Completed

A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia ML Scanner (MLS) on Low Back Pain Clinical Study

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What is being tested

Erchonia MLS

+ Placebo Laser

Device
Who is being recruted

Back Pain+3

+ Neurologic Manifestations

+ Pain

Over 18 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorErchonia Corporation
Last updated: February 2, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

Back pain is a common musculoskeletal disorder affecting 80% of people at some point in their lives. It is the second most common neurological ailment in the United States, second only to headache, and it is the most common cause of job-related disability and a leading contributor to missed work. Around $50 billion is spent in the U.S. each year to treat low back pain. Men and women are equally affected, with the most common age affected being between 30 and 50 years. Most low back pain stems from benign musculoskeletal problems, referred to as non-specific low back pain, which is the etiology being evaluated in this study. It is caused by lumbar sprain or strain a stretch injury to the ligaments, tendons, and/or muscles of the low back. Current mainstream treatment approaches for low back pain due to lumbar sprain strain focus on reducing pain and inflammation, including rest; oral and topical over-the-counter and prescription medications; local heat applications; massage and exercise. Alternative treatment options include acupuncture; chiropractic manipulation; biofeedback; traction; transcutaneous electrical nerve stimulation (TENS); and ultrasound. Surgical procedures are also a treatment option for low back pain, and although the outcomes are often poor and do not last, back surgery remains the 3rd most common form of surgery in the United States, with about 300,000 back surgeries performed annually. Low Level Laser Therapy (LLLT) communicates information to the receptors on the membrane of the cell and mitochondrion (the enzymatic engine of the cell). This energetic information reaches the cell's DNA, which directly controls cell function. When the cells receive better information, they work better, as do the tissues they comprise, like bones, cartilage, tendons, ligaments, etc. In this way, LLLT promotes the healing and regeneration of damaged tissues, having both local effects on tissue function and also systemic effects carried throughout the body by the blood and acupuncture meridians. The key basic physiological effects of low level laser light include increased cell membrane polarization and permeability; Adenosine-5-triphosphate (ATP) production and respiratory chain activity; enzyme activity; collagen and epithelial production; capillary formation; macrophage (immune) activity; analgesic effects due to elevated endorphin production, electrolytic nerve blockage, and improved blood and lymph flow; anti-inflammatory effect due to improved circulation and accelerated tissue regeneration; and increased production of antioxidants. Of additional benefit is that light energy from low level lasers will only be absorbed by cells and tissues that are not functioning normally and has no effect on healthy cells. Therefore, low level laser therapy has the potential benefit of providing an effective means of reducing low back pain that is simple, quick, non-invasive and side-effect free.

Principal SponsorErchonia Corporation
Last updated: February 2, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

62 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Back PainNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsLow Back Pain

Criteria

8 inclusion criteria required to participate
Degree of Pain rating on the visual analog scale (VAS) is 40 or greater

Diagnosis based on review of patient history, physical examination, medication use history and review of prior medical records

Low back pain is episodic chronic, having occurred and recurred over regular or irregular intervals of time over at least the last 3 months

Low back pain is of musculoskeletal origin stemming from benign musculoskeletal problems wherein the etiology is lumbar sprain or strain

Show More Criteria

22 exclusion criteria prevent from participating
Active infection, wound, other external trauma to the treatment area

Botulinum toxin injection for chronic low back pain within 4 months of study onset

Cancer or cancer treatment in the past 6 months

Congenital deformity of spine

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
The Erchonia® MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light.

Group II

Placebo
The Placebo Laser has the same appearance as the Erchonia MLS but does not emit any therapeutic light.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

South Mountain Chiropractic Center

Chandler, United StatesOpen South Mountain Chiropractic Center in Google Maps

Mark B. Burdorf DC

Scottsdale, United States
Completed2 Study Centers