Ozone Injection for Shoulder Impengement Syndrome

Clinical and Functional Outcomes of a Single Dose Ozone, Three Doses of Ozone and Corticosteroid Injection in Patients With Shoulder Impingement Syndrome

Ozone injection has lately been utilized as a safe alternative to corticosteroids in the management of musculoskeletal diseases with fewer side effects. This study aimed to compare the effectiveness of a corticosteroid, single dose and three doses of ozone injection in shoulder impingement syndrome (SIS).

Study Overview

• Status: Completed
• Conditions: Research on the Effectiveness of a Corticosteroid, Single Dose and Three Doses of Ozone Injection in Shoulder Impingement Syndrome
• Intervention / Treatment: Combination product: combined oxygen-ozone and corticosteroid

Detailed Description

A hundred and eight SIS patients were divided into three groups and underwent subacromial injections in this prospective study. Group 1 received a single dose (n:36), group 2 (n:36) received three doses of ozone injection (n :36). Group 3 (n:36) was treated with a corticosteroid injection. Patients were evaluated using the visual analog scale (VAS) and Constant Murley Score (CMS), pre-injection and at 4 weeks and 12 weeks.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Trabzon
    • Merkez, Trabzon, Turkey
      • KTU Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: patients older than 18 years with shoulder pain lasting for more than three months, pain severity more than 5/10 on Visual Analog Scale (VAS), and diagnosed with SIS according to clinical examination and magnetic resonance imaging (MRI), were enrolled in this randomized clinical study.

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Exclusion Criteria: The exclusion criteria were as follows: existing pathological abnormalities such as full-thickness rotator cuff tears on MRI, any cause of shoulder pain other than SIS such as inflammatory joint diseases, shoulder osteoarthritis and adhesive capsulitis, restriction of shoulder range of motion, coagulation disorders or use of anticoagulants, previous history of shoulder trauma, surgery or fracture, history of any subacromial injection or physical therapy for the last year, contraindications for ozone injection such as known Glucose 6 phosphate dehydrogenase deficiency, pregnancy, uncontrolled hyperthyroidism, and leukemia.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: single dose ozone; Group 1 received a single dose ozone injection (n:36)	Combination product: combined oxygen-ozone and corticosteroid; Subacromial injection using Ultrasound
ACTIVE_COMPARATOR: three doses of ozone; Group 2 (n:36) received three doses of ozone injection (n :36).	Combination product: combined oxygen-ozone and corticosteroid; Subacromial injection using Ultrasound
ACTIVE_COMPARATOR: corticosteroid; Group 3 (n:36) was treated with a corticosteroid injection	Combination product: combined oxygen-ozone and corticosteroid; Subacromial injection using Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The visual analog scale (VAS)	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Constant Murley Score (CMS)	3 months

Collaborators and Investigators

• Sponsor: Erzurum Regional Training & Research Hospital
• Collaborators: Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2021
• Primary Completion (ACTUAL): February 22, 2022
• Study Completion (ACTUAL): March 22, 2022

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (ACTUAL): March 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Syndrome; Shoulder Impingement Syndrome
• Other Study ID Numbers: 2021/11/177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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