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Ozone Injection for Shoulder Impengement Syndrome

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
combined oxygen-ozone and corticosteroid
Sponsored by
Erzurum Regional Training & Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Research on the Effectiveness of a Corticosteroid, Single Dose and Three Doses of Ozone Injection in Shoulder Impingement Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept 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.

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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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Sites / Locations

  • KTU Medical Faculty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

single dose ozone

three doses of ozone

corticosteroid

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

The visual analog scale (VAS)

Secondary Outcome Measures

Constant Murley Score (CMS)

Full Information

First Posted
March 22, 2022
Last Updated
March 22, 2022
Sponsor
Erzurum Regional Training & Research Hospital
Collaborators
Karadeniz Technical University
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1. Study Identification

Unique Protocol Identification Number
NCT05304884
Brief Title
Ozone Injection for Shoulder Impengement Syndrome
Official Title
Clinical and Functional Outcomes of a Single Dose Ozone, Three Doses of Ozone and Corticosteroid Injection in Patients With Shoulder Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
February 22, 2022 (Actual)
Study Completion Date
March 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erzurum Regional Training & Research Hospital
Collaborators
Karadeniz Technical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Research on the Effectiveness of a Corticosteroid, Single Dose and Three Doses of Ozone Injection in Shoulder Impingement Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Interventions were perfored by a physician and study outcomes were assessed by another physician.
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single dose ozone
Arm Type
Active Comparator
Arm Description
Group 1 received a single dose ozone injection (n:36)
Arm Title
three doses of ozone
Arm Type
Active Comparator
Arm Description
Group 2 (n:36) received three doses of ozone injection (n :36).
Arm Title
corticosteroid
Arm Type
Active Comparator
Arm Description
Group 3 (n:36) was treated with a corticosteroid injection
Intervention Type
Combination Product
Intervention Name(s)
combined oxygen-ozone and corticosteroid
Intervention Description
Subacromial injection using Ultrasound
Primary Outcome Measure Information:
Title
The visual analog scale (VAS)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Constant Murley Score (CMS)
Time Frame
3 months

10. Eligibility

Accepts Healthy Volunteers
No
Eligibility 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. -
Facility Information:
Facility Name
KTU Medical Faculty
City
Merkez
State/Province
Trabzon
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Ozone Injection for Shoulder Impengement Syndrome

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