Clinical trial NCT03941912: The Effect of Low Level Laser Therapy on Neck and Shoulder Pain
Official title: An Evaluation of the Erchonia EVRL on Neck and Shoulder Pain of Musculoskeletal Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Lead sponsor: Erchonia Corporation
Sponsor class: INDUSTRY
First posted: 2019-05-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Largo
country: United States
facility: Comey Chiropractic Clinic
state: Florida
city: White Plains
country: United States
facility: New York ChiroCare
state: New York
Study officials:
affiliation: Test Site
name: Robert Silverman, DC
role: PRINCIPAL_INVESTIGATOR
References: