Comparison of ESWT and Ultrasound-Guided Ozone Injection in Lateral Epicondylitis

NCT07427368 | Recruiting

• 1 other identifier: E2-25-11166
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Lateral epicondylitis is a common and often debilitating condition characterized by pain over the lateral aspect of the elbow. Although many patients respond to standard conservative treatments, a subset develops a chronic and treatment-resistant form of the condition. The primary objective of this randomized comparative clinical trial is to evaluate and compare the therapeutic effectiveness of two intervention modalities: Extracorporeal Shock Wave Therapy (ESWT) and ultrasound-guided ozone injection in patients with chronic lateral epicondylitis. Participants who meet the inclusion criteria will be randomly assigned to one of two treatment arms. The first group will receive Extracorporeal Shock Wave Therapy (ESWT), while the second group will receive an ultrasound-guided injection of an ozone-oxygen mixture. Both interventions will be administered once weekly for three consecutive weeks according to their respective standard treatment protocols. To determine which treatment yields superior clinical and structural outcomes, participants will be evaluated at three time points: baseline (prior to treatment), immediately after completion of the 3-week treatment protocol, and at a 4-week follow-up. Outcome measures will include pain intensity assessed using the Visual Analog Scale (VAS), functional status evaluated with the Patient-Rated Tennis Elbow Evaluation (PRTEE), hand grip strength measured with a dynamometer, and structural tendon changes (tendon thickness and presence of enthesophytes) assessed by high-resolution ultrasonography.

Conditions

Epicondylitis, Lateral

Keywords

ozone therapy; ESWT; Extracorporeal Shockwave Therapy; tennis elbow; Oxygen-Ozone Therapy; lateral epiconylitis

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS)

  Pain intensity was evaluated using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain.

  Baseline, immediately after treatment completion, and 4 weeks after treatment completion.

• Patient-Rated Tennis Elbow Evaluation (PRTEE)

  Functional disability was assessed using the PRTEE questionnaire. The total score ranges from 0 (no disability) to 100 (significant functional disability).

  Baseline, immediately after treatment completion, and 4 weeks after treatment completion.

Secondary Outcomes (2)

• Grip Strength

  Baseline, immediately after treatment completion, and 4 weeks after treatment completion.

• Ultrasonographic Evaluation (Common Extensor Tendon Thickness and Spur Presence)

  Baseline, immediately after treatment completion, and 4 weeks after treatment completion

Study Arms (2)

ESWT Group

ACTIVE COMPARATOR

This group consists of patients diagnosed with lateral epicondylitis resistant to conservative treatment who are randomly allocated to the extracorporeal shock wave therapy arm.

Device: ESWT Device

Ozone Injection Group

ACTIVE COMPARATOR

This group consists of patients diagnosed with lateral epicondylitis resistant to conservative treatment who are randomly allocated to the injection arm.

Other: ozone injection

Interventions

ESWT Device DEVICE

Application of extracorporeal shock waves targeted at the common extensor tendon origin at the lateral epicondyle. The therapeutic procedure is performed once a week for 3 consecutive weeks, totaling 3 sessions. Each session includes 2000 impulses.

ESWT Group

ozone injection OTHER

Injection of a medical oxygen-ozone gas mixture directly into the common extensor tendon origin at the lateral epicondyle. To ensure precise anatomical localization and safety, the procedure is performed under real-time high-resolution ultrasound guidance and strict sterile conditions. The injection is administered once a week for 3 consecutive weeks, totaling 3 sessions.

Ozone Injection Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Male or female patients between 18 and 65 years of age.
• Clinical Diagnosis: Patients diagnosed with lateral epicondylitis, defined by pain in the lateral epicondyle region for more than 3 months, increased pain on palpation of the lateral epicondyle, and positive provocation tests (Cozen's, Maudsley's, or Mills' tests).
• Symptom Duration: Presence of symptoms for more than 3 months (resistant cases).
• Treatment Failure: Lack of response to first-line conservative treatments (e.g., analgesics, exercise, rest, splinting).
• Radiographic Confirmation: No other pathology detected on direct radiographs of the elbow.
• Injection History: No corticosteroid injection to the affected elbow within the last 6 months.
• Consent: Voluntary participation in the study

You may not qualify if:

• Elbow Pathology: Presence of elbow problems other than lateral epicondylitis (e.g., loose bodies, rheumatoid nodules).
• Surgical History: History of previous surgery on the affected elbow joint.
• Structural Damage: Presence of tendon rupture.
• Consent: Unwillingness to continue treatment or participate.
• Spinal Pathology: Cervical root pathology (cervical radiculopathy).
• Neuropathy: Diagnosed upper extremity entrapment neuropathy.
• Neurological Status: Presence of neurological impairment or deficits.
• Recent Injections: History of injection therapy to the elbow within the last 6 months.
• Recent Therapy: History of physical therapy for the elbow region within the last 6 months.
• Pregnancy: Pregnant women.
• Hematological: Presence of coagulation or bleeding disorders.
• Vascular: Presence of peripheral vasculopathy.
• Pain Syndromes: Presence of Complex Regional Pain Syndrome (CRPS).
• Oncology: History of malignancy.
• Systemic Diseases: Presence of systemic inflammatory or autoimmune disorders (e.g., Rheumatoid Arthritis, SLE).

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Interventions

Ozone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals

Study Officials

• Berke Aras, Medical Doctor

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duygu Elbaşı, Medical Doctor

CONTACT

+905544739970; duyguelbasi@gmail.com

Berke Aras, Medical Doctor

CONTACT

+905365851518; drberkearas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, comparative study designed to evaluate the efficacy of two different treatment modalities in patients with resistant lateral epicondylitis. Participants will be randomly assigned to two parallel groups (ESWT and Ozone) to compare clinical outcomes.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: June 1, 2025
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)