Effects of Dextrose Prolotherapy in Rotator Cuff Disease

Rotator Cuff Disease Clinical Trial

Official title: Effects of Dextrose Prolotherapy in Rotator Cuff Disease: A Randomized Controlled Study

Status Recruiting

Clinical Trial Summary

The aim of this prospective, randomized, controlled, single-blind study is to determine the effects of dextrose prolotherapy on shoulder pain and functions in patients with chronic rotator cuff disease.

Clinical Trial Description

Rotator cuff disease is a major cause of shoulder pain and disability. Non-surgical treatments to reduce pain and improve function have included therapeutic exercises, NSAIDs, subacromial corticosteroid injections. However, some patients are resistant to these conservative treatments. In recent years, prolotherapy has increased in popularity for the treatment of musculosketal conditions. Regenerative injection methods can be applied in resistant chronic rotator cuff disease. In this prospective, randomized controlled, single blind, interventional study, a total of 60 patients with shoulder pain due to rotator cuff disease who meet eligibility criteria will be enrolled in the study. Eligible participants will be randomly assigned to one of the two groups using computer-generated random numbers. In the dextrose prolotherapy group, ultrasound-guided prolotherapy injections will be applied under aseptic conditions at 0, 3, and 6 weeks. In the salin injection group, salin injections will be applied under aseptic conditions at 0, 3, and 6 weeks. Home exercise program will be apply to both groups. Participants are going to evaluate before injection, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, with the Shoulder Pain and Disability Index (SPADI) change in pain and disability score, with The University of California and Los Angeles Rating Score (UCLA) change in pain and functional score and the change in the Ultrasound Shoulder Pathology Rating Scale (USPRS). ;

Related Conditions & MeSH terms

• Rotator Cuff Disease

• NCT number: NCT04805242
• Study type: Interventional
• Source: Istanbul University
• Contact: Selim Sezikli, MD
• Phone: +902124142000
• Email: selimsezikli@hotmail.com
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2021
• Completion date: November 12, 2021