| CTRI Number |
CTRI/2026/01/101210 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Clinical study effect of chemical neurolysis by phenol in lateral pectoral nerve for managing shoulder spasticity in cervical spine injury |
|
Scientific Title of Study
|
AN PROSPECTIVE INTERVENTIONAL STUDY TOFIND OUT THE EFFECTIVENESS OF USG GUIDED CHEMICAL NEUROLYSIS BY PHENOL IN LATERAL PECTORAL NERVE FOR MANAGING SHOULDER SPASTICITY IN CHRONIC CERVICAL SPINAL CORD INJURY PATIENTS,AT SMS MEDICAL COLLEGE AND HOSPITAL,JAIPUR |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kadam Rohit Raosaheb |
| Designation |
Resident |
| Affiliation |
Department of Physical Medicine and Rehabilitation,Rehabilitation Research centre building, SMS medical college,Jaipur |
| Address |
Department of Physical Medicine and Rehabilitation, Rehabilitation Research Centre building ,SMS medical college, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8554820672 |
| Fax |
|
| Email |
rkadam8080@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Astha Patni |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Physical Medicine and Rehabilitation,Rehabilitation Research centre building,SMS hospital, Jaipur
Department of Physical Medicine and Rehabilitation,Rehabilitation Research Centre building,SMS hospital
Jaipur
RAJASTHAN
302004
India |
| Phone |
8554820672 |
| Fax |
|
| Email |
drasthapatni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kadam Rohit Raosaheb |
| Designation |
Resident |
| Affiliation |
Department of Physical Medicine and Rehabilitation,Rehabilitation Research centre building, SMS medical college,Jaipur |
| Address |
Department of Physical Medicine and Rehabilitation,Rehabilitation Research Centre building,SMS college
Jaipur
RAJASTHAN
302004
India |
| Phone |
8554820672 |
| Fax |
|
| Email |
rkadam8080@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sawai Man singh medical college and hospital |
| Address |
Jawahar Lal Nehru Marg, Gangwal park , Adarsh nagar , Jaipur, Rajasthan,302004 |
| 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 |
| Kadam Rohit Raosaheb |
SMS medical college and Hospital |
Department Physical Medicine and Rehabilitation,Rehabilitation Research Centre,SMS college
Jaipur
RAJASTHAN |
8554820672
rkadam8080@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics committee, sms medical college and attached hospital,Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S129||Fracture of neck, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
USG guided chemical neurolysis by 6% aqueous phenol of lateral pectoral nerve |
Lateral pectoral nerve innervate pectoralis muscles , tightness of which result in shoulder spasticity usg guided neurolysis in supine patient with cerviacl spinal cord injury, targeting facial plane between pectoralis major and pectoralis minor with identification of thoracoacromial artery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
62.00 Year(s) |
| Gender |
Both |
| Details |
At least 3 month post cervical spinal cord injury
ASIA grade A to C with spasticity of grade 1+, 2 , 3 of modified Ashworth scale and grade 2, 3 , 4 of Australian spasticity assessment scale
Those who give written informed consent |
|
| ExclusionCriteria |
| Details |
Non traumatic spinal cord lesion
Pregnant and lactating females
Medical and surgical condition interfering with the assessment or intervention for study
Patient should not part of other study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in spasticity |
At baseline
At 2 week
At 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in range of motion |
At baseline
At 2 week
At 4 week |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/01/2026 |
| 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 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
|
Patients admitted in Department Of Physical Medical and Rehabilitation, Rehabilitation Research Centre and State Spinal Injury Centre,Sawai Mansingh Medical College and Attached Hospital,Jaipur , after cervical spinal cord injury with shoulder spasticity |