Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 3:51 AM
Study NCT ID:
NCT07427368
Status:
RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of ESWT and Ultrasound-Guided Ozone Injection in Lateral Epicondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010126', 'term': 'Ozone'}], 'ancestors': [{'id': 'D010100', 'term': 'Oxygen'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, randomized, comparative study designed to evaluate the efficacy of two different treatment modalities in patients with resistant lateral epicondylitis. Participants will be randomly assigned to two parallel groups (ESWT and Ozone) to compare clinical outcomes.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, immediately after treatment completion, and 4 weeks after treatment completion.', 'description': '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.'}, {'measure': 'Patient-Rated Tennis Elbow Evaluation (PRTEE)', 'timeFrame': 'Baseline, immediately after treatment completion, and 4 weeks after treatment completion.', 'description': 'Functional disability was assessed using the PRTEE questionnaire. The total score ranges from 0 (no disability) to 100 (significant functional disability).'}], 'secondaryOutcomes': [{'measure': 'Grip Strength', 'timeFrame': 'Baseline, immediately after treatment completion, and 4 weeks after treatment completion.', 'description': 'Grip strength was measured using a hand-held dynamometer. Measurements were recorded in kilograms'}, {'measure': 'Ultrasonographic Evaluation (Common Extensor Tendon Thickness and Spur Presence)', 'timeFrame': 'Baseline, immediately after treatment completion, and 4 weeks after treatment completion', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ozone therapy', 'ESWT', 'Extracorporeal Shockwave Therapy', 'tennis elbow', 'Oxygen-Ozone Therapy', 'lateral epiconylitis'], 'conditions': ['Epicondylitis, Lateral']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nParticipants 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.\n\nTo 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.', 'detailedDescription': '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.\n\nExtracorporeal 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.\n\nMedical 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.\n\nAlthough 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: Male or female patients between 18 and 65 years of age.\n* 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).\n* Symptom Duration: Presence of symptoms for more than 3 months (resistant cases).\n* Treatment Failure: Lack of response to first-line conservative treatments (e.g., analgesics, exercise, rest, splinting).\n* Radiographic Confirmation: No other pathology detected on direct radiographs of the elbow.\n* Injection History: No corticosteroid injection to the affected elbow within the last 6 months.\n* Consent: Voluntary participation in the study\n\nExclusion Criteria:\n\n* Elbow Pathology: Presence of elbow problems other than lateral epicondylitis (e.g., loose bodies, rheumatoid nodules).\n* Surgical History: History of previous surgery on the affected elbow joint.\n* Structural Damage: Presence of tendon rupture.\n* Consent: Unwillingness to continue treatment or participate.\n* Spinal Pathology: Cervical root pathology (cervical radiculopathy).\n* Neuropathy: Diagnosed upper extremity entrapment neuropathy.\n* Neurological Status: Presence of neurological impairment or deficits.\n* Recent Injections: History of injection therapy to the elbow within the last 6 months.\n* Recent Therapy: History of physical therapy for the elbow region within the last 6 months.\n* Pregnancy: Pregnant women.\n* Hematological: Presence of coagulation or bleeding disorders.\n* Vascular: Presence of peripheral vasculopathy.\n* Pain Syndromes: Presence of Complex Regional Pain Syndrome (CRPS).\n* Oncology: History of malignancy.\n* Systemic Diseases: Presence of systemic inflammatory or autoimmune disorders (e.g., Rheumatoid Arthritis, SLE).\n* Trauma: History of direct trauma to the elbow.\n* Medication: Current use of medications that may affect pain levels or muscle strength (e.g., muscle relaxants, analgesics, gabapentinoids).\n* Local Infection: Presence of open wounds, infection, or signs of active inflammation in the elbow region.\n* Cooperation: Difficulty in cooperation or cognitive inability to follow instructions.\n* Enzyme Deficiency: Congenital Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency."}, 'identificationModule': {'nctId': 'NCT07427368', 'briefTitle': 'Comparison of ESWT and Ultrasound-Guided Ozone Injection in Lateral Epicondylitis', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparison of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) and Ultrasound-Guided Ozone Injection Therapy in Patients With Resistant Lateral Epicondylitis', 'orgStudyIdInfo': {'id': 'E2-25-11166'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ESWT Group', 'description': 'This group consists of patients diagnosed with lateral epicondylitis resistant to conservative treatment who are randomly allocated to the extracorporeal shock wave therapy arm.', 'interventionNames': ['Device: ESWT Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ozone Injection Group', 'description': 'This group consists of patients diagnosed with lateral epicondylitis resistant to conservative treatment who are randomly allocated to the injection arm.', 'interventionNames': ['Other: ozone injection']}], 'interventions': [{'name': 'ESWT Device', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['ESWT Group']}, {'name': 'ozone injection', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Ozone Injection Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Duygu Elbaşı, Medical Doctor', 'role': 'CONTACT', 'email': 'duyguelbasi@gmail.com', 'phone': '+905544739970'}, {'name': 'Berke Aras, Medical Doctor', 'role': 'CONTACT', 'email': 'drberkearas@gmail.com', 'phone': '+905365851518'}], 'overallOfficials': [{'name': 'Berke Aras, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}