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
|
|
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
|
|
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. |