CompletedNCT03941912Updated Oct 14, 2021Results posted

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

An interventional study of Erchonia EVRL in Musculoskeletal Pain, sponsored by Erchonia Corporation. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-14.

Sponsored by Erchonia Corporation · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 1 year after the study started (first participant enrolled Apr 2018, registered May 2019).

Phase: Not applicable
Study type: Interventional
Enrollment: 44
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Musculoskeletal Pain

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In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 44 is below the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Erchonia Corporation is the lead sponsor of 48 studies on the registry; 2 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 44 participants (actual)

Study arms

Experimental
Erchonia EVRL
635 nanometers (nm) and 405 nm dual-diode laser application
Device: Erchonia EVRL

Interventions

DeviceErchonia 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 researchers measure

Primary outcomes

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.
Time frame: one day

Results

Posted Oct 14, 2021

Participant flow

Participant flow — Overall Study
Milestone	Erchonia EVRL
Started	44
Completed	44
Not completed	0

Outcome measures

PrimaryPercentage 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.

Time frame:: one day
Reported as:: Number · percentage of subjects

Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
percentage of subjects	Erchonia EVRL
Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)	75

Adverse events

Collected over 48 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Erchonia EVRL	0/44 (0%)	0/44 (0%)	0/44 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Erchonia EVRL
Mean	54.07 ± 14.31

Sex: Female, Male
Sex: Female, Male(Participants)	Erchonia EVRL
Female	27
Male	17

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Erchonia EVRL
American Indian or Alaska Native	0
Asian	2
Native Hawaiian or Other Pacific Islander	0
Black or African American	1
White	38
More than one race	0
Unknown or Not Reported	3

Region of Enrollment
Region of Enrollment(participants)	Erchonia EVRL
United States	44

Duration of Neck and Shoulder Pain
Duration of Neck and Shoulder Pain(months)	Erchonia EVRL
Mean	76.58 ± 110.82

Study locations

2 sites

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

References and documents

Study documents

Protocol, analysis plan and consent form · Mar 21, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03941912
Lead sponsor: Erchonia Corporation
Responsible party: Sponsor
First posted: May 8, 2019
Start date: Apr 16, 2018
Primary completion: Mar 10, 2019
Completion: Mar 10, 2019
Results posted: Oct 14, 2021
Last update: Oct 14, 2021

Study contacts

Robert Silverman, DC

principal investigator · Test Site

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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