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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Ankara Bilkent City Hospital
RECRUITING
Ankara
Contact Information
Primary
Duygu Elbaşı, Medical Doctor
duyguelbasi@gmail.com
+905544739970
Backup
Berke Aras, Medical Doctor
drberkearas@gmail.com
+905365851518
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-03-03
Participants
Target number of participants: 50
Treatments
Active_comparator: ESWT Group
This group consists of patients diagnosed with lateral epicondylitis resistant to conservative treatment who are randomly allocated to the extracorporeal shock wave therapy arm.
Active_comparator: Ozone Injection Group
This group consists of patients diagnosed with lateral epicondylitis resistant to conservative treatment who are randomly allocated to the injection arm.
Related Therapeutic Areas
Sponsors
Leads: Ankara City Hospital Bilkent

This content was sourced from clinicaltrials.gov