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:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT04829734
Eligibility Criteria:
Inclusion Criteria:
* Patients with a history of pain around the lateral epicondyle for at least 1 month;
* Self-reported Degree of Pain rating on the 0-100 VAS pain scale for the lateral epicondyle region is 50 or greater;
* Tenderness localized to the epicondyle and anterodistal region of the epicondyle with palpation;
* 2 of 4 positive results of provocative tests comprising of Maudsley's, Cozen's, Thomsen and Mill's tests;
* Aged between 18 and 50 years;
* Both genders;
* Patients fluent in Portuguese.
Exclusion Criteria:
* hemophilia or any type of blood clotting disorder;
* chronic immune impairment neoplasia;
* cancer or treatment for cancer in the past 6 months, including tumors of the spinal cord;
* diabetes Type 1;
* significant heart conditions including CHF and implantable heart devices such as a pacemaker;
* current, active chronic pain disease: chronic fatigue syndrome, fibromyalgia, endometriosis, inflammatory bowel disease, interstitial cystitis diabetic neuropathic pain;
* neurologic deficits;
* cervical radiculopathy;
* peripheral nerve disease;
* rheumatoid arthritis;
* shoulder disease;
* radial tunnel syndrome;
* previous surgery of the affected upper extremities;
* congenital or acquired bony deformity in the ipsilateral upper extremity;
* bilateral epicondylosis;
* secondary orthopedic problems;
* the initiation of opioid analgesia or corticosteroid or analgesic injection interventions within the previous 6 months;
* local corticosteroids and/or botulinum toxin (Botox®) injection for Lateral Epicondyle pain relief within the prior 30 days;
* medical tx; such as chiropractic care and acupuncture within last 30 days;
* physical therapy intervention on the upper extremity in the previous year;
* active infection, wound, or other external trauma to the areas to be treated with the laser;
* medical, physical, or other contraindications for, or sensitivity to, light therapy;
* serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years;
* pregnant, breast feeding, or planning pregnancy prior to the end of study participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04829734
Study Brief:
Protocol Section:
NCT04829734