Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07427368
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Ankara, Turkey (Türkiye)
Location status: Recruiting
Lateral epicondylitis is a painful and often debilitating tendinopathy affecting the common extensor tendon origin. Although most patients respond to standard conservative management, a substantial proportion progress to a chronic, refractory condition. For these resistant cases, identifying effective and minimally invasive treatment options remains a significant clinical challenge.
Extracorporeal Shock Wave Therapy (ESWT) is a non-invasive modality widely used in the management of chronic tendinopathies. Its proposed therapeutic mechanisms include the induction of controlled microtrauma, stimulation of neoangiogenesis, increased local blood flow, and modulation of pain-related signaling pathways, ultimately promoting tissue regeneration.
Medical ozone therapy has emerged as a potential regenerative injection approach. The local administration of an oxygen-ozone gas mixture into the affected tissue is thought to exert anti-inflammatory effects, enhance tissue oxygenation, and stimulate fibroblast activity, thereby supporting cellular repair processes within degenerated tendon tissue.
Although both modalities demonstrate potential therapeutic benefits, direct comparative evidence regarding their effectiveness in chronic, treatment-resistant lateral epicondylitis remains limited. This study aims to compare the clinical and structural outcomes associated with these two treatment approaches. By evaluating both symptom improvement and objective ultrasonographic tendon changes, this trial seeks to provide evidence to inform optimal treatment strategies for chronic cases.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, immediately after treatment completion, and 4 weeks after treatment completion.
Grip strength was measured using a hand-held dynamometer. Measurements were recorded in kilograms
Time frame: Baseline, immediately after treatment completion, and 4 weeks after treatment completion
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.
Contact information is provided by the study sponsor or research team.
Berke Aras, Medical Doctor
CONTACT
Duygu Elbaşı, Medical Doctor
CONTACT
Ankara City Hospital Bilkent
Other
Comparison of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) and Ultrasound-Guided Ozone Injection Therapy in Patients With Resistant Lateral Epicondylitis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06587412
Arm Injuries, Elbow Injuries
Alcalá de Henares, Madrid, Spain
View Trial DetailsNCT07558564
Achilles Tendinopathy (AT), Arm Injuries
A Coruña, Spain
View Trial DetailsNCT07717203
Arm Injuries, Elbow Injuries
View Trial DetailsNCT07661615
Arm Injuries, Elbow Arthroscopy Surgery
Lyon, France
View Trial Details