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NCT Number: NCT07240155

Ozone Therapy in 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.

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Key information

Conditions

Tennis Elbow Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Merve Demir Benli

Izmir, Balçova, 35340, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ozone treatment

Device

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.

Other names: home-based exercise therapy

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

    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).

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Collaborators

  • Izmir Ataturk Training and Research Hospital

Registry information

Official study title

COMPARATIVE EFFICACY OF OZONE INJECTIONS AND HOME-BASED EXERCISE ON LATERAL EPICONDYLOPATHY

Acronym: O2-O3

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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