Status:
COMPLETED
Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Lateral Epicondylitis
Lead Sponsor:
University of Nove de Julho
Collaborating Sponsors:
Multi Radiance Medical
Conditions:
Lateral Epicondylitis
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Lateral epicondylitis (LE) is one of the most frequently encountered lesions affecting the upper extremity and is the most common cause of elbow pain in adults. It occurs on the lateral side of the el...
Detailed Description
To achieve the proposed objective it will be performed a multi-center, randomized, triple-blinded, placebo-controlled trial, with voluntary patients with lateral epicondylitis. Fifty patients will be ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04829734
Start Date
April 12 2021
End Date
September 15 2021
Last Update
August 29 2025
Active Locations (2)
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1
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, Brazil, 01504-001
2
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, Brazil