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CTRI Number  CTRI/2024/04/066159 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 22/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the functional outcomes in shoulder impingement syndrome treated with arthroscopic subacromial decompression and platelet rich plasma (PRP) augmentation 
Scientific Title of Study   Evaluation of functional outcomes in shoulder impingement syndrome treated with arthroscopic subacromial decompression and platelet rich plasma (PRP) augmentation 
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 Raj Singh 
Designation  Professor and Head of Unit 
Affiliation  Pt.B.D.Sharma PGIMS Rohtak, Haryana 
Address  Department of Orthopaedics Pt.B.D.Sharma PGIMS Rohtak, Haryana

Rohtak
HARYANA
124001
India 
Phone  9416216950  
Fax    
Email  rajpotalia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vikrant Khatkar 
Designation  Junior Resident 
Affiliation  Pt.B.D.Sharma PGIMS Rohtak, Haryana 
Address  Department of Orthopaedics Pt.B.D.Sharma PGIMS Rohtak, Haryana

Rohtak
HARYANA
124001
India 
Phone  7015596834  
Fax    
Email  vikrant.khatkar.vk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vikrant Khatkar 
Designation  Junior Resident 
Affiliation  Pt.B.D.Sharma PGIMS Rohtak, Haryana 
Address  Department of Orthopaedics Pt.B.D.Sharma PGIMS Rohtak, Haryana

Rohtak
HARYANA
124001
India 
Phone  7015596834  
Fax    
Email  vikrant.khatkar.vk@gmail.com  
 
Source of Monetary or Material Support  
GOVERNMENT MEDICAL COLLEGE PGIMS Rohtak,HARYANA-124001 
 
Primary Sponsor  
Name  Pt BD Sharma PGIMS Rohtak 
Address  Department of Orthopaedics Pt.B.D.Sharma PGIMS Rohtak, Haryana-124001, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikrant Khatkar  Pt. B.D. Sharma, PGIMS Rohtak, Haryana  Research lab, Department of Orthopaedics, Pt.B.D. Sharma, PGIMS Rohtak, HARYANA
Rohtak
HARYANA 
7015596834

vikrant.khatkar.vk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M249||Joint derangement, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Evaluation of functional outcomes in shoulder impingement syndrome treated with arthroscopic subacromial decompression and platelet rich plasma (PRP) augmentation  Evaluation of functional outcomes in shoulder impingement syndrome treated with arthroscopic subacromial decompression and platelet rich plasma (PRP) augmentation would be done and clinical outcome will be done at 3weeks,3 months and 6 months 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  The inclusion criteria will be skeletally mature patients with shoulder pain lasting for
atleast 3 months with clinical diagnosis of shoulder impingement syndrome confirmed
with MRI scan. 
 
ExclusionCriteria 
Details  1. Radicular pain.
2. Presence of pathologies such as frozen shoulder, calcific tendinitis, biceps
subluxation, and a superior labrum anterior posterior lesion.
3. Previous shoulder surgery within last 6 months.
4. Connective tissue disorders such as rheumatoid arthritis, polymyalgia
rheumatica, or fibromyalgia.
5. Full thickness rotator cuff tear on MRI.
6. Ligamentous laxity (positive sulcus test) or shoulder dislocation (positive
apprehension test).
7. Prior corticosteroid injection within 3 months of the study.
8. Haemotological and bleeding diathesis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome
will be assessed during follow up period as per VAS Score, Constant Score, UCLA Score. 
Outcome
will be assessed during follow up period as per VAS Score, Constant Score, UCLA Score at 3 week, 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Any kind of skin reaction, pain and
complication will be noted during follow up period. 
Any kind of skin reaction, pain and
complication will be noted during follow up period of 3 week, 3 months and 6 months 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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 3 
Date of First Enrollment (India)   08/05/2024 
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="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  
Shoulder impingement results from an “inflammation and degeneration of the
anatomical structures in the region of the subacromial space”.

 The subacromial space is defined by the humeral head inferiorly, the anterior edge and under surface of the
anterior third of the acromion, coracoacromial ligament, and the acromioclavicular
joint superiorly. The height of space between acromion and humeral head ranges
from 1.0 to 1.5 cm as seen on radiographs (anteroposterior view).

SIS is believed to originate from extrinsic causes, intrinsic causes, or a combination of
both. Extrinsic causes, which result in compression of the rotator cuff tendons and
surrounding tissues, include anatomical variants of the acromion, a thickened
coracoacromial ligament, subacromial bursitis, or postural abnormalities.
 
Intrinsic causes are associated with degeneration of the rotator cuff tendons and include agerelated
degeneration that may vary in severity according to genetic predisposition, a
deficient vascular supply, a history of intensive work or tobacco. The diagnosis of SIS
is usually based on the patient’s history and on clinical exam such as the impingement
tests.
Painful shoulders pose a substantial socioeconomic burden, accounting for 2.4% of all
primary care consultations in the UK and 4.5 million visits to physicians annually in
the USA. Subacromial pain accounts for up to 70% of all shoulder-pain problems and
can impair the ability to work or do household tasks. The incidence of shoulder
impingement syndrome (SIS) increases as the population ages.

There are 2 types of treatment for SIS: nonsurgical and surgical. The nonsurgical
treatment options that are recommended usually include exercise therapy, subacromial
corticosteroid injection, rest, nonsteroidal anti-inflammatory drugs (NSAIDs),
physical modalities (eg, therapeutic ultrasound, electrotherapy, manual therapy), and
taping.

Surgical treatment involves decompressing the subacromial space by removing the
bone spur and any involved soft tissue arthroscopically, a procedure known as
arthroscopic subacromial decompression. The indications for surgery are persistent
and severe subacromial shoulder pain combined with functional restrictions that are
resistant to conservative measures.

The use of platelet-rich plasma (PRP) as a biological solution for injuries to tendons
of the rotator cuff has achieved popularity over the past several years. PRP is blood
plasma with a high platelet concentration that, once activated, releases various growth
factors involved in the tissue repair process. Early clinical evidence suggests that
PRP improves pain and function outcomes in some tendinopathies compared to
control injection and baseline status. This could be explained by the analgesic effect
of the PRP via the Protease-activated receptors 4 (PAR4) peptides. There is some
evidence demonstrating a positive effect of PRP in tendinopathies and osteoarthritis
of the knee; however, the evidence in rotator cuff tendinopathy is limited.

In spite of increased PRP use in clinical settings, we found only 3 randomized
controlled trials that evaluated the effectiveness of PRP injection in treating rotator
cuff tendinopathy nonsurgically.

In view of advantages of autologous PRP in SIS and reduction of subacromial
impingement by arthroscopic subacromial decompression we plan to study the
evaluation of functional outcome of arthroscopic subacromial decompression and
PRP augmentation in shoulder impingement syndrome.
 
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