Comparing the clinical efficacy of multiple vs. single dose ozone (O2-O3) injections and corticosteroid injection in subacromial impingement syndrome: A prospective,randomized controlled trial with One-Year Follow-Up

Abstract

Background

Ozone (O2-O3) therapy, is a novel and increasingly utilized intervention in musculoskeletal medicine. This therapeutic approach has gained attention for its potential in managing conditions such as chronic pain, arthritis, and soft tissue injuries, offering a minimally invasive alternative to conventional treatments.

Objective

This study aims to explore the effectiveness of multiple-dose ozone injections in subacromial impingement syndrome (SAIS) and to compare it with single-dose ozone and corticosteroids regarding patient-related clinical outcomes.

Methods

This single-center prospective randomized controlled clinical trial comprised 108 SAIS patients divided into three groups: Group 1, multiple-dose ozone (50 mcg ozone/ week for five weeks); Group 2, single-dose ozone (50 mcg ozone) and Group 3, single-dose corticosteroid (40 mg triamcinolone). The pain, functionality, and quality of life of the patients were evaluated via the Visual Analogue Scale (VAS), Constant-Murley score (CMS), University of California Los Angeles Shoulder Scale (UCLA), and 36-Item Survey Short-Form (SF-36) in three, six and twelve months. ANOVA/Friedman's test was applied to evaluate the statistical differences between the groups for each outcome measure at each time point.

Results

The mean age of the study population was 53.3 ± 3.1 years, and 52.8% of them were female. In the first week, the steroid group scored less than the other two groups (p < 0.001) in VAS. At 3, 6, and 12 months, CMS was significantly higher in the multiple ozone group compared to the other two groups (p < 0.001 for all). UCLA scores increased in all groups, with the greatest improvement observed in the multiple ozone group. After 12 months, all groups differed significantly in SF-36 scores (65.0 [11.0] in the multiple-ozone group, 43.5 [4.8] in the ozone group, and 40.0 [11.0] in the steroid group, p < 0.001).

Conclusions

Multiple ozone (O2-O3) injections had better patient-related outcomes regarding pain, functioning, and quality of life in patients with SAIS in 3-m, 6-m, and one-year follow-up periods.