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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: duyguelbasi@gmail.com
• Phone: +905544739970

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.