| CTRI Number |
CTRI/2024/03/064768 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effects of intra-articular platelet rich
plasma and corticosteroid injection in frozen shoulder
|
|
Scientific Title of Study
|
Comparison of effects of intra-articular platelet rich
plasma and corticosteroid injection in Adhesive capsulitis
of shoulder joint: a double blinded randomized control
study. |
| 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 Sreeju R S |
| Designation |
Post Graduate |
| Affiliation |
SDM college of medical sciences and Hospital Dharwad– 580009. |
| Address |
Room number 4, Ground floor
Department of Orthopaedics
SDM College of MedicaL Sciences and Hospital, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9742487228 |
| Fax |
|
| Email |
drsreejurs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath S Daragad |
| Designation |
Professor |
| Affiliation |
SDM college of medical sciences and Hospital Dharwad– 580009. |
| Address |
Room number 4, Ground floor
Department of orthopaedics
SDM college of medical sciences and hospital, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9880372833 |
| Fax |
|
| Email |
daragad.manjunath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjunath S Daragad |
| Designation |
Professor |
| Affiliation |
SDM college of medical sciences and Hospital Dharwad– 580009. |
| Address |
Room number 4, Ground floor
Department of orthopaedics
SDM college of medical sciences and hospital, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9880372833 |
| Fax |
|
| Email |
daragad.manjunath@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of medical sciences and hospital, Dharwad-
580009 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Self funding] |
|
|
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 Manjunath S Daragad |
SDM Hospital |
Room number 4, Ground floor
Department of Orthopaedics
SDM college of medical sciences and hospital, Dharwad-
580009
Dharwad
KARNATAKA |
9880372833
daragad.manjunath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM INSTITUITIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intra-articular corticosteroid in adhesive capsulitis of shoulder joint |
2ml(1ml of methylprednisolone 40 mg and 1 ml of 2% lignocaine) will be injected under aseptic condition under the guidance of ultrasound machine. Patient will be asked to follow up after 2 weeks,6 weeks ,3months
and 6 months.Patient will be evaluated by using shoulder pain and disability index (SPADI) and VAS score. |
| Intervention |
Intra-articular platelet rich plasma in Adhesive capsulitis of shoulder joint |
2 ml of platelet rich plasma will be injected under aseptic condition under the guidance of ultrasound machine. Patient will be asked to follow up after 2 weeks,6 weeks ,3months
and 6 months.Patient will be evaluated by using shoulder pain and disability index (SPADI) and VAS score. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed as primary AC, with duration of
symptoms less than 6 months,
2. Normal radiograph of the affected shoulder,
3. Moderate to severe VAS Score and limitation of both
Active and passive movements of gleno-humeral joint in 2
or more directions (abduction, adduction, flexion, extension,
external rotation, internal rotation).
4.If bilateral involvement and qualify for inclusion, only
dominant arm is considered for intervention |
|
| ExclusionCriteria |
| Details |
1.secondary adhesive capsulitis, secondary to inflammatory joint disease,
structural ,functional limitations in the shoulder joint from any other pre-existing musculoskeletal pathology or
neurological disorder
2.Uncontrolled Diabetes Mellitus
3.Underwent any intra-articular injection/ invasive
procedure/surgery in the shoulder joints.
4.Who are unable to follow exercise program.
5.Any local skin pathology at injection site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of disability and improvement of Range of motion. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the outcome of intra-articular PRP vs CS injection in the treatment of adhesive capsulitis. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/03/2024 |
| Date of Study Completion (India) |
05/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsreejurs@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 05-03-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Patients between 18-70 years of either sex who comes to orthopaedic OPD, clinically diagnosed with adhesive capsulitis during my study period, who are fulfilling the inclusion criteria will be explained about study purpose, procedures, potential risks, and benefits. Informed consent will be taken. The first patient will be allotted in group A(methylprednisolone acetate) and the next patient will be allotted to group B (PRP). Same pattern will be continued for the study. This way randomization is done. Relevant blood investigations, x-ray / ultrasonography evaluation of the shoulder will be done to rule out other causes. Both patients and trained personal who is giving the injection will be unaware of the group in which the patient is allotted. Identical syringes (covered) are used to maintain blinding. Intra-articular injections of methylprednisolone acetate (40mg) or platelet rich plasma will given to the respective groups according to the randomization. Injection will be administered by a trained personal under ultrasound guidance. Patients are seated on a chair, in an upright position with their hands positioned on their thigh. A 23- gauge, 7cmlong needle will be inserted parallel to the ultrasound probe until tip of the needle is inside the gleno-humeral joint. Preparation of PRP: - Draw 20 ml of venous blood and collect it in the PRP tube Centrifuge the PRP tube at 4400 RPM for 12 minutes followed by 2200 RPM for 10 minutes. Aspirate the Platelet rich plasma, from the Buffy coat layer. All injections ,IA-PRP (2 ml) and IA- Methylprednisolone acetate 2ml ( 1ml of methyl prednisolone acetate + 1ml of 2% of lignocaine) to be given under aseptic condition. After giving injection, patients will be given Paracetamol + Tramadol for the initial pain relief. Patients will be advised for physiotherapy and follow up at 2 weeks, 6 weeks, 3 months and 6 months in orthopaedic OPD. Schedule regular follow-up assessments to monitor participants progress, including range of motion, pain levels by visual analogue scale (VAS) score, Shoulder Pain And Disability Index (SPADI) Collect quantitative data on outcomes, ensuring standardized measurement score are used consistently.
|