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CTRI Number  CTRI/2020/03/023748 [Registered on: 04/03/2020] Trial Registered Prospectively
Last Modified On: 29/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Which therapy either prolotherapy or platelet rich plasma is better in rotator cuff disease 
Scientific Title of Study   A randomised controlled trial to assess the efficacy of prolotherapy vs platelet rich plasma therapy in patients with rotator cuff tendinopathy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SANJAY PRAKASH 
Designation  PG 1ST YEAR 
Affiliation  LADY HARDINGE MEDICAL COLLEGE 
Address  LADY HARDINGE MEDICAL COLLEGE AND ASSOCIATED HOSPITALS SHAHEED BHAGAT SINGH MARG CONNAUGHT PLACE New Delhi

Central
DELHI
110001
India 
Phone  9899266028  
Fax    
Email  sanjayprakash20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  NITIN HAYARAN 
Designation  PROFESSOR 
Affiliation  LADY HARDINGE MEDICAL COLLEGE 
Address  LADY HARDINGE MEDICAL COLLEGE AND ASSOCIATED HOSPITALS SHAHEED BHAGAT SINGH MARG CONNAUGHT PLACE New Delhi

Central
DELHI
110001
India 
Phone  9873903603  
Fax    
Email  nhayaran97@gmail.com  
 
Details of Contact Person
Public Query
 
Name  NITIN HAYARAN 
Designation  PROFESSOR 
Affiliation  LADY HARDINGE MEDICAL COLLEGE 
Address  LADY HARDINGE MEDICAL COLLEGE AND ASSOCIATED HOSPITALS SHAHEED BHAGAT SINGH MARG CONNAUGHT PLACE New Delhi

Central
DELHI
110001
India 
Phone  9873903603  
Fax    
Email  nhayaran97@gmail.com  
 
Source of Monetary or Material Support  
LADY HARDINGE MEDICAL COLLEGE AND ASSOCIATED HOSPITALS 
 
Primary Sponsor  
Name  LADY HARDINGE MEDICAL COLLEGE 
Address  LADY HARDINGE MEDICAL COLLEGE AND ASSOCIATED HOSPITALS SHAHEED BHAGAT SINGH MARG CONNAUGHT PLACE 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 
SANJAY PRAKASH  Lady Hardinge Medical College And Associated Hospitals   DEPARTMENT OF ANAESTHESIA SHAHEED BHAGAT SINGH MARG CONNAUGHT PLACE-110001
Central
DELHI 
9899266028

sanjayprakash20@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: M65-M67||Disorders of synovium and tendon,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Platelet Rich Plasma Therapy  5ml of freshly prepared PRP will be injected in the vicinity of injured tendon under high frequency (13-6Hz) ultrasound guidance 
Comparator Agent  Prolotherapy  5ml of 25% dextrose will be injected in the vicinity of tendinopathy/tear under high frequency(13-6Hz) ultrasound guidance. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults(>18years) with chronic shoulder pain for >6 months
Average Numerical Pain Rating Scale (NRS) > 4
 
 
ExclusionCriteria 
Details  Any corticosteroid injection within last 8 weeks
Complete Rotator cuff tear
Patients having chronic pain due to other diseases like malignancy, cervical radicular pain, stroke, uncontrolled diabetes and having coagulopathies, skin infection over shoulder area and allergy to local anesthetics
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   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in Mean Numerical Pain Rating Scale(NRS)score in both the groups group P(Prolotherapy) and group R (PRP therapy) at 1 month 3 month and 6 month follow up  1 month
3 month
6 month 
 
Secondary Outcome  
Outcome  TimePoints 
Shoulder Pain and Disability Index (SPADI) at 1 month 3 month and 6 month
Proportion of patients with Post injection complications (infection or hematoma) at the site of injection in both the therapies 
1 month
3 month
6 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   08/03/2020 
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   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)?  

Brief Summary  

Shoulder pain is the 3rdleading cause of musculoskeletal pain after backpain and neck pain.

Reported prevalence is around 6.9% to34%. Shoulder pain interferes with a person’s daily activities, social events and overall decreases quality of life.

Causes of shoulder pain comprises of causes like Rotator Cuff Tendinopathy (RCT), Osteoarthritis, Adhesive Capsulitis, Acromioclavicular joint arthritis, Glenohumeral Osteoarthritis.

Rotator cuff tendinopathy is the major cause of shoulder pain and disability and occurs in about one in five symptomatic shoulders1. Lesions range from acute tendinitis to full thickness tears involving the supraspinatus, infraspinatus and subscapularis tendons. In younger individuals, pathologies occur from repetitive overuse injuries or acute traumatic events whereas in older population usually present without a history of predisposing trauma.

Conservative treatment includes rest, activity modification and anti-inflammatory drugs. Injection therapies are the next line of management followed by surgical management. Corticosteroid, Prolotherapy and Platelet Rich Plasma (PRP)therapy are the most commonly injected drugs.

Among these drugs corticosteroid is the most widely injected and studied therapy. The response to steroid injection is quite variableand pain reduction is of short term(3-6weeks) and complications like muscle weakness, tendon rupture, joint infection, nerve damage, osteoporosis and osteonecrosis are seen2.

Prolotherapy involves the injection of irritant agents into an area of painful tendinosis, which initiates an inflammatory cascade at the site of injection, which further causes fibroblast proliferation and subsequentcollagen synthesis3.The inflammatory response improves pain by reducing inappropriate neovascularisation and neural ingrowth at the sites of chronic tendinopathy.

PRP injections locally deliver high concentrations of biological factors essential to the healing process to augment musculoskeletal tissue repair4

Both Prolotherapy and PRP therapy are found to be safe if proper antiseptic precautions are taken and forceful intratendinous injections are avoided. There are no comparative studies on the efficacy of Prolotherapy and PRP therapy for rotator cuff tendinopathy.

There is limited literature on comparison of analgesic efficacy between the Prolotherapy and PRP therapy in patients with Rotator Cuff Tendinopathy. No studies have been done on Indian population. Hence, the present study is designed to compare the analgesic efficacy of prolotherapy and PRP therapy in patients with rotator cuff tendinopathy.


 
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