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Completed

NCT Number: NCT03941912

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Comey Chiropractic Clinic, Largo, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erchonia EVRL

Device

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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Erchonia Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 8, 2019
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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