Status:
COMPLETED
The Effect of the Erchonia GVL Low Level Laser Therapy on Neck and Shoulder Pain
Lead Sponsor:
Erchonia Corporation
Conditions:
Musculoskeletal Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is to see if applying green 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 this single (active) group study to evaluate the efficacy of the Erchonia® GVL which simultaneously emits both green (520 nano-meter (nm)) and violet (405 nm) diodes, for adjunctive ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04895618
Start Date
November 11 2020
End Date
May 20 2022
Last Update
August 21 2023
Active Locations (3)
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1
Gair Laser Chiropractic
West Covina, California, United States, 91790
2
Comey Chiropractic Clinic
Largo, Florida, United States, 33771
3
New York ChiroCare
White Plains, New York, United States, 10605