| CTRI Number |
CTRI/2024/02/062902 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Injections in shoulder for patients with long term shoulder pain
|
|
Scientific Title of Study
|
To compare efficacy of Glenohumeral with subacromial injections in patient with chronic shoulder pain
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashi Kiran |
| Designation |
Senior Professor |
| Affiliation |
Department Of Anesthesia and Critical Care PGIMS Rohtak |
| Address |
Room No. 4, Department Of Anesthesia and Critical Care PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416763899 |
| Fax |
|
| Email |
drshashi64@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Verma |
| Designation |
Junior Resident |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Anesthesiaand Critical Care PGIMS ROhtak
Rohtak
HARYANA
124001
India |
| Phone |
8295444434 |
| Fax |
|
| Email |
verma.mbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Verma |
| Designation |
Junior Resident |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Anesthesiaand Critical Care PGIMS ROhtak
Rohtak
HARYANA
124001
India |
| Phone |
8295444434 |
| Fax |
|
| Email |
verma.mbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Critical Care Post Graduate Institute of Medical Sciences Rohtak |
|
|
Primary Sponsor
|
| Name |
PGIMS Rohtak |
| Address |
PT.B.D. Sharma PGIMS Rohtak |
| 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 Shashi Kiran |
PGIMS Rohtak |
Room No. 4 Department of Anaesthesia and Critical Care
Rohtak
HARYANA |
941676899
drshashi64@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B.D. Sharma PGIMS/UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Glenohumeral Joint |
Single Injection of 9 ml of 0.5% Bupivacaine and 1 ml (40 mg) Triamcinolone acetonide intraarticularly in glenohumeral joint to be injected within 5 minutes |
| Comparator Agent |
Subacromial Joint |
Single Injection of 9 ml of 0.5% Bupivacaine and 1 ml (40 mg) Triamcinolone acetonide in subacromial space of shoulder joint within 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of 20-70 years of age of either sex coming to pain clinic suffering from chronic shoulder pain. |
|
| ExclusionCriteria |
| Details |
Patients with known contraindication for block interventions (e. g. infection at site of block, coagulopathy etc), history of adverse reaction to steroids or bupivacaine, uncontrolled Diabetes mellitus and patients suffering from rotator cuff injuries, fracture shoulder joint |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Following parameters will be recorded to determine effectiveness:
- Pain
- Range of motion
|
30 Minutes
1 week
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SPADI ( Shoulder Pain And Disability Score) |
30 Minutes
1 week
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="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
|
Primary objective : To assess the effectiveness of glenohumeral and subacromial space injection with corticosteroid and local anaesthetic agent in alleviating the pain in patient with chronic shoulder pain. . Secondary objective : To assess the effectiveness of glenohumeral and subacromial space injection with corticosteroid and local anaesthetic agent in improvement of range of motion in the patients with chronic shoulder pain |