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CTRI Number  CTRI/2021/03/032450 [Registered on: 31/03/2021] Trial Registered Prospectively
Last Modified On: 27/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to asses the effectiveness of platelet rich plasma injection by intra-articular or rotator interval methods for management of periarthritis shoulder 
Scientific Title of Study   A Randomised controlled trial to asses the efficacy of USG-guided platelet rich plasma injection by intra-articular vs rotator interval methods for management of periarthritis shoulder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shubham Rahul Rai 
Designation  PG Resident Anaesthesia 
Affiliation  Lady hardinge Medical College 
Address  Department of Anaesthesiology,Lady Hardinge Medical College Central DELHI 110001 India

Central
DELHI
110001
India 
Phone  9818270302  
Fax    
Email  raishubhamrahul@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nitin Hayaran 
Designation  Professor 
Affiliation  Lady hardinge Medical College 
Address  Department of Anaesthesiology,Lady Hardinge Medical College Central DELHI 110001 India

Central
DELHI
110001
India 
Phone  9315175494  
Fax    
Email  nhayaran97@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shubham Rahul Rai 
Designation  PG Resident Anaesthesia 
Affiliation  Lady hardinge Medical College 
Address  Department of Anaesthesiology,Lady Hardinge Medical College Central DELHI 110001 India

Central
DELHI
110001
India 
Phone  9818270302  
Fax    
Email  raishubhamrahul@gmail.com  
 
Source of Monetary or Material Support  
Departmnent of Anaesthesiology, Lady hardinge medical college 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Shaheed bhagat singh marg New Delhi  
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 Shubham Rahul Rai  Lady Hardinge Medical College  Departments of Anaesthesiology and Obstetrics, Lady Hardinge Medical College,Shaheed Bhagat Singh Marg,New Delhi Central DELHI
Central
DELHI 		 9818270302

raishubhamrahul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M255||Pain in joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intra-articular method  Under Usg-guidance,3-4 ml of freshly prepared Platelet Rich Plasma will be injected intraarticularly. 
Intervention  Rotator Interval method  Under USG-guidance,3-4 ml of freshly prepared Platelet Rich Plasma will be injected by rotator interval method.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Adults(>18years) with chronic shoulder pain for > 6 months
2.Average Numerical Pain Rating Scale (NRS) > 4 
 
ExclusionCriteria 
Details  1.Any steroid injection within last 8 weeks.
2.Patients having coagulopathies, skin infection over shoulder area and allergy to local anesthetics.
3.Any shoulder surgery or arthroscopy of the affected shoulder within the past one year. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Shoulder Pain and Disability Index (SPADI) at 0,1st and 3rd month in both the groups.  0,1st and 3rd month 
 
Secondary Outcome  
Outcome  TimePoints 
1.Mean Numerical Pain Rating Scale(NRS) score at 0,1st and 3rd month follow-up in both the groups.
2.Proportion of patients with Post injection complications (infection or hematoma) at the site of injection in both the therapies. 		 0,1st and 3rd month 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   02/04/2021 
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="4"
Days="5" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   RESULTS WILL BE PUBLISHED IN A SCIENTIFIC JOURNAL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Shoulder pain is the 3rd leading cause of musculoskeletal pain after backpain and neck pain. Peri arthritis (PA), adhesive capsulitis, Rotator Cuff Tendinopathy (RCT), Acromioclavicular joint arthritis, Glenohumeral Osteoarthritis, inflammatory arthritis are some of the common causes of shoulder pain. Periarthritis shoulder/Frozen shoulder is a common condition resulting in insidious onset pain and global restriction of motion at the shoulder joint. Peak incidence between 46 and 64 years of age, with females more often affected.There is inflammation, thickening and contracture of the joint capsule as well as soft tissue fibrosis and inflammation of the rotator interval, capsule and ligaments. Painful stiffness of the shoulder can adversely affect activities of daily living and consequently impair quality of life.The typical natural history is of gradual resolution of symptoms over 1 to 3 year period and between 20% to 50% of patients may go on to develop long-lasting symptoms. A plethora of treatment options have been recommended which include benign neglect, oral corticosteroids, intra articular injection of corticosteroids, hyalouronic acid and platelet rich plasma(PRP), physical therapy exercises, deep heat modalities, manipulation under anaesthesia, hydro dilation, arthroscopic release. PRP has emerged as a new technology which is believed to stimulate revascularisation of soft tissue and increase the concentration of growth factors to improve and accelerate tendon healing. 
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