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

Rotator Cuff Tendinopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05207384
• Other study ID #: 26
• Status: Completed
• Phase: N/A
• Start date: January 27, 2022
• Est. completion date: May 20, 2022

Study information

• Verified date: June 2022
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Tendinopathy
• Tendinopathy

Intervention

Procedure:
• Ozone (O2-O3) injection
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
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).

Locations

Country	Name	City	State
Turkey	Merve Örücü Atar	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ultrasonographic measurements	supraspinatus tendon thickness, subacromial bursa thickness and acromiohumeral distance will be measured by US in both groups	at baseline and change from baseline ultrasonographic measurements at 4 weeks and 12 weeks after injections
Primary	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.	at baseline and change from baseline WORC at 4 weeks and 12 weeks after injections
Secondary	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.	at baseline and change from baseline SPADI at 4 weeks and 12 weeks after injections
Secondary	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))	at baseline and change from baseline VAS at 4 weeks and 12 weeks after injections