| CTRI Number |
CTRI/2024/02/063029 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to check effect of intra articular saline injection with corticosteroids and Corticosteroid aloneInjection in Adhesive Capsulitis of the Shoulder. |
|
Scientific Title of Study
|
“Comparative Study of Ultrasonography guided Hydrodilation and Intra-articular Corticosteroid Injection in Adhesive Capsulitis of the Shoulder.†|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushboo Dhameliya |
| Designation |
Assistant professor,md anaesthesiology |
| Affiliation |
Gmers medical college,junagadh |
| Address |
Department of anaesthesiology,room number-310,gmers medical college and hospital,junagadh,mulawada road,majewadi gate
Junagadh
GUJARAT
362001
India |
| Phone |
9408054469 |
| Fax |
|
| Email |
khushbudhameliya61@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Khushboo Dhameliya |
| Designation |
Assistant professor,md anaesthesiology |
| Affiliation |
Gmers medical college,junagadh |
| Address |
Department of anaesthesiology,room number-310,gmers medical college and hospital,junagadh,mulawada road,majewadi gate
Junagadh
GUJARAT
362001
India |
| Phone |
9408054469 |
| Fax |
|
| Email |
khushbudhameliya61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Khushboo Dhameliya |
| Designation |
Assistant professor,md anaesthesiology |
| Affiliation |
Gmers medical college,junagadh |
| Address |
Department of anaesthesiology,room number-310,gmers medical college and hospital,junagadh,mulawada road,majewadi gate
Junagadh
GUJARAT
362001
India |
| Phone |
9408054469 |
| Fax |
|
| Email |
khushbudhameliya61@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gmers medical college,junagadh |
|
|
Primary Sponsor
|
| Name |
Khushboo Dhameliya |
| Address |
Department of Anesthesiology,room number-310,GMERSs medical college and hospital,Junagadh,mulawada,near majewadi gate |
| 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 Khushbu dhameliya |
Orthopedic operation theatre |
307,3rd floor,orthopedic operation theatre,gmers medical college and hospital Junagadh
Junagadh
GUJARAT |
9408054469
Khushbudhameliya61@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee gmers medical college Junahadh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M659||Synovitis and tenosynovitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Corticosteroid injection in shoulder joint capsule |
Under usg guidance 22 gauge stimuplex needle will be inserted in shoulder joint entering from posterior glenohumeral approach and 2cc triamcinolone(80mg) and 2 cc ropivacaine 0.2% and 1 ml of ns,total volume of 5 ml will be given |
| Intervention |
Hydrodilation of shoulder joint capsule |
Under usg guidance 22gauze stimuplex needle will be inserted in shoulder joint capsule with posterior glenohumeral approach in 2cc triamcinolone acetonide(80mg) and 2cc ropivacaine0.2% with 16 ml of normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Shoulder joint movement limitation,
Pain for more than 3 years,
Promary adhesive capsulitis
|
|
| ExclusionCriteria |
| Details |
Hypersensitive to local anesthetic,
Glenohumeral pathology,
Malignacy,local site infection |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare analgesia in both groups |
To compare analgesia in both groups immediately after the procedure and after one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare range of motion of shoulder joint and analgesia |
To compare range of motion and analgesia after one week |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
11/03/2024 |
| 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="0"
Months="6"
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
|
This is the randomized interventional study to compare hydrodissection over steroids alone in 36 patients having shoulder joinr pain and restriction of joint movement at gmers medical college and hospital in Junagadh |