Musculoskeletal Pain
Conditions
Brief summary
This study is to see if applying pre-treatment with the Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy can help reduce nociceptive musculoskeletal pain
Detailed description
It is the goal of this single (active) group study to evaluate the efficacy of the pre-treatment with the Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy, is non-inferior to (equivalent to or superior to) the standard Erchonia red laser therapy when applied alone in providing temporary relief of nociceptive musculoskeletal pain
Interventions
DEVICEErchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy
450 nanometers (nm) blue dual-diode laser application followed by 640nm red laser application
Sponsors
Erchonia Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 22 years of age or older * Primary language is English * Subject presents with with one or more of: * chronic neck pain on the right side of the neck and/or the left side of the neck and/or the back of the neck; and/or * chronic shoulder pain on the right shoulder and/or the left shoulder. * Subject is diagnosed with of one or more of the following: * Osteoarthritis: Degenerative Joint Disorder (DJD) * Chronic Muscle Spasms * 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
Exclusion criteria
* Presenting primary pain is located outside or in addition to the region of the neck (right side/left side/back) or the shoulder (right and/or left side) * Etiology of neck/shoulder pain cannot be definitively diagnosed; or has bene diagnosed as being in whole or in part other than that of osteoarthritis, chronic muscle spasms or cervical and thoracic spine sprain strain; or other potentially contributing etiologies cannot be satisfactorily ruled out * Pain is acute: symptoms prevailed for fewer than each of the prior 30 days * 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) | Day 1 | 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
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age, Continuous | 54.18 years STANDARD_DEVIATION 13.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 24 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
None listed