Research on the Effectiveness of a Corticosteroid, Single Dose and Three Doses of Ozone Injection in Shoulder Impingement SyndromePhase 4NCT05304884

Ozone Injection for Shoulder Impengement Syndrome

A Phase 4 study testing combined oxygen-ozone and corticosteroid in people with Research on the Effectiveness of a Corticosteroid, Single Dose and Three Doses of Ozone Injection in Shoulder Impingement Syndrome, run by Erzurum Regional Training & Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Any age
Conditions the study is for: Research on the Effectiveness of a Corticosteroid, Single Dose and Three Doses of Ozone Injection in Shoulder Impingement Syndrome
What is being tested?: combined oxygen-ozone and corticosteroid
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 30 Jun 2021to 22 Mar 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
No healthy volunteers
Child, Adult, Older adult

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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

KTU Medical Faculty
Merkez, Trabzon

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Conditions: Research on the Effectiveness of a Corticosteroid, Single Dose and Three Doses of Ozone Injection in Shoulder Impingement Syndrome
Being tested: combined oxygen-ozone and corticosteroid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

combined oxygen-ozone and corticosteroidCombination product
Subacromial injection using Ultrasound

Study groups in NCT05304884
Study group	Role	What they receive
single dose ozone	Active comparator	Group 1 received a single dose ozone injection (n:36) Receives: 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). Receives: Combination Product: combined oxygen-ozone and corticosteroid
corticosteroid	Active comparator	Group 3 (n:36) was treated with a corticosteroid injection Receives: Combination Product: combined oxygen-ozone and corticosteroid

What is being measured

The primary outcome is the main question the study is designed to answer.

The visual analog scale (VAS)
Measured: 3 months

Secondary outcomes (1)

Constant Murley Score (CMS)
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202122 Mar 2022

First posted31 Mar 2022
Study start30 Jun 2021
Primary completion22 Feb 2022
Study completion22 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Research on the Effectiveness of a Corticosteroid, Single Dose and Three Doses of Ozone Injection in Shoulder Impingement SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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: Single blind
Who is masked: Outcomes assessor
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05304884
Sponsor's protocol ID: 2021/11/177
Status last verified: Mar 2022
First submitted: 22 Mar 2022
Last updated: 31 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical and Functional Outcomes of a Single Dose Ozone, Three Doses of Ozone and Corticosteroid Injection in Patients With Shoulder Impingement Syndrome
ClinicalTrials.gov ID: NCT05304884
Acronym / sponsor ID: 2021/11/177
Conditions: Research on the Effectiveness of a Corticosteroid, Single Dose and Three Doses of Ozone Injection in Shoulder Impingement Syndrome
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Erzurum Regional Training & Research HospitalOther government
Collaborators: Karadeniz Technical University
Study start: 30 Jun 2021 (actual)
Primary completion: 22 Feb 2022 (actual)
Study completion: 22 Mar 2022 (actual)
First posted: 31 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
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.

Arm	Type	Receives
single dose ozone	Active comparator	Combination Product: combined oxygen-ozone and corticosteroidGroup 1 received a single dose ozone injection (n:36)
three doses of ozone	Active comparator	Combination Product: combined oxygen-ozone and corticosteroidGroup 2 (n:36) received three doses of ozone injection (n :36).
corticosteroid	Active comparator	Combination Product: combined oxygen-ozone and corticosteroidGroup 3 (n:36) was treated with a corticosteroid injection

Who may qualify

Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
combined oxygen-ozone and corticosteroidSubacromial injection using Ultrasound	Combination product	corticosteroid, single dose ozone, three doses of ozone

Primary outcome

The visual analog scale (VAS)
Time frame: 3 months

1 secondary outcome

Constant Murley Score (CMS)
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The visual analog scale (VAS) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05304884.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.