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Ozone Injection for Shoulder Impengement Syndrome

E

Erzurum Regional Training & Research Hospital

Status and phase

Completed
Phase 4

Conditions

Research on the Effectiveness of a Corticosteroid, Single Dose and Three Doses of Ozone Injection in Shoulder Impingement Syndrome

Treatments

Combination Product: combined oxygen-ozone and corticosteroid

Study type

Interventional

Funder types

Other

Identifiers

NCT05304884
2021/11/177

Details and patient eligibility

About

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).

Full 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.

Enrollment

108 patients

Sex

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

108 participants in 3 patient groups

single dose ozone
Active Comparator group
Description:
Group 1 received a single dose ozone injection (n:36)
Treatment:
Combination Product: combined oxygen-ozone and corticosteroid
three doses of ozone
Active Comparator group
Description:
Group 2 (n:36) received three doses of ozone injection (n :36).
Treatment:
Combination Product: combined oxygen-ozone and corticosteroid
corticosteroid
Active Comparator group
Description:
Group 3 (n:36) was treated with a corticosteroid injection
Treatment:
Combination Product: combined oxygen-ozone and corticosteroid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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