Effects of Multi Radiance Medical® Super Pulsed Laser on Chronic Knee Pain

Inclusion Criteria:

• Signed consent form.
• Aged between 18 and 50 years, inclusive.
• Any gender.
• Subject is fluent in Portuguese.
• The volunteers' presenting primary (dominant) pain is in the region of the right orleft knee only. i.e., it is unilateral.
• Self-reported degree of pain rating on the 0-100 VAS pain scale for the target knee is 50 or greater.
• Self-reported degree of pain rating on the 0-100 VAS pain scale for the non-targetknee is less than 20.
• Knee pain is episodic chronic, defined as having occurred and recurred over regular orirregular periods or intervals of time, persisting over at least the last 3 months.
• Volunteers' knee pain is of benign musculoskeletal origin wherein the etiology istendinopathies, synovitis, bursitis, strain, and sprain, of traumatic or non-traumaticorigin, as determined by the principal investigator based on any one or combination ofthe following:
• Prior diagnosis by a qualified licensed medical professional current within the last 2years evidenced through source documentation.
• Previous Records Review, such as x-ray, MRI, CT scans, etc., where available, thatindicate muscle or ligament injury and the absence of Degenerative Joint Disorder (DJD).
• Medical history consistent with one of the etiologies of knee pain falling within thescope of this study.
• Physical examination of the knee that yields one or both of the following findings:Increased pain upon range of motion and/or increased pain and weakness upon kneeextension, knee flexion, or gait.
• Subject is willing and able to maintain his or her individualized pain regimen asdetermined by the study principal investigator at baseline as needed to manage anyknee pain that may arise throughout the course of study duration, whilst refrainingfrom consuming other over the counter and/or prescription medication(s) and/or herbalsupplements intended for the relief of pain and/or inflammation, and/or partaking inother treatments/therapies.

Exclusion Criteria: A volunteer who satisfies any one or more of the following criteria will be excluded fromstudy participation:

• The volunteers' presenting primary pain is located outside or in addition to the knee.
• The volunteers' presenting primary pain is bilateral, i.e., equally dominant in theright and left knees.
• Self-reported degree of pain rating on the 0-100 VAS pain scale for the target knee isless than 50.
• Self-reported degree of pain rating on the 0-100 VAS pain scale for the non-targetknee is 20 or greater.
• Knee pain is acute, defined as having persisted less than half the time over less thanthe last 3 months.
• Knee pain is not episodic, such that it has either been continually present withoutrespite over the past 3 months and/or there has not been recurrent episodes within thepast 3 months.
• Volunteers' knee pain is of other than, or in addition to, benign musculoskeletalorigin wherein the etiology is tendinopathies, synovitis, bursitis, strains, andsprains from traumatic or non-traumatic origin, and/or the etiology of the subject'sknee pain cannot be satisfactorily ruled out.
• Prior surgical intervention to the target knee that in the opinion of the principalinvestigator may affect the study treatment and or outcomes assessment.
• Neurologic deficits that in the opinion of the principal investigator may affect thestudy treatment and or outcomes assessment.
• Peripheral nerve disease.
• Rheumatoid arthritis.
• Hip or ankle disease.
• Congenital or acquired bony deformity in the ipsilateral lower extremity.
• Secondary orthopedic problems that in the opinion of the principal investigator mayaffect the study treatment and or outcomes assessment.
• Local corticosteroids and/or botulinum toxin (Botox®) injection for knee pain reliefwithin 30 days prior to study enrollment.
• Treatments such as chiropractic care, and acupuncture within 30 days prior to studyenrollment.
• Current, active chronic pain disease, such as chronic fatigue syndrome, fibromyalgia,endometriosis, inflammatory bowel disease, interstitial cystitis diabetic neuropathicpain,
• Current cancer or treatment for cancer in the past 6 months.
• Significant heart conditions including chronic heart failure (CHF) and implantableheart devices such as a pacemaker.
• Active infection, wound, or other external trauma to the areas to be treated with thePBMT.
• Medical, physical, or other contraindications for, or sensitivity to, light therapy.
• Pregnant, breast feeding, or planning pregnancy prior to the end of studyparticipation.
• Female subject of childbearing age who is unwilling to engage in effective medicalcontraceptive use while sexually active during the study procedure administrationphase.
• Serious mental health illness such as dementia or schizophrenia; psychiatrichospitalization in past two years.
• Developmental disability or cognitive impairment that in the opinion of the principalinvestigator would preclude adequate comprehension of the informed consent form and/orability to record the necessary study measurements.
• Any other medical condition or medication use that in the opinion of the principalinvestigator may affect the study treatment and or outcomes assessment.