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.
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).
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.
Parallel
ESWT Device
DeviceApplication 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
Other interventionInjection 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.
Visual Analog Scale (VAS)
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)
Functional disability was assessed using the PRTEE questionnaire. The total score ranges from 0 (no disability) to 100 (significant functional disability).
Grip Strength
Grip strength was measured using a hand-held dynamometer. Measurements were recorded in kilograms
Ultrasonographic Evaluation (Common Extensor Tendon Thickness and Spur Presence)
Ultrasonographic assessment included two parameters: 1) The thickness of the common extensor tendon (CET) measured in millimeters (mm) in the longitudinal plane, and 2) The presence or absence of bony spurs at the lateral epicondyle.
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