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

Primary Purpose

Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erchonia GVL
Sponsored by
Erchonia Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gair Laser Chiropractic
  • Comey Chiropractic Clinic
  • New York ChiroCare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erchonia GVL

Arm Description

520 nanometers (nm) and 405 nm dual-diode laser application

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 17, 2021
Last Updated
August 17, 2023
Sponsor
Erchonia Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04895618
Brief Title
The Effect of the Erchonia GVL Low Level Laser Therapy on Neck and Shoulder Pain
Official Title
An Evaluation of the Effect of the Erchonia® GVL Green and Violet Laser on Neck and Shoulder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
May 18, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erchonia Corporation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erchonia GVL
Arm Type
Experimental
Arm Description
520 nanometers (nm) and 405 nm dual-diode laser application
Intervention Type
Device
Intervention Name(s)
Erchonia GVL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
Description
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.
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Gair Laser Chiropractic
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Comey Chiropractic Clinic
City
Largo
State/Province
Florida
ZIP/Postal Code
33771
Country
United States
Facility Name
New York ChiroCare
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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