Clinical trial NCT05207384: Comparison of Subacromial Ozone (O2-O3) and Corticosteroid Injections in the Treatment of Rotator Cuff Tendinopathy
Official title: Comparison of Ultrasound-Guided Subacromial Ozone (O2-O3) and Corticosteroid Injections in the Treatment of Chronic Rotator Cuff Tendinopathy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tendinopathy
Keywords: rotator cuff tendinopathy
ozone
steroid
ultrasonography
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Western Ontario Rotator Cuff Index (WORC)
timeFrame: at baseline and change from baseline WORC at 4 weeks and 12 weeks after injections
Secondary outcomes:
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: at baseline and change from baseline SPADI at 4 weeks and 12 weeks after injections
measure: Visual Analogue Scale (VAS)
timeFrame: at baseline and change from baseline VAS at 4 weeks and 12 weeks after injections
Other outcomes:
measure: Ultrasonographic measurements
timeFrame: at baseline and change from baseline ultrasonographic measurements at 4 weeks and 12 weeks after injections
Locations:
city: Ankara
country: Turkey
facility: Merve Örücü Atar
state: Cankaya
Study officials:
References: