Ozone Injection for Shoulder Impengement Syndrome

Sponsor

Erzurum Regional Training & Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05304884

Collaborator

Karadeniz Technical University (Other)

108

Enrollment

Location

Arms

8.7

Actual Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Research on the Effectiveness of a Corticosteroid, Single Dose and Three Doses of Ozone Injection in Shoulder Impingement Syndrome	Combination Product: combined oxygen-ozone and corticosteroid	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 30, 2021

Actual Primary Completion Date :

Feb 22, 2022

Actual Study Completion Date :

Mar 22, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The visual analog scale (VAS) [3 months]

Secondary Outcome Measures

Constant Murley Score (CMS) [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KTU Medical Faculty	Merkez	Trabzon	Turkey

Sponsors and Collaborators

Erzurum Regional Training & Research Hospital
Karadeniz Technical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mehmet Cenk Turgut, MD, Erzurum Regional Training & Research Hospital

ClinicalTrials.gov Identifier:

NCT05304884

Other Study ID Numbers:

2021/11/177

First Posted:

Mar 31, 2022

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shoulder Impingement Syndrome

Syndrome

Study Results

No Results Posted as of Mar 31, 2022