Musculoskeletal Pain
Conditions
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.
Interventions
DEVICEErchonia 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.
Sponsors
Erchonia Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erchonia EVRL 635 nanometers (nm) and 405 nm dual-diode laser application
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. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Erchonia EVRL |
|---|---|
| Age, Continuous | 54.07 years STANDARD_DEVIATION 14.31 |
| Duration of Neck and Shoulder Pain | 76.58 months STANDARD_DEVIATION 110.82 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 38 Participants |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 44 |
| other Total, other adverse events | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
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.
Time frame: one day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erchonia EVRL | Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) | 75 percentage of subjects |