| CTRI Number |
CTRI/2025/05/087783 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Platelet rich plasma] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Platelet-rich Plasma and Steroid Injections for Frozen Shoulder Treatment |
|
Scientific Title of Study
|
A study to compare efficacy of intra-articular platelet rich plasma versus corticosteroid injection in treatment of adhesive capsulitis of 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 |
Dr Poulami Ghosh |
| Designation |
Junior resident |
| Affiliation |
R G Kar Medical College and Hospital |
| Address |
Dept. of Physical Medicine and Rehabilitation, R G Kar Medical College and Hospital
1, Khudiram Bose Sarani
Kolkata 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
|
| Fax |
|
| Email |
poulamiriaghosh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar Mandal |
| Designation |
Professor and Head of the Department |
| Affiliation |
R G Kar Medical College and Hospital |
| Address |
Dept. of Physical Medicine and Rehabilitation, R G Kar Medical College and Hospital
1, Khudiram Bose Sarani
Kolkata 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
9433915696 |
| Fax |
|
| Email |
rehabyouall@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Kumar Mandal |
| Designation |
Professor and Head of the Department |
| Affiliation |
R G Kar Medical College and Hospital |
| Address |
Dept. of Physical Medicine and Rehabilitation, R G Kar Medical College and Hospital
1, Khudiram Bose Sarani
Kolkata 700004
WEST BENGAL
700004
India |
| Phone |
9433915696 |
| Fax |
|
| Email |
rehabyouall@gmail.com |
|
|
Source of Monetary or Material Support
|
| R G Kar Medical College and Hospital, 1 Khudiram Bose Sarani, Kolkata, West Bengal, India, 700004 |
|
|
Primary Sponsor
|
| Name |
R G Kar Medical College and Hospital |
| Address |
1, Khudiram Bose Sarani, Kolkata 700004 |
| 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 Poulami Ghosh |
R. G. Kar Medical College and Hospital |
Dept. of Physical Medicine and Rehabilitation, Room No 109, Ground Floor, OPD building,
1, Khudiram Bose Sarani
Kolkata 700004
Kolkata
WEST BENGAL |
9874123543
poulamiriaghosh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, R. G. Kar Medical College |
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 |
| Comparator Agent |
Costicosteroid |
2ml of Methylprednisolone (40mg/ml) and 2ml of Lignocaine (2%)
Single dose at Day 0. |
| Intervention |
Platelet rich plasma |
Platelet rich plasma will be prepared by collecting 20 ml of sample of venous blood from the patient’s cubital vein under sterile aseptic precautions and it will be divided equally into 4 citrated vacutainers. Then the sample to be placed in a centrifuge and spun at 1500 rpm for 10 minutes. Using a needle, the buffy coat supernatant layer to be removed leaving behind the red and white cell components of the blood. The collected sample to be divided equally into two more vacutainers and spun at 3500rpm for another 10 minutes and the buffy coat to be aspirated and 3ml of it will be injected. Single dose at Day 0.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically stage 2 Adhesive capsulitis with duration of symptoms more than 3 months, but less than 9 months.
1. Patients with a normal radiograph finding of the affected shoulder.
2. Moderate to severe pain (visual analogue scale score more than 50)
3. Limitations of both active and passive movements of the glenohumeral joint of 25 percent or more in 2 or more directions (abduction, flexion, external rotation, internal rotation) as compared to contra lateral shoulder.
4. If bilateral shoulder is involved and qualify inclusion, only the dominant arm was considered for intervention.
|
|
| ExclusionCriteria |
| Details |
1. Patients with secondary adhesive capsulitis (inflammatory joint disease, structural or functional limitations in the shoulder joint from any other pre-existing musculoskeletal pathology or neurologic disorder).
2. Anaemia (haemoglobin less than 9)
3. Uncontrolled diabetes mellitus.
4. Poor cognitive status.
5. People who are unable to follow exercise program.
6. Patient who had previously undergone any intra articular injection or invasive procedure or surgery in the shoulder joint.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of pain in VAS Scale |
Data will be collected at Day 0, 3rd Week, 6th Week and 12th Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Limitations in activity of daily living (ADL) in shoulder pain and disability index (SPADI) score.
2. Range of motion of shoulder. |
Data will be collected at Day 0, 3rd Week, 6th Week and 12th Week |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/06/2025 |
| 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="2"
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
|
Frozen shoulder or adhesive capsulitis remains one of the most
prevalent causes of shoulder disability in the population. Both intra-articular
corticosteroid and platelet rich plasma injections has been effective treatments
for decreasing pain and improving function. Present study to establish the longterm effectiveness of platelet rich plasma versus corticosteroid injection will be
helpful and aid in deciding the more efficacious treatment option. |