Ozone Therapy in Lateral Epicondylopathy

NCT ID: NCT07240155

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-04-24

Brief 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. 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.

Conditions

Tennis Elbow

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Ozone treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

home-based exercise therapy

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Izmir Ataturk Training and Research Hospital

OTHER

Sponsor Role: collaborator

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Merve Demir Benli

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Merve Demir Benli

Izmir, Balçova, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Atatürk Education and Research

Identifier Type: -

Identifier Source: org_study_id