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

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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tendinopathy
• Intervention / Treatment: Procedure: Ozone (O2-O3) injection; Procedure: Corticosteroid injection

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Cankaya
    • Ankara, Cankaya, Turkey, 06100
      • Merve Orucu Atar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ozone (O2-O3) group; Ultrasound (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).	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).
Other: Corticosteroid group; US-guided injection 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).	Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: December 25, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: ultrasonography; steroid; ozone; rotator cuff tendinopathy
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: 26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No