Which therapy either prolotherapy or platelet rich plasma is better in rotator cuff disease

Not yet recruiting

Conditions: Disorders of synovium and tendon,

Registration Number: CTRI/2020/03/023748

Lead Sponsor: LADY HARDINGE MEDICAL COLLEGE

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 personâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Adults(>18years) with chronic shoulder pain for >6 months Average Numerical Pain Rating Scale (NRS) > 4.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Lady Hardinge Medical College And Associated Hospitals
🇮🇳
Central, DELHI, India
Lady Hardinge Medical College And Associated Hospitals
🇮🇳Central, DELHI, India
SANJAY PRAKASH
Principal investigator
9899266028
sanjayprakash20@gmail.com