Ozone Therapy in Lateral Epicondylopathy

NCT07240155 | Completed

• 1 other identifier: Atatürk Education and Research
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Tennis Elbow

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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.

Study Arms (1)

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

Device: Ozone treatment

Interventions

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.

Also known as: home-based exercise therapy

Ozone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Dokuz Eylul University: lead
• Izmir Ataturk Training and Research Hospital: collaborator

Study Sites (1)

Merve Demir Benli

Izmir, Balçova, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: November 20, 2025
• Study Start: November 1, 2022
• Primary Completion: April 3, 2023
• Study Completion: April 24, 2023
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

TU (1)