Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07427368
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07427368
Study Brief:
Protocol Section:
NCT07427368