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The Effect of 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 EVRL

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

Comey Chiropractic Clinic
New York ChiroCare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erchonia EVRL

Arm Description

635 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

NCT ID

NCT03941912

First Posted

May 6, 2019

Last Updated

October 13, 2021

Sponsor

Erchonia Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03941912

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

April 16, 2018 (Actual)

Primary Completion Date

March 10, 2019 (Actual)

Study Completion Date

March 10, 2019 (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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

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

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Erchonia EVRL

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Erchonia EVRL

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)

Description

Time Frame

one day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Silverman, DC

Organizational Affiliation

Test Site

Official's Role

Principal Investigator

Facility Information:

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

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

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