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

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status: Completed

Conditions: Rotator Cuff Tendinopathy

Treatments: Procedure: Ozone (O2-O3) injection; Procedure: Corticosteroid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05207384

26

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Ozone (O2-O3) group

Active Comparator group

Description:

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).

Treatment:

Procedure: Ozone (O2-O3) injection

Corticosteroid group

Other group

Description:

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).

Treatment:

Procedure: Corticosteroid injection