| CTRI Number |
CTRI/2024/06/068263 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
02/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Prospective non Randomized Comparative Study] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing pain relief afree Ultrasound guided Suprascapular Nerve Block vs Neuromodulation of Suprascapular Nerve in patients with rigid shoulder. |
|
Scientific Title of Study
|
Comparison of Ultrasound guided Suprascapular Nerve Block with Lignocaine and Triamcinolone and Pulsed Radiofrequency Neuromodulation of Suprascapular Nerve Block for Pain relief in patients with Adhesive Capsulitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Rajain |
| Designation |
PG Anaesthesia |
| Affiliation |
Atal Bihari Vajpayee Institute Of Medical sciences and Dr Ram Manohar Lohia Hospital, New Delhi |
| Address |
Room no 304 Department of Anaesthesia, PGI Building Atal Bihari Vajpayee Institute Of Medical sciences and Dr Ram Manohar Lohia Hospital, New Delhi
Central
DELHI
110001
India |
| Phone |
9717160216 |
| Fax |
|
| Email |
nidhi.rajains98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilesh Gupta |
| Designation |
Professor |
| Affiliation |
Atal Bihari Vajpayee Institute Of Medical sciences and Dr Ram Manohar Lohia Hospital, New Delhi |
| Address |
Room no 304, Department of Anaesthesia PGI Building, Atal Bihari Vajpayee Institute Of Medical sciences and Dr Ram Manohar Lohia Hospital, New Delhi
Central
DELHI
110001
India |
| Phone |
9810685426 |
| Fax |
|
| Email |
drakhileshgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhilesh Gupta |
| Designation |
Professor |
| Affiliation |
Atal Bihari Vajpayee Institute Of Medical sciences and Dr Ram Manohar Lohia Hospital, New Delhi |
| Address |
Room No. 304, Department of Anaesthesia PGI Building , Atal Bihari Vajpayee Institute Of Medical sciences and Dr Ram Manohar Lohia Hospital, New Delhi
Central
DELHI
110001
India |
| Phone |
9810685426 |
| Fax |
|
| Email |
drakhileshgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Atal Bihari Vajpayee Institute Of Medical sciences and Dr Ram Manohar Lohia Hospital, New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML Hospital |
| Address |
Baba Kharak Singh Road, near Gurudwara Bangla sahib, Ram Manohar Lohia Hospital, new delhi |
| 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 Nidhi Rajain |
ABVIMS and Dr. RML Hospital, New Delhi |
Room no 304 Department of Anaesthesia PI Building,ABVIMS and Dr. RML Hospital, Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi
Central
DELHI |
9717160216
nidhi.rajains98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Suprascapular Nerve Block vs Neuromodulation of Suprascapular Nerve |
Comparing Ultrasound guided Suprascapular nerve Block with lignocaine and triamcinolone and Pulsed Radiofrequency Neuromodulation of Suprascapular Nerve Block for pain relief in patients with Adhesive Capsulitis just after post procedure , at first week , first month, second month and third month of follow up . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA CLASS 1 and 2 |
|
| ExclusionCriteria |
| Details |
Pre-existing neurological deficit, Coagulation disorders, Local infection at site of procedure, Allergic to local anaesthetic agent, Patients with Rheumatoid and Osteoarthritis causing Shoulder pain |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare post procedure pain relief using Numerical Rating Scale |
At 0 day, 7 day, 30 days, 60 days, 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare decrease in disability using Shoulder Pain & Disability Index |
At 0, 7 days, 30 days, 60 days , 90 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
13/06/2024 |
| 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="1"
Months="5"
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
|
This Prospective Randomized, Comparative study done in Department of Anaesthesia, ABVIMS and Dr. RML hospital to compare Ultrasound guided Suprascapular Nerve Block with lignocaine and Triamcinolone and Pulsed Radiofrequency Neuromodulation of Suprascapular nerve for pain relief in patients with Adhesive Capsulitis. The pain relief is measured by Numerical Rating Score and post procedure improved disability is assess by Shoulder Pain and Disability Index in recovery room immediately after the procedure and again assessed in OPD up to three months at regular intervals. |