Ozone Injection for Shoulder Impengement Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Research on the Effectiveness of a Corticosteroid, Single Dose and Three Doses of Ozone Injection in Shoulder Impingement Syndrome

Intervention / Treatment
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* Combination Product: combined oxygen-ozone and corticosteroid


Participation Criteria
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Eligibility Criteria
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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. -

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: single dose ozone<br>Group 1 received a single dose ozone injection (n:36) | Combination Product: combined oxygen-ozone and corticosteroid<br>* Subacromial injection using Ultrasound<br>|
| Active Comparator: three doses of ozone<br>Group 2 (n:36) received three doses of ozone injection (n :36). | Combination Product: combined oxygen-ozone and corticosteroid<br>* Subacromial injection using Ultrasound<br>|
| Active Comparator: corticosteroid<br>Group 3 (n:36) was treated with a corticosteroid injection | Combination Product: combined oxygen-ozone and corticosteroid<br>* Subacromial injection using Ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The visual analog scale (VAS) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Murley Score (CMS) |  | 3 months |