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

N/ACompletedNCT05207384

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Rotator Cuff Tendinopathy

Interventions

Ozone (O2-O3) injectionPROCEDURE

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 injectionPROCEDURE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Merve Örücü Atar

Ankara, Cankaya, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: at baseline and change from baseline WORC at 4 weeks and 12 weeks after injections

Secondary Outcomes

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.

Time frame: 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))

Time frame: at baseline and change from baseline VAS at 4 weeks and 12 weeks after injections

Data from ClinicalTrials.gov

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