- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04895618
The Effect of the Erchonia GVL Low Level Laser Therapy on Neck and Shoulder Pain
An Evaluation of the Effect of the Erchonia® GVL Green and Violet Laser on Neck and Shoulder Pain
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
West Covina, California, United States, 91790
- Gair Laser Chiropractic
-
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Florida
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Largo, Florida, United States, 33771
- Comey Chiropractic Clinic
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New York
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White Plains, New York, United States, 10605
- New York ChiroCare
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Erchonia GVL
520 nanometers (nm) and 405 nm dual-diode laser application
|
Single treatment with the Erchonia GVL to the neck and shoulders.
The treatment applies 520 nanometers (nm) green diode light and 405 nm violet diode light simultaneously.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
Time Frame: 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. |
one day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GVL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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