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

An Evaluation of the Erchonia EVRL on Neck and Shoulder Pain of Musculoskeletal Origin

This study is to see if applying red and violet low level laser light to the neck and shoulders can help to reduce pain in the neck and shoulders.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain
• Intervention / Treatment: Device: Erchonia EVRL

Detailed Description

It is the goal of the current study to demonstrate non-inferiority in efficacy of the Erchonia® EVRL when used in simultaneous dual diode mode (both the red (640 nano-meter (nm)) and violet (405 nm) diodes activated simultaneously) compared to its use with the red diode only activated, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Largo, Florida, United States, 33771
      • Comey Chiropractic Clinic
  • New York
    • White Plains, New York, United States, 10605
      • New York ChiroCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erchonia EVRL; 635 nanometers (nm) and 405 nm dual-diode laser application	Device: Erchonia EVRL; Single treatment with the Erchonia EVRL to the neck and shoulders. The treatment applies 635 nanometers (nm) red diode light and 405 nm violet diode light simultaneously.

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

Collaborators and Investigators

• Sponsor: Erchonia Corporation
• Investigators: Principal Investigator: Robert Silverman, DC, Test Site

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): March 10, 2019
• Study Completion (Actual): March 10, 2019

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Arthralgia; Shoulder Pain; Musculoskeletal Pain
• Other Study ID Numbers: EVRL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No