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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozone (O2-O3) group | Active Comparator | 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). |
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| Corticosteroid group | Other | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozone (O2-O3) injection | Procedure | 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). |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasonographic measurements | supraspinatus tendon thickness, subacromial bursa thickness and acromiohumeral distance will be measured by US in both groups | at baseline and change from baseline ultrasonographic measurements at 4 weeks and 12 weeks after injections |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merve Örücü Atar | Ankara | Cankaya | 06100 | Turkey (Türkiye) |
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Outcome measures will be evaluated by an independent physiatrist, blinded for the assigned treatment.
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| Corticosteroid injection | Procedure | 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). |
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| 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 |
| ID | Term |
|---|---|
| D010126 | Ozone |
| D007267 | Injections |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D010100 | Oxygen |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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