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

NCT ID: NCT03941912

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-16
• Study Completion Date: 2019-03-10

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erchonia EVRL

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

Group Type: EXPERIMENTAL

Erchonia EVRL

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erchonia Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Silverman, DC

Role: PRINCIPAL_INVESTIGATOR

Test Site

Locations

Comey Chiropractic Clinic

Largo, Florida, United States

New York ChiroCare

White Plains, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study Protocol

View Document

Other Identifiers

EVRL

Identifier Type: -

Identifier Source: org_study_id