Ozone Therapy in Lateral Epicondylopathy (O2-O3)

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.

Study Overview

• Status: Completed
• Conditions: Tennis Elbow
• Intervention / Treatment: Device: Ozone treatment

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Balçova
    • Izmir, Balçova, Turkey (Türkiye), 35340
      • Merve Demir Benli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ozone; 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

Device: Ozone treatment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Quick-DASH values were measured before treatment, one month and three months after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	EQ-5D-3L values were measured before treatment, one month and three months after treatment.

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Collaborators: Izmir Ataturk Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): April 3, 2023
• Study Completion (Actual): April 24, 2023

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Elbow Tendinopathy; Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Tendinopathy; Tennis Elbow
• Other Study ID Numbers: Atatürk Education and Research

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No