drugset / Trial / NCT04062838

Prolotherapy for the Treatment of Partial Rotator Cuff Tears

NCT04062838

Phase 4 Withdrawn Hadassah Medical Organization
NaSingle-groupOpen-labelTreatment

Summary

This is a Prospective Pilot Single Arm study on prolotherapy for the treatment of patients with pain due to Partial Rotator Cuff (RC) Tears of the Shoulder. The aim of this trial is to study the effects of injected glucose on injured or degenerative RC tears of the shoulder. Glucose is not recognized by the FDA for this purpose but is used in 2 main concentrations: 50% solution to treat hypoglycemia and 5% solution for fluid replacement. In the prolotherapy group, 20% dextrose will be injected into 4 locations of the affected shoulder. In the active control group, patients will receive a single injection of methylprednisolone into the subacromial bursa and 3 saline injections overlying the tendons.

Timeline

Start
2020-08-01
Primary completion
2021-12-01
Completion
2022-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dextrose Unknown 20 % Other

Indications