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

NCT05207384 | Completed

• 1 other identifier: 26
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tendinopathy

Keywords

rotator cuff tendinopathy; ozone; steroid; ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Shoulder Pain and Disability Index (SPADI)

  at baseline and change from baseline SPADI at 4 weeks and 12 weeks after injections

• Visual Analogue Scale (VAS)

  at baseline and change from baseline VAS at 4 weeks and 12 weeks after injections

Other Outcomes (1)

• Ultrasonographic measurements

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

Study Arms (2)

Ozone (O2-O3) group

ACTIVE COMPARATOR

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

Corticosteroid group

OTHER

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

Interventions

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).

Ozone (O2-O3) group

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).

Corticosteroid group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Merve Örücü Atar

Ankara, Cankaya, 06100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Ozone; Injections; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures will be evaluated by an independent physiatrist, blinded for the assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Associate Professor

Study Record Dates

• First Submitted: December 25, 2021
• First Posted: January 26, 2022
• Study Start: January 27, 2022
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)