NCT05304884

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2022

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

March 22, 2022

Last Update Submit

March 22, 2022

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • The visual analog scale (VAS)

    3 months

Secondary Outcomes (1)

  • Constant Murley Score (CMS)

    3 months

Study Arms (3)

single dose ozone

ACTIVE COMPARATOR

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

Combination Product: combined oxygen-ozone and corticosteroid

three doses of ozone

ACTIVE COMPARATOR

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

Combination Product: combined oxygen-ozone and corticosteroid

corticosteroid

ACTIVE COMPARATOR

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

Combination Product: combined oxygen-ozone and corticosteroid

Interventions

combined oxygen-ozone and corticosteroidCOMBINATION_PRODUCT

Subacromial injection using Ultrasound

corticosteroidsingle dose ozonethree doses of ozone

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTU Medical Faculty

Merkez, Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Interventions were perfored by a physician and study outcomes were assessed by another physician.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 31, 2022

Study Start

June 30, 2021

Primary Completion

February 22, 2022

Study Completion

March 22, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

TU(1)