Ozone Therapy in Lateral Epicondylopathy

Not Applicable

Completed

• Conditions: Tennis Elbow

• Registration Number: NCT07240155
• Lead Sponsor: Dokuz Eylul University

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.

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2023-04-03
• Study Completion: 2023-04-24
• Study First Submitted: 2024-07-19
• Status Verified: 2025-11
• Study First Submitted QC: 2025-11-19
• Last Update Submitted: 2025-11-19
• Study First Posted: 2025-11-20
• Last Update Posted: 2025-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)	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.
Visual Analog Scale	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)	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.

Secondary Outcome Measures

Name	Time	Method
European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)	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).

Trial Locations

Locations (1)

Merve Demir Benli; Izmir, Balçova, Turkey (Türkiye)