Comparing shockwave therapy and ultrasound-guided oxygen-ozone injection for tennis elbow

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

This trial will see if shockwave therapy or an ultrasound-guided oxygen-ozone injection helps adults with chronic tennis elbow who haven't improved with standard treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ankara City Hospital Bilkent (other)
• Locations: 1 site (Ankara)
• Trial ID: NCT07427368 on ClinicalTrials.gov

What this trial studies

Adults with chronic lateral epicondylitis who have failed first-line conservative care are randomized to receive either extracorporeal shock wave therapy (ESWT) or an ultrasound-guided oxygen-ozone injection once weekly for three weeks. Clinical outcomes (pain and function) and tendon structure on ultrasound are measured to compare the two approaches. ESWT is intended to stimulate tissue repair and modulate pain pathways, while ozone injections are proposed to reduce inflammation and improve local oxygenation and fibroblast activity. The trial targets treatment-resistant cases to identify minimally invasive alternatives to surgery.

Who should consider this trial

Good fit: Adults aged 18–65 with lateral epicondylitis lasting more than three months who have not responded to standard conservative treatments and who have no recent steroid injections or other elbow pathology.

Not a fit: People with acute elbow symptoms, other elbow conditions, prior elbow surgery, systemic inflammatory disease, or a corticosteroid injection within the past six months are unlikely to benefit from these specific interventions.

Why it matters

Potential benefit: If successful, one of these treatments could offer a safer, minimally invasive option that reduces pain and improves function in people with chronic, treatment‑resistant tennis elbow.

How similar studies have performed: ESWT has moderate supportive evidence for chronic tendinopathies while oxygen-ozone injection data are smaller and mixed, and direct head-to-head comparisons are limited.

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.

Where this trial is running

Ankara

• Ankara Bilkent City Hospital — Ankara, Turkey (Türkiye) (RECRUITING)

Study contacts

• Principal investigator: Berke Aras, Medical Doctor — Ankara City Hospital Bilkent
• Study coordinator: Duygu Elbaşı, Medical Doctor

Conditions: Epicondylitis, Lateral, ozone therapy, ESWT, Extracorporeal Shockwave Therapy, tennis elbow, Oxygen-Ozone Therapy, lateral epiconylitis