Musculoskeletal PainNCT03941912

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

A study testing Erchonia EVRL in people with Musculoskeletal Pain, run by Erchonia Corporation at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Musculoskeletal Pain
What is being tested?: Erchonia EVRL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 2 sitesUnited States
Study dates: 16 Apr 2018to 10 Mar 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

Official title: 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.

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: Musculoskeletal Pain
Being tested: Erchonia EVRL
Medical subject headings: Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Erchonia EVRLDevice
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.

Study groups in NCT03941912
Study group	Role	What they receive
Erchonia EVRL	Experimental	635 nanometers (nm) and 405 nm dual-diode laser application Receives: Device: Erchonia EVRL

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: one day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Apr 201810 Mar 2019

First posted8 May 2019
Study start16 Apr 2018
Primary completion10 Mar 2019
Study completion10 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03941912
Sponsor's protocol ID: EVRL
Status last verified: Oct 2021
First submitted: 6 May 2019
Last updated: 14 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Musculoskeletal Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of the Erchonia EVRL on Neck and Shoulder Pain of Musculoskeletal Origin
ClinicalTrials.gov ID: NCT03941912
Acronym / sponsor ID: EVRL
Conditions: Musculoskeletal Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Erchonia CorporationIndustry (pharma, biotech, devices)
Study start: 16 Apr 2018 (actual)
Primary completion: 10 Mar 2019 (actual)
Study completion: 10 Mar 2019 (actual)
First posted: 8 May 2019 (actual)
Results: Posted 14 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Erchonia EVRL	Experimental	Device: Erchonia EVRL635 nanometers (nm) and 405 nm dual-diode laser application

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Erchonia EVRLSingle 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.	Device	Erchonia EVRL

Primary outcome

Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
Time frame: one day
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.

Results and safety

Results posted to the registry on 14 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Erchonia EVRL	44	44

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

Time frame: one day. Number. Unit: percentage of subjects

Measure	Erchonia EVRL n = 44
Value	75

Adverse events

Time frame: 48 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erchonia EVRL	0 of 44 (0%)	0 of 44 (0%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Musculoskeletal Pain

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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RecruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Silverman, DC principal investigator

Test Site

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Erchonia EVRL in people with Musculoskeletal Pain, run by Erchonia Corporation at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) (time frame: one day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03941912.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.