Tennis ElbowO2-O3NCT07240155
Ozone Therapy in Lateral Epicondylopathy
A study testing Ozone treatment in people with Tennis Elbow, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Lateral epicondylopathy (LE) is a common cause of elbow pain. In the literature, there are few studies evaluating the efficacy of ozone injection in LE. To our knowledge, there is no study comparing it with exercise therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Ozone treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 24 Apr 2023
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion criteria were that the patients' age was ranged from 18 to 65, they were diagnosed with lateral epicondylitis, and they received ozone or exercise therapy, and had sufficient data.
Exclusion criteria consisted of any injections for LE within last six months, arthritis, effusion around the elbow, infection or trauma involving lateral epicondylar region, any previous fractures of the forearm or upper arm, physiotherapy within last six months, deformities or neurological deficits of the upper extremity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARATIVE EFFICACY OF OZONE INJECTIONS AND HOME-BASED EXERCISE ON LATERAL EPICONDYLOPATHY
Lateral epicondylopathy (LE) is a common cause of elbow pain. In the literature, there are few studies evaluating the efficacy of ozone injection in LE. To our knowledge, there is no study comparing it with exercise therapy. This study aims to investigate the efficacy of home-based exercise and ozone therapy on pain, functionality and quality of life in LE.
Read the detailed description
Introduction: Lateral epicondylopathy (LE) is a common cause of elbow pain. In the literature, there are few studies evaluating the efficacy of ozone injection in LE. To our knowledge, there is no study comparing it with exercise therapy. This study aims to investigate the efficacy of home-based exercise and ozone therapy on pain, functionality and quality of life in LE. A rehabilitation hospital associated with a community-based tertiary medical center. In this study, 65 patients with clinically diagnosed LE received either home-based exercise (Group 1), ozone injections (Group 2). Data from 59 patients were analyzed.
- Conditions
- Tennis Elbow
- Being tested
- Ozone treatment
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone treatmentDevice
Also called home-based exercise therapy
tThe home-based exercise consisted of streching, strenghtening for wrist and elbow. Participants implemented the home exercise program once a day, every day of the week.
| Study group | Role | What they receive |
|---|---|---|
| Ozone | Experimental | The ozone therapy sessions were applied while the patient was in the supine position. The location and depth of the injection points were identified through palpation. Povidone iodine has been used for sterilization. The injection site was cleaned in accordance with the aseptic antisepsis guidelines. The injection was applied at trigger points. First, the lateral epicondyle was determined and marked and then trigger points were determined and marked. After the skin was sterilized, injections were made using a 25-gauge 1.5-inch needle without applying local anesthesia to lateral epicondyle with 90° elbow flexion. In each session, 5-7 ml, 15μg/mL O2-O3 in trigger points for each region according to the Unification of Criteria in the Practice of Ozone Therapy (as described in the Madrid Declaration). Ozon injections were performed six times at 3-4 day intervals Receives: Device: Ozone treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
All the patients were examined for pain of elbow using a Visual Analog Scale (VAS) that rated the severity of pain on a scale of 0 to 10, where 0 indicated no pain and 10 signified severe pain.
Measured: VAS values were measured before treatment, one month and three months after treatment.
Patient-rated Tennis Elbow Evaluation (PRTEE)
PRTEE is a valid outcome measure for rating pain (PRTEE-pain) and disability (PRTEE-function) for forearm, that specifically developed for patient with LE. The scale has two parts, for pain (5 items) and function (10 items). Each item has a score from 0 to 10; a score of 10 refers to severe pain or inability to perform the activity.
Measured: PRTEE values were measured before treatment, one month and three months after treatment.
Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)
Quick-DASH questionnaire evaluates upper extremity disability levels. Quick-DASH contains 11 items (scored 1-5) that evaluate the daily living activities and severity of symptoms. A higher score indicates greater disability.
Measured: Quick-DASH values were measured before treatment, one month and three months after treatment.
Secondary outcomes (1)
European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
The EQ-5D-3L descriptive system consists of the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three levels: no problem (1 point), some problem (2 point), and extreme problem (3 point). The EQ-VAS records the patient's self-rated health on a vertical VAS where ranged from 0 (worst imaginable health state) - 100 (the best imaginable health state).
Measured: EQ-5D-3L values were measured before treatment, one month and three months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Nov 2022
- Primary completion3 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Ataturk Training and Research Hospital
- Responsible party
- Principal investigator, Merve Demir Benli, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240155
- Sponsor's protocol ID
- Atatürk Education and Research
- Acronym
- O2-O3
- Status last verified
- Nov 2025
- First submitted
- 19 Jul 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE EFFICACY OF OZONE INJECTIONS AND HOME-BASED EXERCISE ON LATERAL EPICONDYLOPATHY
- ClinicalTrials.gov ID
- NCT07240155
- Acronym / sponsor ID
- O2-O3 / Atatürk Education and Research
- Conditions
- Tennis Elbow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- Izmir Ataturk Training and Research Hospital
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 20 Nov 2025 (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.
Lateral epicondylopathy (LE) is a common cause of elbow pain. In the literature, there are few studies evaluating the efficacy of ozone injection in LE. To our knowledge, there is no study comparing it with exercise therapy. This study aims to investigate the efficacy of home-based exercise and ozone therapy on pain, functionality and quality of life in LE.
Detailed description
Introduction: Lateral epicondylopathy (LE) is a common cause of elbow pain. In the literature, there are few studies evaluating the efficacy of ozone injection in LE. To our knowledge, there is no study comparing it with exercise therapy. This study aims to investigate the efficacy of home-based exercise and ozone therapy on pain, functionality and quality of life in LE. A rehabilitation hospital associated with a community-based tertiary medical center. In this study, 65 patients with clinically diagnosed LE received either home-based exercise (Group 1), ozone injections (Group 2). Data from 59 patients were analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ozone | Experimental | Device: Ozone treatmentThe ozone therapy sessions were applied while the patient was in the supine position. The location and depth of the injection points were identified through palpation. Povidone iodine has been used for sterilization. The injection site was cleaned in accordance with the aseptic antisepsis guidelines. The injection was applied at trigger points. First, the lateral epicondyle was determined and marked and then trigger points were determined and marked. After the skin was sterilized, injections were made using a 25-gauge 1.5-inch needle without applying local anesthesia to lateral epicondyle with 90° elbow flexion. In each session, 5-7 ml, 15μg/mL O2-O3 in trigger points for each region according to the Unification of Criteria in the Practice of Ozone Therapy (as described in the Madrid Declaration). Ozon injections were performed six times at 3-4 day intervals |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 |
|---|---|---|
| Ozone treatmentAlso: home-based exercise therapytThe home-based exercise consisted of streching, strenghtening for wrist and elbow. Participants implemented the home exercise program once a day, every day of the week. | Device | Ozone |
Primary outcome
Visual Analog Scale
Time frame: VAS values were measured before treatment, one month and three months after treatment.
All the patients were examined for pain of elbow using a Visual Analog Scale (VAS) that rated the severity of pain on a scale of 0 to 10, where 0 indicated no pain and 10 signified severe pain.
Patient-rated Tennis Elbow Evaluation (PRTEE)
Time frame: PRTEE values were measured before treatment, one month and three months after treatment.
PRTEE is a valid outcome measure for rating pain (PRTEE-pain) and disability (PRTEE-function) for forearm, that specifically developed for patient with LE. The scale has two parts, for pain (5 items) and function (10 items). Each item has a score from 0 to 10; a score of 10 refers to severe pain or inability to perform the activity.
Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)
Time frame: Quick-DASH values were measured before treatment, one month and three months after treatment.
Quick-DASH questionnaire evaluates upper extremity disability levels. Quick-DASH contains 11 items (scored 1-5) that evaluate the daily living activities and severity of symptoms. A higher score indicates greater disability.
1 secondary outcome
European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
Time frame: EQ-5D-3L values were measured before treatment, one month and three months after treatment.
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 20 Nov 2025.
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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?
A study testing Ozone treatment in people with Tennis Elbow, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. 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.
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?
Visual Analog Scale (time frame: VAS values were measured before treatment, one month and three months after treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025.