| CTRI Number |
CTRI/2024/04/065537 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Stem Cell Therapy
Other (Specify) [Suprascapular Nerve Block ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of ultrasound guided Suprascapular Nerve Block versus Intra- Articular Platelet Rich Plasma for Periarthritis Shoulder pain |
|
Scientific Title of Study
|
Comparison of Efficacy of Ultrasound guided Suprascapular Nerve Block Versus Intra-Articular Platelet Rich Plasma in Periarthritis Shoulder Pain: A Randomized Controlled Trial |
| 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 Vinay Kanaujia |
| Designation |
Assistant Professor |
| Affiliation |
Uttar Pradesh University Of Medical Sciences |
| Address |
Room no 16 Deapartment Of PMR Old OPD Building Ground Floor UPUMS Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8800121450 |
| Fax |
|
| Email |
vinay.kanaujia87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Kanaujia |
| Designation |
Assistant Professor |
| Affiliation |
Uttar Pradesh University Of Medical Sciences |
| Address |
Room no 16 Deapartment Of PMR Old OPD Building Ground Floor UPUMS Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8800121450 |
| Fax |
|
| Email |
vinay.kanaujia87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinay Kanaujia |
| Designation |
Assistant Professor |
| Affiliation |
Uttar Pradesh University Of Medical Sciences |
| Address |
Room no 16 Deapartment Of PMR Old OPD Building Ground Floor UPUMS Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8800121450 |
| Fax |
|
| Email |
vinay.kanaujia87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh , INDIA -206130 |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical Sciences |
| Address |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh, INDIA-206130. |
| 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 Vinay Kanaujia |
Uttar Pradesh University Of Medical sciences |
Room No 16, Department Of Physical Medicine And Rehabilitation,Ground Floor, Old OPD Building.
Etawah
UTTAR PRADESH |
8800121450
vinay.kanaujia87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Uttar Pradesh University Of Medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, (2) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound Guided Intra- Articular Platelet Rich Plasma Injection in Shoulder joint |
In Group A 30 ml blood will be collected from the participants and after centrifugation 3 ml PRP will be collected. Participants will receive USG guided freshly prepared PRP intra-articular injection in affected shoulder under aseptic preparations using 21 Gauge needle and 5 ml syringe. |
| Intervention |
USG guided Suprascapular Nerve Block |
Suprascapular nerve block on affected side will be infiltrated with 10 ml of 0.5% Bupivacaine with all aseptic precautions using 21 gauge needle and 10 ml syringe.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years, clinically diagnosed with periarthritis shoulder
Duration of symptoms more than 4 weeks
Normal anteroposterior radiographs of the glenohumeral joint
|
|
| ExclusionCriteria |
| Details |
History of shoulder trauma, dislocation or fractures in the shoulder area, History of injection in the involved shoulder during the preceding 6 months, Bleeding disorders, Uncontrolled diabetes mellitus, Active infection at site of injection, History of allergy to local anaesthetics, Use of anticoagulant drugs in past 7 days and Affected shoulder surgery in past 1 year.
9. Patients who are pregnant or breastfeeding.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale |
At the time of intervention, then at 2 weeks , 6 weeks and 12 weeks post intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Shoulder Pain and Disability Index
Range Of Motion |
At the time of intervention, then at 2 weeks , 6 weeks and 12 weeks post intervention. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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 - NO
|
Brief Summary
Modification(s)
|
American academy of orthopaedic surgeons defines periarthritis shoulder (PA shoulder) as a condition of uncertain aetiology characterized by significant restriction of both active and passive range of motion that occurs in the absence of a known intrinsic shoulder disorder.[1] This condition also commonly known as “Adhesive capsulitis†and “frozen shoulder†has a prevalence of 2-5% in general population. It is 2 to 4 times more common in women than man and affects middle age and elderly people.[2] It is characterized by painful, restricted shoulder range of motion (ROM) in patients with normal radiographs. Treatment for periarthritis shoulder includes non-steroidal anti- inflammatory drugs, electrotherapy, exercise regimens, intra-articular steroid injections, suprascapular nerve blocks, manipulation under anesthesia, hydrodilatation, arthroscopic capsular release and recent modalities like platelet rich plasma.[2] Suprascapular nerve block is known to be a safe and effective treatment for chronic shoulder pain in conditions like periarthritis shoulder irreparable rotator cuff tear, calcific tendinitis, stroke sequalae.[3] Platelet rich plasma (PRP) is component of plasma containing higher concentration of platelets and growth factors. It is obtained after centrifugation of patient’s own blood. Being rich in growth factors it is believed to increase vascularity and improve healing process. Considering these properties, intra-articular PRP injections might prove beneficial for PA shoulder patient. Therefore, its efficacy needs to be examined and compared with other available treatments.[4] Despite availability of above treatment option for years, evidence regarding their efficacy is unclear. With origin of newer treatment options like platelet rich plasma, it has become important to study effect of conventional methods and their comparison with recent advance methods. Through this study, we are comparing efficacy of intra-articular platelet rich plasma injection with suprascapular nerve block in patients with periarthritis shoulder. |