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

February 16, 2026 updated by: Ankara City Hospital Bilkent

Comparison of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) and Ultrasound-Guided Ozone Injection Therapy in Patients With Resistant Lateral Epicondylitis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Lateral epicondylitis is a painful and often debilitating tendinopathy affecting the common extensor tendon origin. Although most patients respond to standard conservative management, a substantial proportion progress to a chronic, refractory condition. For these resistant cases, identifying effective and minimally invasive treatment options remains a significant clinical challenge.

Extracorporeal Shock Wave Therapy (ESWT) is a non-invasive modality widely used in the management of chronic tendinopathies. Its proposed therapeutic mechanisms include the induction of controlled microtrauma, stimulation of neoangiogenesis, increased local blood flow, and modulation of pain-related signaling pathways, ultimately promoting tissue regeneration.

Medical ozone therapy has emerged as a potential regenerative injection approach. The local administration of an oxygen-ozone gas mixture into the affected tissue is thought to exert anti-inflammatory effects, enhance tissue oxygenation, and stimulate fibroblast activity, thereby supporting cellular repair processes within degenerated tendon tissue.

Although both modalities demonstrate potential therapeutic benefits, direct comparative evidence regarding their effectiveness in chronic, treatment-resistant lateral epicondylitis remains limited. This study aims to compare the clinical and structural outcomes associated with these two treatment approaches. By evaluating both symptom improvement and objective ultrasonographic tendon changes, this trial seeks to provide evidence to inform optimal treatment strategies for chronic cases.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
  • Trauma: History of direct trauma to the elbow.
  • Medication: Current use of medications that may affect pain levels or muscle strength (e.g., muscle relaxants, analgesics, gabapentinoids).
  • Local Infection: Presence of open wounds, infection, or signs of active inflammation in the elbow region.
  • Cooperation: Difficulty in cooperation or cognitive inability to follow instructions.
  • Enzyme Deficiency: Congenital Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ESWT Group
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
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.
Active Comparator: Ozone Injection Group
This group consists of patients diagnosed with lateral epicondylitis resistant to conservative treatment who are randomly allocated to the injection arm.
Other: ozone injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: Baseline, immediately after treatment completion, and 4 weeks after treatment completion.
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)
Time Frame: Baseline, immediately after treatment completion, and 4 weeks after treatment completion.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip Strength
Time Frame: Baseline, immediately after treatment completion, and 4 weeks after treatment completion.
Grip strength was measured using a hand-held dynamometer. Measurements were recorded in kilograms
Baseline, immediately after treatment completion, and 4 weeks after treatment completion.
Ultrasonographic Evaluation (Common Extensor Tendon Thickness and Spur Presence)
Time Frame: Baseline, immediately after treatment completion, and 4 weeks after treatment completion
Ultrasonographic assessment included two parameters: 1) The thickness of the common extensor tendon (CET) measured in millimeters (mm) in the longitudinal plane, and 2) The presence or absence of bony spurs at the lateral epicondyle.
Baseline, immediately after treatment completion, and 4 weeks after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Berke Aras, Medical Doctor, Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

March 3, 2026

Study Completion (Estimated)

March 3, 2026

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2-25-11166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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