drugset / Trial / NCT05131269

Prolotherapy Intervention in Patient With Frozen Shoulder

NCT05131269

Phase 4 Completed 32 enrolled Bumi Herman
RandomizedParallel-groupOpen-labelTreatment

Summary

Introduction : Prolotherapy is regenerative tissue therapy that is considered to be efficacious in reducing symptoms and morbidity of frozen shoulder, but only a few studies demonstrate the effect of prolotherapy at the biomolecular level, particularly the level of Matrix Metalloproteinase- I (MMP-1), Tissue Inhibitor Matrix Metalloproteinase (TIMP-1), as the biomarkers of cartilage repair. Objective: To determine the effect of prolotherapy on MMP-1, TIMP-1, and functional outcomes in frozen shoulder patients Method: a double-blind randomized controlled trial study involving participants who had been diagnosed with Frozen Shoulder. History taking, functional outcome assessment, MMP-1, and TIMP-1 were measured. The prolotherapy via intraarticular and extraarticular was performed four times, followed by the evaluation of functional outcome, MMP-1, and TIMP-1 at week 12 Alternative Hypothesis : Prolotherapy will increase the MMP-1, TIMP-1 levels, and improve functional outcome among Frozen Shoulder patients

Timeline

Start
2021-12-01
Primary completion
2022-05-31
Completion
2022-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dextrose Unknown 7.5 ml Other
Subject Dextrose Unknown 15 % Other

Indications