| CTRI Number |
CTRI/2025/02/080140 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Platelet rich plasma on shoulder pain |
|
Scientific Title of Study
|
To evaluate the effect of platelet rich plasma on shoulder pain and disability index in patients of rotator cuff tear: an observational 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 |
Vanita Ahuja |
| Designation |
Professor |
| Affiliation |
Professor |
| Address |
Department of Anaesthesia and Intensive Care
521, B Block, level 5
Government Medical College and Hospital
Sector 32 Chandigarh
Department of Anaesthesia and Intensive Care
521, B Block, level 5
Government Medical College and Hospital
Sectore 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaanupam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vanita Ahuja |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesia and Intensive Care |
| Address |
Department of Anaesthesia and Intensive Care
521, B Block, level 5
Government Medical College and Hospital
Sectore 32 Chandigarh
521, B Block, level 5
Government Medical College and Hospital
Sectore 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaanupam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vanita Ahuja |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Anaesthesia and Intensive Care
521, B Block, level 5
Government Medical College and Hospital
Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaanupam@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care |
| Address |
Government Medical College and Hospital
Sektorer 32 Chandigarh |
| 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 Vanita Ahuja |
Government Medical College and Hospital |
B Block Level 5GMCH
Sector 32
Chandigarh
Chandigarh
CHANDIGARH |
9646121649
vanitaanupam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M668||Spontaneous rupture of other tendons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
PRP in patients with shoulder rotator cuff tear |
under ultrasound guidance platelet concentrate 5-8 ml will be injected in the area of partial tear of muscles of rotator cuff tear/tendinosis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Partial rotator cuff tear
Visual analogue scale score of more than 3 for more than 3 months
Patients who can understand and read Hindi and English
|
|
| ExclusionCriteria |
| Details |
1. History of previous surgery of shoulder joint
2. Complete tear of rotator cuff muscles with complete atrophy
3. Uncontrolled systemic disease
4. Known hypersensitivity to any of the local anaesthetics drug under study
5. History of any platelet or coagulation related disease
6. Red Flag signs : fracture, fever, malignancy, infection, unexplained weight loss, numbness/weakness of upper limb, night sweats
7. Patients with human immunodeficiency virus (HIV,) hepatitis C virus (HCV) and hepatitis B virus (HBsAg)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of platelet rich plasma (PRP) difference on shoulder pain and disability index (SPADI) |
2 weeks, 1 month, 2 month, 3 month and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. change in analgesic requirement
2. change in range of shoulder movement
3. patient satisfaction score and platelet count
4. any side effects |
1.Baseline, 1 month, 2 month, 3 months, 6 months
2.Baseline, 1 month, 2 month, 3 months, 6 months
3. 3 months , 6 months
4. Baseline, 1 month, 2 month, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/02/2025 |
| 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="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
|
N/A |