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Clinical Trials in Turkey / NCT07427368
Recruiting Not applicable

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

NCT07427368 · tracked via the Priya Life Science Turkey tracker
Sponsor
Ankara City Hospital Bilkent
Phase
Not applicable
Started
2025-06-01
Last updated
2026-02-23

Condition(s) studied

Epicondylitis, Lateral

Investigational drug(s) / intervention(s)

ESWT Deviceozone injection

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.

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Visual Analog Scale (VAS) — 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.
  • Patient-Rated Tennis Elbow Evaluation (PRTEE) — 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).

Trial sites (1)

FacilityCityRegionStatus
Ankara Bilkent City Hospital Ankara Turkey (Türkiye) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07427368 on ClinicalTrials.gov ↗ ← All trials in Turkey