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

Musculoskeletal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03941912
• Other study ID #: EVRL
• Status: Completed
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: March 10, 2019

Study information

• Verified date: October 2021
• Source: Erchonia Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 10, 2019
• Est. primary completion date: March 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Pain
• Shoulder Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Comey Chiropractic Clinic	Largo	Florida
United States	New York ChiroCare	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Erchonia Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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