Comparison of Subacromial Ozone (O2-O3) and Corticosteroid Injections in the Treatment of Rotator Cuff Tendinopathy

Study Overview
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Brief Summary
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Shoulder pain accounts for approximately 16% of all musculoskeletal symptoms. Rotator cuff tendinopathy is the most common cause of shoulder pain. The aim of this study is to compare the effects of ultrasound-guided subacromial ozone (O2-O3) versus corticosteroid injection in patients with chronic rotator cuff tendinopathy.

Detailed Description
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Shoulder pain accounts for approximately 16% of all musculoskeletal symptoms. Rotator cuff tendinopathy is the most common cause of shoulder pain. There are limited studies comparing the efficacy of ozone and corticosteroid injections in rotator cuff tendinopathy. In this context, the aim of this study is to compare the effects of ultrasound-guided subacromial ozone (O2-O3) versus corticosteroid injection in patients with chronic rotator cuff tendinopathy.

Official Title
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Comparison of Ultrasound-Guided Subacromial Ozone (O2-O3) and Corticosteroid Injections in the Treatment of Chronic Rotator Cuff Tendinopathy: A Randomized Controlled Trial

Conditions
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Rotator Cuff Tendinopathy

Intervention / Treatment
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* Procedure: Ozone (O2-O3) injection
* Procedure: Corticosteroid injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 18 and 70 years pain in the shoulder region and increase in pain with overhead-throwing activity chronic shoulder pain for more than 3 months partial rotator cuff tear or rotator cuff tendinosis diagnosed by US or magnetic resonance imaging (MRI). Exclusion Criteria: a full-thickness rotator cuff tear diagnosed by US or MRI allergic reaction betamethasone or lidocaine contraindications for ozone (O2-O3) injection, such as uncontrolled hyperthyroidism, glucose-6 phosphate dehydrogenase deficiency (G6PDD), pregnancy and platelet level <50 103/µL history of coagulopathy, diabetes, or hepatitis intra-articular/subacromial injections in the last 3 months history of shoulder infection, fracture, trauma, bony lesion, tumor or inflammatory rheumatic diseases history of brachial plexus lesion/cervical radiculopathy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ozone (O2-O3) group<br>Ultrasound (US)-guided injections will be performed with a 5-12 MHz linear transducer (Logic e portable; GE Healthcare, China) by the same physiatrist and injections will be administered into the subacromial bursa with a posterolateral approach. 3 sessions (1 session/week) of 5 mL of ozone (O2-O3) will be injected (with a concentration of 10 μg/mL in the first session, 15 μg/mL in the second session, and 20 μg/mL in the third session). | Procedure: Ozone (O2-O3) injection<br>* US-guided injections will be performed with a 5-12 MHz linear transducer (Logic e portable; GE Healthcare, China) by the same physiatrist and injections will be administered into the subacromial bursa with a posterolateral approach. 3 sessions (1 session/week) of 5 mL of ozone (O2-O3) will be injected (with a concentration of 10 μg/mL in the first session, 15 μg/mL in the second session, and 20 μg/mL in the third session).<br>|
| Other: Corticosteroid group<br>US-guided injection will be performed with a 5-12 MHz linear transducer (Logic e portable; GE Healthcare, China) by the same physiatrist and injections will be administered into the subacromial bursa with a posterolateral approach. A mixture of 1 mL corticosteroid (betamethasone 3 mg/mL) and 1 mL lidocaine (20 mg) will be injected (1 session). | Procedure: Corticosteroid injection<br>* US-guided injections will be performed with a 5-12 MHz linear transducer (Logic e portable; GE Healthcare, China) by the same physiatrist and injections will be administered into the subacromial bursa with a posterolateral approach. A mixture of 1 mL corticosteroid (betamethasone 3 mg/mL) and 1 mL lidocaine (20 mg) will be injected (1 session).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Western Ontario Rotator Cuff Index (WORC) | The Western Ontario Rotator Cuff Index (WORC) is a self-administered assessment tool for rotator cuff disease. WORC has 21 questions in 5 domains consisting of work, physical symptoms, social well-being, emotional well-being, and sports and recreation. Each question is scored on a 100-mm, with higher scores demonstrating larger problems. Turkish validity of the WORC has been illustrated. | at baseline and change from baseline WORC at 4 weeks and 12 weeks after injections | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Shoulder Pain and Disability Index (SPADI) | The Shoulder Pain and Disability Index (SPADI) is a 13 item self-assessment measurement tool to evaluate disability (8 items) and pain (5 items). The subscales of disability and pain are measured as the average of the corresponding items between 0-100, with higher scores indicating greater disability and pain. | at baseline and change from baseline SPADI at 4 weeks and 12 weeks after injections | 
| Visual Analogue Scale (VAS) | The severity of the patients' shoulder pain in the last week will be evaluated using the 10-point VAS (from 0 (no pain) to 10 (worst imaginable pain)) | at baseline and change from baseline VAS at 4 weeks and 12 weeks after injections | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotator cuff tendinopathy, ozone, steroid, ultrasonography