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

NCT03941912 | Completed Results FDA Device

• 1 other identifier: EVRL
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Erchonia EVRL

EXPERIMENTAL

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

Device: Erchonia EVRL

Interventions

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.

Erchonia EVRL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (2)

Comey Chiropractic Clinic

Largo, Florida, 33771, United States

Location

New York ChiroCare

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Elvira Cawthon
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

6154475150

Study Officials

• Robert Silverman, DC

  Test Site

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: April 16, 2018
• Primary Completion: March 10, 2019
• Study Completion: March 10, 2019
• Last Updated: October 14, 2021
• Results First Posted: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)