NCT07427368 Comparison of ESWT and Ultrasound-Guided Ozone Injection in Lateral Epicondylitis
| NCT ID | NCT07427368 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ankara City Hospital Bilkent |
| Condition | Epicondylitis, Lateral |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-03-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-06-01 with a primary completion date of 2026-03-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Berke Aras, Medical Doctor
PRINCIPAL INVESTIGATOR
Ankara City Hospital Bilkent
Frequently Asked Questions
Who can join the NCT07427368 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Epicondylitis, Lateral. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07427368 currently recruiting?
Yes, NCT07427368 is actively recruiting participants. Contact the research team at duyguelbasi@gmail.com for enrollment information.
Where is the NCT07427368 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07427368 clinical trial?
NCT07427368 is sponsored by Ankara City Hospital Bilkent. The principal investigator is Berke Aras, Medical Doctor at Ankara City Hospital Bilkent. The trial plans to enroll 50 participants.