| CTRI Number |
CTRI/2024/11/076764 [Registered on: 13/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effectiveness of USG guided platelet rich plasma to corticosterioid in patients of shoulder impingement syndrome. |
|
Scientific Title of Study
|
Comparison of USG guided platelet rich plasma Injection to corticosteroid injection in treatment of
shoulder impingement |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit Krishna Dev |
| Designation |
Post Graduate Resident |
| Affiliation |
Guru Teg Bahadur hospital, University of medical sciences, new delhi |
| Address |
Room Number- 1024, Department of Radiodiagnosis, University College of Medical Sciences & Guru Teg Bahadur Hospital, Delhi- 110095
Room Number- 1024, Department of Radiodiagnosis, University College of Medical Sciences & Guru Teg Bahadur Hospital, Delhi- 110095
East
DELHI
11095
India |
| Phone |
7906311581 |
| Fax |
|
| Email |
rk88dev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anupama Tandon |
| Designation |
Professor (CAS) |
| Affiliation |
Guru Teg Bahadur hospital, University of medical sciences, new delhi |
| Address |
Room Number- 1007, Department of Radiodiagnosis, University College of Medical Sciences & Guru Teg Bahadur Hospital, Delhi- 110095
Room Number- 1007, Department of Radiodiagnosis, University College of Medical Sciences & Guru Teg Bahadur Hospital, Delhi- 110095
East
DELHI
110095
India |
| Phone |
8585977903 |
| Fax |
|
| Email |
anupamatandon@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohit Krishna Dev |
| Designation |
Post Graduate Resident |
| Affiliation |
Guru Teg Bahadur hospital, University of medical sciences, new delhi |
| Address |
Room Number- 1024, Department of Radiodiagnosis, University College of Medical Sciences & Guru Teg Bahadur Hospital, Delhi- 110095
Room Number- 1024, Department of Radiodiagnosis, University College of Medical Sciences & Guru Teg Bahadur Hospital, Delhi- 110095
East
DELHI
110095
India |
| Phone |
7906311581 |
| Fax |
|
| Email |
rk88dev@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Radiodiagnosis, University College of Medical Sciences & Guru Teg Bahadur Hospital, Delhi- 110095, India |
|
|
Primary Sponsor
|
| Name |
Guru Teg bahadur Hospital, University of Medical Sciences |
| Address |
GTB Hopital, UCMS, Dilshad Garden, New delhi. |
| 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 Rohit Krishna Dev |
Guru Teg Bahadur Hospital, University College of Medical Science |
Room Number- 1024, Department of Radiodiagnosis, Delhi- 110095
East
DELHI |
7906311581
rk88dev@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee- Human Research (IEC-HR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M754||Impingement syndrome of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
USG guided Platelet rich plasma injection |
For ultrasound guided platelet rich plasma injection, the patient will be placed in lateral lying position and the procedure will be performed via lateral approach. The platelet rich plasma will be injected at the site of pathology/subacromial space. Only single injection will be given and procedure will take around 5-10 minutes (excluding duration of PRP preparation). |
| Comparator Agent |
USG guided steroid injection. |
For ultrasound corticosteroid injection, the patient will be placed in lateral lying position and the procedure will be performed via lateral approach.
Corticosteroid preparation will be injected into the subacromial bursa only. Single injection will given to the patient and the procedure is expected to take 5-10 minutes
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients having clinically diagnosed/suspected shoulder pathologies with refractory/recurrent pain and functional deficit for more than 2 months not
resolving with conservative treatments i.e. NSAIDs and physiotherapy. |
|
| ExclusionCriteria |
| Details |
• Pregnant patients
• Patients having other causes of shoulder pain such as adhesive capsulitis, full thickness rotator
cuff tears, major trauma, recurrent dislocations, osteoarthritis, inflammatory joint disease,
cervical radiculopathy, thoracic outlet syndrome and bone tumors/ other malignancy at
shoulder joint.
• Patients already diagnosed with neuromuscular disease or muscle disease.
• Patients with underlying coagulopathies, thrombocytopenia or taking anti-coagulant
medications or having pace-maker.
• Patients with local site infection or localised dermatological condition.
• Patients who have recieved prior corticosteroid injection or have taken NSAIDs in last
week(relative contra-indication).
• Patients who have undergone arthroscopic or open surgery of the affected shoulder, back or
neck or have metallic implants in situ in the affected shoulder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change from baseline of severity of symptoms and functional status using QDASH questionnaire
in the two groups.
2. Change from baseline of pain using Visual Analogue Scale (VAS) in the two groups.
3. Change from baseline of range of movements using goniometer in the two groups.
4. Comparison of the improvement between the two groups. |
Evaluation will be done at baseline, 6 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of improvement of quality of life after the completion of the treatment in both
groups using WORC.
2. To document any change in USG appearances/findings in the two groups, if any. |
Evaluation will be done at baseline, 6 weeks & 12 weeks |
|
|
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)
|
02/12/2024 |
| 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="10"
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
|
Shoulder impingement syndrome is most common cause of chronic shoulder pain often causing limitation in range of movement at the shoulder joint. Shoulder’s extreme mobility makes these symptoms cause great stress to the patient leading to decreased quality of life. Rest, NSAIDs and physiotherapy have long been considered the standard therapies in the majority of cases. However, there are limited treatment options for the patients who are refractory to these conventional treatments and their daily life activities are hindered due to the chronicity of symptoms. Corticosteroid injections with their anti inflammatory effects have been used in such cases for short term relief but it has some inherent disadvantages such as no long term effects, infection, tendon ruptures, fat atrophy, etc. So there is need of newer agents that can provide long-term effects and fewer side effects. Platelet rich plasma is a new biological agent that has low side effects and can promote healing/regeneration. This study aims to evaluate the effects of platelet rich plasma administered under USG guidance and compare its efficacy in the treatment of such patients with shoulder pathologies who are refractory to conventional treatment against old guard recommendation of corticosteroids. |