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

Not Applicable

Completed

• Conditions: Rotator Cuff Tendinopathy
• Interventions: Procedure: Ozone (O2-O3) injection; Procedure: Corticosteroid injection

• Registration Number: NCT05207384
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-12-25
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-26
• Study Start: 2022-01-27
• Primary Completion: 2022-05-20
• Study Completion: 2022-05-20
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozone (O2-O3) group	Ozone (O2-O3) injection	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).
Corticosteroid group	Corticosteroid injection	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).

Primary Outcome Measures

Name	Time	Method
The Western Ontario Rotator Cuff Index (WORC)	at baseline and change from baseline WORC at 4 weeks and 12 weeks after injections	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.

Secondary Outcome Measures

Name	Time	Method
The Shoulder Pain and Disability Index (SPADI)	at baseline and change from baseline SPADI at 4 weeks and 12 weeks after injections	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.
Visual Analogue Scale (VAS)	at baseline and change from baseline VAS at 4 weeks and 12 weeks after injections	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))

Trial Locations

Locations (1)

Merve Örücü Atar; 🇹🇷 Ankara, Cankaya, Turkey