductor muscle spasticity
6. Local site infection
7.No contracture of lower limb or previous surgery for spasticity
contracture.
8. Allergy to botulinum toxin type A or Phenol
9. Abnormal coagulation profile
10.Patients suffering from unstable cardio vascular or
serious respiratory diseases
11. Pregnancy or breastfeeding |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in modified ashworth scale , step length, cadence, gait speed, stance phase, swing phase |
Pre procedure, 24 hours, 3 weeks , 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in modified ashworth scale , step length, cadence, gait speed, stance phase, swing phase |
pre procedure, Day 3, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/12/2024 |
| 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="0"
Months="9"
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
|
To asses any improvement in Gait assessment parameters, Modified Ashworth Scale before and after application of Phenol 6% injection to Posterior tibial nerve/ branches • To asses any improvement in Gait assessment parameters, Modified Ashworth Scale before and after application of Onabotulinum Toxin A in Gastrocnemius /Tibialis posterior muscle. • To compare improvement in both these groups using Gait assessment parameters, step length, cadence, gait speed, swing phase, stance phase, MAS |