| CTRI Number |
CTRI/2025/12/099851 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing steroid injection alone versus steroid with joint-lubricating injection for pain relief and better shoulder function in frozen shoulder |
|
Scientific Title of Study
|
Effectiveness of ultrasound guided intra-articular injection of Methylprednisolone acetate with Hyaluronic acid compared with injection Methylprednisolone acetate for pain relief and functional improvement in patients with Adhesive capsulitis: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GOKUL MURALIDHARAN |
| Designation |
PG Trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
PMR Department
RIMS, Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9048681833 |
| Fax |
|
| Email |
gokuldocul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. N Bimol |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
PMR Department
RIMS, Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005291542 |
| Fax |
|
| Email |
bimoldr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
GOKUL MURALIDHARAN |
| Designation |
PG Trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
PMR Department
RIMS, Imphal, Manipur
MANIPUR
795004
India |
| Phone |
9048681833 |
| Fax |
|
| Email |
gokuldocul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences, Imphal |
|
|
Primary Sponsor
|
| Name |
Regional Institute of Medical Sciences |
| Address |
Imphal, Manipur
795004 |
| 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 Gokul Muralidharan |
Regional Institute of Medical Sciences, Imphal |
Department of PMR,RIMS, Lamphelpat, Imphal, Manipur, 795004
Imphal West
MANIPUR |
9048681833
gokuldocul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARDS RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High molecular weight hyaluronic acid and Methylprednisolone acetate |
Ultrasound guided intra-articular injection of Methylprednisolone acetate 80mg with high molecular weight Hyaluronic acid 6ml, single dose. |
| Comparator Agent |
Methylprednisolone acetate |
Ultrasound guided intra-articular injection of methylprednisolone acetate 80 mg, single dose. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of adhesive capsulitis
Stage 1 to 3 adhesive capsulitis
Patients who are willing to comply with the study and follow up assessments
|
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled diabetes
History of shoulder trauma/surgery
History of injection in the shoulder joint in past three months
Non-steroidal anti-inflammatory drugs intake in last seven days
Autoimmune disorders
Impaired cognition
Any febrile or infectious disease (systemic & local)
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain relief and functional improvement in patients with adhesive capsulitis |
Baseline, 1 week, 4 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
05/01/2026 |
| 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="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
|
The
various treatment options available include NSAIDS, oral corticosteroids,
intra-articular injection of corticosteroids, intra-articular injection of
hyaluronic acid, physical therapy exercises, deep heat modalities,
manipulation under anaesthesia, hydro dilatation, arthroscopic release but the
best treatment is still subjected to debate. Due to a lack of evidence in
combined use of hyaluronic acid and corticosteroids in the treatment of
adhesive capsulitis there is a need to examine the role of this combined
treatment since both intraarticular HA and corticosteroids separately have
shown benefits in treatment of adhesive capsulitis
|