An Overview of Photobiomodulation (PBM) Therapy
The human body uses light-induced photochemical reactions on a daily basis. From the photosensitive cells in our eyes to the light-reliant vitamin D synthesis process in our skin, our bodies rely on and can use light in numerous ways. It stands to reason then, that many cells in the human body may react to light. So how does light affect cells in the body, and how can it be used for the benefit of human health? That is the question behind the treatment method called Photobiomodulation Therapy (PBMT), commonly known as Low-Level Laser Therapy (LLLT) or Cold Laser Therapy (though within the PBMT sector it is important to distinguish between Low-Level Laser Therapy and High-Level Laser Therapy for the reasons explained below).
What Is Photobiomodulation Therapy (PBMT)?
Discovered in 1967 by Endre Mester, Photobiomodulation Therapy involves placing a low-power laser near to or on the skin, allowing the photons to move through the tissue and interact with cells in the body.
A Low-Level Laser can be roughly categorised as having a power output of <500mW, classified as either ‘Class IIIB Lasers’, ‘Class IIIR Lasers’, or ‘Class II Lasers’ by the FDA (i.e. low risk of hazard). Various dosimetry parameters (e.g. wavelength, fluence, power density) are used depending on the device / treatment type.
What Are the Benefits?
- Pain Management
Pain is the most common reason that people see doctors, with roughly one in ten people affected by chronic pain each year. Photobiomodulation Therapy has been explored in clinical studies as a way of decreasing several types of pain, including:
• Orthopaedic pain: PBMT has pain-reducing effects on musculoskeletal conditions, including patients recovering from sprains, whiplash, muscular pain, cervical or lumbar radiculopathy, tendinitis, and carpal tunnel syndrome. It has also shown positive effects on individuals with chronic conditions like arthritis and osteoarthritis, and in treating post-surgical dental pain.
• Neuropathic pain: Neuropathic pain conditions can be treated effectively with PBMT, including various types of neuralgia and diabetic neuropathy.
Although we still have a lot to learn about the effects of light energy on different types of cells, the leading theory is that Photobiomodulation Therapy generates therapeutic effects through stimulating and enhancing specific biochemical processes.
More specifically, utilising the first law in photochemistry (Grotthuss-Draper law), laser energy is transferred to cytochrome c oxidase (CcO) – a respiratory energy-transducing enzyme which is involved in the electron transport chain in mitochondria. This energy transfer causes photodissociation of inhibitory nitric oxide from CcO, leading to an enhancement of enzyme activity, electron transport, mitochondrial respiration, and adenosine triphosphate (ATP) production. Consequently, by altering the cellular redox state, PBMT induces the activation of numerous intracellular signalling pathways, and alters the affinity of transcription factors concerned with cell proliferation, survival, repair, and regeneration.
- Fat Removal
Multiple studies have been conducted to determine whether Photobiomodulation Therapy can be used for fat reduction, with positive results. One review found that PBMT is effective at reducing fat and cellulite and improves blood lipid profiles with little to no side effects.
The current theory as to why PBMT is effective in this area is that it creates transient pores in adipocytes, allowing lipids to leak out. The fatty liquids are then naturally flushed out through the lymphatic system.
The result is that the fat cells shrink instead of being killed. When this happens, the shrunken fat cells begin to act and function like healthy lean cells, releasing the correct messages to the brain and creating a communication effect throughout the fat organ, causing other fat cells to release their content and return their hormone responses to the positive.
Procedures that have been popular in the past (such as fat freezing) focus on the elimination of fat cells, but recent research has shown this approach to be less effective, and in the worst-case scenario, providing counterproductive results.
- Fungal Nail Treatment
The unsightly onychomycosis is a fungal infection of the nails that causes discoloration, thickening, and separation from the nail bed. It is a very common condition, occurring in approximately 10% of the general population, with those above 60 being especially affected (20% – 50%).
The most common treatments for fungal nail infections include antifungal nail creams (largely ineffective) and prescription antifungal medications taken orally (can cause side-effects). Photobiomodulation Therapy has been shown to effectively treat nail fungus with little to no side-effects.
Although the exact mechanism of action is currently unclear, it is theorised that PBMT triggers a photochemical reaction, producing Reactive Oxygen Species (ROS) which is converted to Hydrogen Peroxide – a natural antiseptic that kills onychomycosis. In addition, PBMT induces the production of Adenosine Triphosphate (ATP) which is converted to Nitric Oxide, aiding the natural immune response in fighting the infection.
What Is the Difference Between Types of Photobiomodulation Therapy Devices?
To understand the difference between the various types of Photobiomodulation Therapy devices, it is first important to distinguish between High-Level Laser Therapy (HLLT) and Low-Level Laser Therapy (LLLT):
- HLLT devices are classified as ‘Class IV Lasers’ by the FDA in virtue of having a power output that’s greater than 500mW (i.e. high risk of hazard).
- LLLT devices are classified as either ‘Class IIIB Lasers’, ‘Class IIIR Lasers’, or ‘Class II Lasers’ in virtue of having a power output of 5-500mW, 1-5mW, or <1mW respectively (i.e. lower risk of hazard).
The vast majority of HLLT devices have longer near-infrared (NIR) wavelengths – there is a common misconception, often propagated by the manufacturers of such devices, that high power with longer wavelengths results in:
- Deeper penetration, allowing for the treatment of a wider range of conditions.
- More efficacious results (due to the delivery of more energy into the cells).
This however, is not correct for the following well-documented reasons:
- Due to the high absorption rate of laser light by water at wavelengths greater than 950nm, most of the energy produced at this wavelength (or above) is absorbed before penetrating the dermis.
- The key principle behind PBMT is to generate therapeutic effects by stimulating and enhancing specific biochemical processes within cells. However, there is an optimal ‘dose’ of laser energy (typically 2-4 joules / cm²) required for stimulating and enhancing the desired biochemical processes – HLLT devices exceed this optimal level.
Put simply, HLLT devices deliver too much energy at inefficient wavelengths, resulting in a lack of efficacy and increased costs.
To add to this, the high outputs used by such devices produce painful heat sensations, further limiting their scope of treatment.
In essence, HLLT devices should only be used for laser surgery and tissue ablation – the high outputs are effective for cell destruction, but are not suited for therapeutic purposes, contrary to the claims of Class IV manufacturers.
Low-Level Laser Therapy devices, on the other hand, aim to deliver energy via low output, short wavelength beams of light. The general theory is that this approach transfers the optimal amount of energy for stimulating and enhancing cell function, while not damaging cells or producing painful heat sensations.
Within the LLLT sector however, some of the higher output devices still generate heat / pain. Furthermore, many devices are advertised as ‘lasers’, when in fact they are Light Emitting Diodes (LEDs) or Superluminescent Diodes (SLDs). In contrast to LEDs or SLDs, ‘true’ lasers generate monochromatic, collimated, and coherent beams of light. These three properties of true lasers make them the most effective and efficient devices within the Photobiomodulation Therapy sector.
To separate Erchonia® from such technologies, and from HLLT more generally, we say that Erchonia® lasers are ‘non-thermal, true lasers’. That is, our lasers do not produce any heat or painful sensations, and are monochromatic, collimated, and coherent (to learn more, please read Class 4 Lasers, Class 3 Lasers, and Class 2 Lasers).
Common FAQs About Erchonia® PBM Therapy Devices
What Is the Scientific Evidence Behind Erchonia® Lasers?
All studies carried out to obtain FDA-clearance are double blind, randomised, placebo-controlled, and multi-site – the most credible research of all Photobiomodulation Therapy devices on the market today.
The following list shows the clinical trials and an outline of their progress. As a company, to protect our intellectual assets, not all clinical trials we are involved with are made public so as to maintain our competitive advantage. As such, not all clinical trials are listed below.
Please note: There are hundreds of clinical studies confirming the effectiveness of Photobiomodulation Therapy, and every year there are many new publications. Below is a list of Erchonia-specific studies for FDA-clearance.
1) Chronic Neck and Shoulder Pain / Low Level Laser — 2000 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
- First study done in support of 510(k) submission, second study requested by FDA.
2) Chronic Neck and Shoulder Pain / Low Level Laser — 2001 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
3) Low Level Laser Light Therapy as an Aid to Liposuction and Reduction of Pain Associated With Surgery — 2004 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
4) Acne Vulgaris — Dermatological Conditions / Low Level Laser — 2005 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
- FDA clearance – K050672
5) Pain Associated With Breast Augmentation Surgery / Low Level Laser — 2007 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
6) Non-Invasive Fat Reduction and Body Contouring – Laser Scanner Waist, Hips, and Thighs — 2009 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
7) Equine Wound Healing – 2011 — Sponsor, Case Study.
- Study completed from Nov. 2010-March 2011.
- Monitored by Hank Jann, DVM, MS, DACVS from Oklahoma State University.
8) Equine Wound Healing – 2011 — Sponsor, placebo controlled, clinical study.
- Study completed from Feb. 2011-April 2011.
- Monitored by Hank Jann, DVM, MS, DAVCS from Oklahoma State University.
9) Arm Circumference Reduction of the Upper Arms — 2011 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
- Study results used to obtain FDA clearance – K120257
- Study submitted to be published 2012.
- To view NIH clinical trial records, click here.
10) Appearance of Cellulite (Verju Laser System) — 2012 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
- FDA clearance – K130922
- Study submitted to be published 2013.
- To view NIH clinical trial records, click here.
11) Non-Invasive Body Contouring Using GLS Laser – 532 nm (Green) Trade Name Verju — 2012 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
- FDA clearance – K123237
- Study submitted to be published 2013.
- To view NIH clinical trial records, click here.
12) Adjunct to Chronic Heel Pain Arising from Plantar Fasciitis Using the Erchonia FX635 Laser — 2012 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
- FDA clearance – K132940
- Study results published in the American Orthopaedic Foot & Ankle Society April 2014
- To view NIH clinical trial records, click here.
13) Non-Invasive Dermatological Aesthetic Treatment for Reduction of Circumference of Hips, Waist and Upper Abdomen When Applied to Individuals with a Body Mass Index (BMI) Between 30 kg/m2 and 40 kg/m2 — 2013 – Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
14) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of Hips, Waist and Thighs (Zerona-Z6 OTC) — 2012 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
15) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of Hips, Waist, Thighs and Upper Abdomen — 6 Week Treatment Protocol (Zerona-Z6) — 2014 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
16) Erchonia EVRL (EVRL) – 2016
a. while using the red diode, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
- FDA clearance – K152196
17) Temporary Increase of Clear Nail in Patients With Onychomycosis (e.g., Dermatophytes Trichophyton Rubrum and T. mentagrophytes, and/or Yeasts Candida Albicans, etc.) (Lunula Laser ) — 2016 — Sponsor and monitor, IRB approved, blind, placebo controlled, clinical study.
18) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Body Circumference (Zerona-Z6) — 2016.
- FDA clearance – K162578
19) Market Clearance to Treat Chronic Low Back Pain (FX 635) — 2018 — Placebo-controlled, randomized, double-blind, parallel-group, multi-center clinical study.
20) Market Clearance for Relief of Chronic Musculoskeletal Pain (FX 635) — 2019 — A collection of placebo-controlled, randomized, double-blind, parallel-group, multi-center clinical studies.
- FDA clearance – K190572
21) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Body Circumference in Individuals With a Body Mass Index (BMI) of up to 40 kg / m² — 2019 — The data used to get this approval combined all previous data Erchonia® had on 20-40 BMI patients in the green laser studies above.
What Is the Difference Between Erchonia® and Other Technologies in This Market?
The efficacy of Erchonia® lasers has been scientifically proven with double blind, randomised, placebo-controlled, and multi-site studies. Many competing companies advertise their products as ‘clinically proven’, guaranteeing ‘instant results’. However, these claims are often not backed by comprehensive clinical evidence.
Several companies have FDA-clearance within the Photobiomodulation Therapy sector, however, in most cases the intended use / indications of their products are quite limiting or not relevant to the marketed applications. Furthermore, these FDA-clearances are often obtained without any scientific research.
We always recommend that you ask for details of the FDA-clearances and make an informed decision. Pay particular attention to the scope of the clearance, whether it involved clinical studies, how many patients participated, were the studies placebo controlled, double blind, and randomised, how many peer reviewed published articles they have, and what the adverse reactions / side effects were – we would be happy to provide this information for you.
What Conditions Can Erchonia® Pain Relief Lasers Help With?
Erchonia® pain relief lasers can help a wide variety of patients, including: Orthopaedic pain – sprains, whiplash, muscular pain, cervical or lumbar radiculopathy, tendinitis, and carpal tunnel syndrome. Our devices have also shown positive effects on individuals with chronic conditions like arthritis and osteoarthritis, and in treating post-surgical pain; Neuropathic pain, including various types of neuralgia and diabetic neuropathy; Pain management for athletes recovering from training or injuries.
What Areas Do Erchonia® Fat Removal Lasers Treat?
Erchonia® lasers for fat removal treat overall body circumference while also allowing your clients to target stubborn areas of fat and cellulite.
Most people who undergo the treatments focus on their midriff and thighs, but the device can also target any area of subcutaneous fat, including bra strap, upper arms, jowls, knees, and more.
Are There Any Conditions Which Would Prevent Patients From Receiving the Treatments?
There are no code regulated contraindications, however, since there are no long-term evaluations on certain conditions, we do not recommend using Erchonia® non-thermal lasers on pregnant women, clients with a pacemaker, or clients with photosensitive epilepsy. We also do no recommend using our devices over an area of known cancer.
Will Erchonia® Lasers Cause Pain or Burning?
Erchonia® are true non-thermal Photobiomodulation Therapy devices and cause no pain or health risks.
What Do Erchonia® Lasers Treat and How Are They Used?
Erchonia® lasers are used in many areas, such as 360-degree fat loss, body sculpting, cellulite reduction, pain management, pre / postsurgical healing, pre / rehabilitation, nail and skin pathologies (e.g. nail fungus and acne), and more.
Not only do our lasers treat specifics, but they also empower the body to function efficiently due to the beneficial effects they have on our cells.
Why Choose Erchonia®?
With over 25 years of experience, 16,000+ devices in the market, and 20 FDA-clearances, Erchonia® Corporation are world leaders in medical-grade Photobiomodulation Therapy technology.
Erchonia® own 20 of the 23 FDA-clearances given to Photobiomodulation Therapy devices, and the efficacy of our machines has been proven by multiple (level 1) double blind, randomised, placebo-controlled, and multi-site clinical studies – the most credible research in the market today.
We are dedicated to producing safe, effective solutions designed for physicians, chiropractors, physical therapists, podiatrists, osteopaths, aesthetics clinics, veterinarians, and many other types of medical / health professionals.
All Erchonia® laser systems are cut from raw materials, and all of our products go through a rigorous quality control process before delivery to our customers around the world. As a company, we are 85% self-reliant in all facets of our organisation, and all of our products are FDA, ISO, OSHA, and MDSAP compliant.
The Erchonia® mission statement is simply “Quality Not Compromise”, and this is ingrained in every aspect of our business – from an unwavering belief in the limitless potential applications of Low-Level Lasers, down to the care and quality of the smallest component of our devices. Just pick up any Erchonia® product, feel the quality of workmanship, and see the attention to detail that can only come from Erchonia’s near-complete control of the manufacturing and assembly processes that go into each product bearing the Erchonia® name. Read More