Ozone Injection for Shoulder Impengement Syndrome

Phase 4

Completed

• Conditions: Research on the Effectiveness of a Corticosteroid, Single Dose and Three Doses of Ozone Injection in Shoulder Impingement Syndrome
• Interventions: Combination Product: combined oxygen-ozone and corticosteroid

• Registration Number: NCT05304884
• Lead Sponsor: Erzurum Regional Training & Research Hospital

Brief Summary

Ozone injection has lately been utilized as a safe alternative to corticosteroids in the management of musculoskeletal diseases with fewer side effects. This study aimed to compare the effectiveness of a corticosteroid, single dose and three doses of ozone injection in shoulder impingement syndrome (SIS).

Detailed Description

A hundred and eight SIS patients were divided into three groups and underwent subacromial injections in this prospective study. Group 1 received a single dose (n:36), group 2 (n:36) received three doses of ozone injection (n :36). Group 3 (n:36) was treated with a corticosteroid injection. Patients were evaluated using the visual analog scale (VAS) and Constant Murley Score (CMS), pre-injection and at 4 weeks and 12 weeks.

Study Timeline

• Study Start: 2021-06-30
• Primary Completion: 2022-02-22
• Status Verified: 2022-03
• Study Completion: 2022-03-22
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Last Update Submitted: 2022-03-22
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 108

Inclusion Criteria

patients older than 18 years with shoulder pain lasting for more than three months, pain severity more than 5/10 on Visual Analog Scale (VAS), and diagnosed with SIS according to clinical examination and magnetic resonance imaging (MRI), were enrolled in this randomized clinical study.

Exclusion Criteria

The exclusion criteria were as follows: existing pathological abnormalities such as full-thickness rotator cuff tears on MRI, any cause of shoulder pain other than SIS such as inflammatory joint diseases, shoulder osteoarthritis and adhesive capsulitis, restriction of shoulder range of motion, coagulation disorders or use of anticoagulants, previous history of shoulder trauma, surgery or fracture, history of any subacromial injection or physical therapy for the last year, contraindications for ozone injection such as known Glucose 6 phosphate dehydrogenase deficiency, pregnancy, uncontrolled hyperthyroidism, and leukemia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
corticosteroid	combined oxygen-ozone and corticosteroid	Group 3 (n:36) was treated with a corticosteroid injection
single dose ozone	combined oxygen-ozone and corticosteroid	Group 1 received a single dose ozone injection (n:36)
three doses of ozone	combined oxygen-ozone and corticosteroid	Group 2 (n:36) received three doses of ozone injection (n :36).

Primary Outcome Measures

Name	Time	Method
The visual analog scale (VAS)	3 months

Secondary Outcome Measures

Name	Time	Method
Constant Murley Score (CMS)	3 months

Trial Locations

Locations (1)

KTU Medical Faculty; 🇹🇷 Merkez, Trabzon, Turkey