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Ozone Injection for Shoulder Impengement Syndrome

NCT ID: NCT05304884

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2022-03-22

Brief Summary

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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).

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Interventions were perfored by a physician and study outcomes were assessed by another physician.

Study Groups

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single dose ozone

Group 1 received a single dose ozone injection (n:36)

Group Type ACTIVE_COMPARATOR

combined oxygen-ozone and corticosteroid

Intervention Type COMBINATION_PRODUCT

Subacromial injection using Ultrasound

three doses of ozone

Group 2 (n:36) received three doses of ozone injection (n :36).

Group Type ACTIVE_COMPARATOR

combined oxygen-ozone and corticosteroid

Intervention Type COMBINATION_PRODUCT

Subacromial injection using Ultrasound

corticosteroid

Group 3 (n:36) was treated with a corticosteroid injection

Group Type ACTIVE_COMPARATOR

combined oxygen-ozone and corticosteroid

Intervention Type COMBINATION_PRODUCT

Subacromial injection using Ultrasound

Interventions

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combined oxygen-ozone and corticosteroid

Subacromial injection using Ultrasound

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Karadeniz Technical University

OTHER

Sponsor Role collaborator

Erzurum Regional Training & Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mehmet Cenk Turgut

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KTU Medical Faculty

Merkez, Trabzon, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2021/11/177

Identifier Type: -

Identifier Source: org_study_id