💬In plain words
What the trial is, and whether it could suit you
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 wee
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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