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NCT Number: NCT05207384

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

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.

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Key information

Conditions

Rotator Cuff Tendinopathy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Merve Örücü Atar

Ankara, Cankaya, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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).

Primary outcomes

  1. The Western Ontario Rotator Cuff Index (WORC)

    Time frame: 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 outcomes

  1. The Shoulder Pain and Disability Index (SPADI)

    Time frame: 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.

  2. Visual Analogue Scale (VAS)

    Time frame: 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))

Other outcomes

  1. Ultrasonographic measurements

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

    supraspinatus tendon thickness, subacromial bursa thickness and acromiohumeral distance will be measured by US in both groups

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2022
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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