The Effect of the Erchonia GVL Low Level Laser Therapy on Neck and Shoulder Pain

Study Overview
=================
Brief Summary
-----------------
This study is to see if applying green and violet low level laser light to the neck and shoulders can help to reduce pain in the neck and shoulders.

Detailed Description
-----------------
It is the goal of this single (active) group study to evaluate the efficacy of the Erchonia® GVL which simultaneously emits both green (520 nano-meter (nm)) and violet (405 nm) diodes, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Official Title
-----------------
An Evaluation of the Effect of the Erchonia® GVL Green and Violet Laser on Neck and Shoulder Pain

Conditions
-----------------
Musculoskeletal Pain

Intervention / Treatment
-----------------
* Device: Erchonia GVL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject presents with one or more of chronic neck or shoulder pain. Subject is diagnosed with of one or more of osteoarthritis, chronic muscle spasms or cervical and thoracic spine sprain strain. Pain is chronic, having persisted for longer than the past 30 days Self-reported Pain rating on the 0-100 Visual Analog Scale (VAS) of 50 or greater. Willing and able to refrain from consuming any over-the-counter and/or prescription medication(s) and/or herbal supplements intended for the relief of pain and/or inflammation, including muscle relaxants throughout the course of study participation. Willing and able to refrain from engaging in any non-study procedure therapies throughout the course of study participation, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture 18 years of age or older Exclusion Criteria: Current active chronic pain disease: such as chronic fatigue syndrome and fibromyalgia Use of analgesics or muscle relaxants within 7 days prior to study procedure administration. Use of systemic corticosteroid therapy (inhaled and topical corticosteroids permitted), narcotics or Botulinum toxin (Botox®) injection in the neck/shoulder region within 30 days prior to study procedure administration. Active cancer or treatment for cancer within the last 6 months. Unstable cardiac disease, such as recent cardiac arrhythmia, congestive heart failure or myocardial infarction. Prior surgery to the neck/shoulder region. Known herniated disc injury. Active infection, would 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 known mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years. Pregnant or breast feeding. Participation in a research study within the past 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erchonia GVL<br>520 nanometers (nm) and 405 nm dual-diode laser application | Device: Erchonia GVL<br>* Single treatment with the Erchonia GVL to the neck and shoulders. The treatment applies 520 nanometers (nm) green diode light and 405 nm violet diode light simultaneously.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) | The Visual Analog Scale (VAS) from one day, baseline to endpoint measurement (following 13-minute treatment administration) is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success criteria is defined as at least 65%±5% (percentage of subjects) meeting the study individual success criteria. | one day |