CompletedNot Applicable

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

Turkey (Türkiye)44 participantsStarted 2022-01-27

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Western Ontario Rotator Cuff Index (WORC)

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

Trial details

NCT IDNCT05207384

SponsorGaziler Physical Medicine and Rehabilitation Education and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-20

View on ClinicalTrials.gov More Rotator Cuff Tendinopathy trials