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OpenTrials
Completed

NCT Number: NCT05304884

Ozone Injection for Shoulder Impengement Syndrome

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).

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Key information

Study type

Interventional

Phase

Phase 4

Primary location

KTU Medical Faculty

Merkez, Trabzon, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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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.

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Treatment and study plan

combined oxygen-ozone and corticosteroid

Combination Product

Subacromial injection using Ultrasound

Primary outcomes

  1. The visual analog scale (VAS)

    Time frame: 3 months

Secondary outcomes

  1. Constant Murley Score (CMS)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Erzurum Regional Training & Research Hospital

Other Gov

Collaborators

  • Karadeniz Technical University

Registry information

Official study title

Clinical and Functional Outcomes of a Single Dose Ozone, Three Doses of Ozone and Corticosteroid Injection in Patients With Shoulder Impingement Syndrome

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 31, 2022
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.