CDC Clinical Practice Guideline for Prescribing Opioids for Pain - Laser Therapy Now Recommended

"This guideline provides recommendations for clinicians providing pain care, including those prescribing opioids, for outpatients aged ≥18 years. It updates the CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 (MMWR Recomm Rep 2016;65[No. RR-1]:1–49) and includes recommendations for managing acute (duration of <1 month), subacute (duration of 1–3 months), and chronic (duration of >3 months) pain."

"This clinical practice guideline is intended to improve communication between clinicians and patients about the benefits and risks of pain treatments, including opioid therapy; improve the effectiveness and safety of pain treatment; mitigate pain; improve function and quality of life for patients with pain; and reduce risks associated with opioid pain therapy, including opioid use disorder, overdose, and death."

"Clinicians should recommend appropriate noninvasive nonpharmacologic approaches to help manage chronic pain ... such as low-level laser therapy..."

READ THE FULL GUIDELINES HERE

Class 4 Laser Therapy: From Maligned Modality to Clinically Recommended Treatment

Class 4 therapy lasers were first FDA cleared in December 2003, and since then treatments have improved the quality of life for tens of thousands of human and animal patients. Those who criticize, defame, discredit, disgrace, impugn or in any way speak negatively about class 4 laser therapy need to stop it.

September 2022 is Drug-Free Pain Management Awareness Month

Opioid pain medications work in the nervous system or in specific receptors in the brain to reduce the intensity of pain. More than 191 million opioid prescriptions were dispensed to American patients in 2017, and the most common drugs involved in prescription opioid overdose deaths include Methadone, Oxycodone, and Hydrocodone[1].

Up to 25% of patients receiving long-term opioid therapy struggle with opioid addiction[2]. In 2016, more than 11.5 million Americans reported misusing prescription opioids in the previous year[3].

Prescription opioid use and abuse leading to addiction and catastrophic outcomes remains a national crisis. The leading cause of injury death in the United States is drug overdose[4], and most of the deaths from drug overdose deaths involved an opioid. From 1999 to 2020, more than 263,000 Americans have lost their lives to overdoses involving prescription opioids[5].

Because many die prematurely, surviving family members and communities lose out on benefits from an individual’s lifetime earnings. Opioid use disorder also results in costs associated with added health care expenses, criminal justice, lost productivity, and reduced quality of life. In 2017, these costs totaled an estimated $1.02 trillion—54% was attributed to overdose deaths and 46% to opioid use disorder[6].

Overdose deaths involving prescription opioids nearly increased by five times from 1999 to 2020[7]. We are losing 187 people a day from opioid overdoses and 68,630[8] people died from opioid overdoses in the U.S. in 2020 (74.8% of all drug overdose deaths).

Prescription opioids are often recommended for low back, neck, and musculoskeletal pain management, as well as for patients suffering from peripheral neuropathy. More than 100 million suffer with chronic pain and an estimated 80 percent of all Americans will experience some form of back pain during their lifetime.

On October 24, 2018, President Donald Trump signed the Opioid Crisis Response Act (OCRA) into law. OCRA received overwhelming bi-partisan support in both Chambers. HR6, which is now Public Law 115-271, broke new ground in being the first legislation to mandate aggressive development and adoption of alternative pain treatments that include “innovative medical technologies for pain management”. On October 11, Congress held its first ever briefing on ending opioid use through “innovative medical technologies for pain management”. Photobiomodulation (PBM) was the featured technology^[9].

Summus Medical Laser devices are class 4 therapeutic lasers, FDA-cleared as adjunctive devices for the temporary relief of pain^[10]. Photobiomodulation (PBM) utilizes non-ionizing red and infrared laser light and is a non-thermal process involving endogenous chromophores eliciting photochemical events at various biological scales.

PBM treatments are shown to resolve inflammation, improve peripheral circulation, modulate pain, and enhance tissue healing.^[11]

PBM treatments delivered with a class 4 therapeutic laser are shown to significantly reduce symptoms in patients with chemotherapy-induced peripheral neuropathy^[12] and significantly reduce pain and improve the quality of life of older patients with painful diabetic peripheral neuropathy^[13].

Summus Medical Laser treatments are non-invasive, pain-free, have no side effects yet are proven to be effective for both superficial wounds and deep neurological conditions.

SUMMARY

Photobiomodulation treatments delivered with a Summus Medical Laser class 4 therapeutic laser are a proven non-invasive opioid-free solution for pain management, with concomitant societal improvement and health care savings.

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[1] https://www.cdc.gov/opioids/basics/prescribed.html

[2] Banta-Green CJ, Merrill JO, Doyle SR, Boudreau DM, Calsyn DA. Opioid use behaviors, mental health and pain—development of a typology of chronic pain patients. Drug Alcohol Depend 2009;104:34–42

[3] Centers for Disease Control and Prevention. 2018 Annual Surveillance Report of Drug-Related Risks and Outcomes — United States. Surveillance Special Report 2pdf icon. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services.

[4] https://health.gov/healthypeople/objectives-and-data/browse-objectives/injury-prevention

[5] https://www.cdc.gov/drugoverdose/deaths/prescription/overview.html

[6] Curtis Florence, Feijun Luo, Ketra Rice. The economic burden of opioid use disorder and fatal opioid overdose in the United States, 2017. Drug and Alcohol Dependence, 2021-01-01, Volume 218, Article 108350.

[7] https://www.cdc.gov/drugoverdose/deaths/prescription/overview.html

[8] https://www.cdc.gov/drugoverdose/deaths/index.html

[9] https://citizenoversight.blogspot.com/2018/11/ending-opioid-use.html

[10] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=ILY

[11] https://journals.sagepub.com/doi/abs/10.1258/ebm.2012.012180

[12] https://pubmed.ncbi.nlm.nih.gov/27887804/

[13] https://pubmed.ncbi.nlm.nih.gov/31405365/

3 Surprising uses for a Class 4 therapy laser

Three surprising uses for a class 4 therapeutic laser are acute injuries, idiopathic pulmonary fibrosis, and diabetic peripheral neuropathy. Thousands of patients have already benefited from these treatments and in the future class 4 therapeutic laser treatments will be an integral modality in all fields of health care.

Class 4 therapeutic lasers first gained FDA clearance in December of 2003. Before then therapeutic lasers cleared by the FDA and most of them used in healthcare and in laser studies were class 3 devices. While the true definition of laser class is degree of hazard to the naked eye, the power cut-off between class 3 and class 4 is 500 milliwatts or half of a Watt. Early on, class 4 devices were first perceived as being too powerful.

In 1988 laser scientist Dr. R. Glen Calderhead introduced the term “low level laser therapy” to the medical scientific literature. Dr. Calderhead was very specific - he intended the term to be used in reference to the reaction at the tissues and not to the output power of the device. This is a very important distinction. Unfortunately, in the past few years many people have altered this definition and will talk about ‘low level lasers’ in reference to the output power of the device.

Class 4 therapeutic lasers are FDA cleared class 2 medical devices. They have been used safely and effectively in both human and animal medical care for more than 18 years. Scientific researchers have concluded that to deliver a therapeutic dosage to tissues deep inside of the body a higher-powered laser must be shined at the skin surface. It only makes sense. As light enters the body it will get dimmer and dimmer as it passes through the tissues. Photons get absorbed, and the light gets dimmer.

Class 4 therapeutic lasers use infrared wavelengths, ranging from 800 to 1064 nanometers. With any of the infrared wavelengths there will be a small amount of tissue heating during the treatment. The 980-nanometer wavelength is at a small peak of absorption for water molecules, so when this wavelength is used, there will be a little bit more tissue heating.

Detractors of class 4 therapeutic laser claim that they should not be used on acute injuries due to tissue heating. The amount of tissue heating during a properly delivered class four therapeutic laser treatment has been measured. It is less than two degrees Fahrenheit. And when proper settings are used for acute injuries, there is no tissue heating at all. This is very important.

Numerous studies support the benefits of applying laser therapy two acute injuries. For the athlete with the sprained ankle, the general patient in the motor vehicle accident, or for anyone who has an acute injury they can and should be getting treatment with a class 4 therapeutic laser as soon as possible.

In 2014, a chiropractor by the name of Dr. Andrew Hall was diagnosed with idiopathic pulmonary fibrosis (IPF). He was told he had an 80% chance of dying within five years. IPF is a terminal and progressive disease. The scar tissue in the lungs interferes with oxygen exchange the patient's blood oxygen levels slowly decrease. It is a long, slow and painful death.

Given this diagnosis, Dr. Hall decided to treat himself with his class 4 therapeutic laser. After a few months he had a follow up visit with his pulmonologist who expressed great surprise at finding that Dr. Hall’s pulmonary function tests and blood oxygen levels had improved! That never happens with IPF!

As time went by Dr. Hall continued to treat himself with his class 4 therapeutic laser. Since then, studies have shown that infrared therapeutic laser will help to prevent scar tissue from growing in the lungs and can also help with remodeling to healthy collagen tissues.

Dr. Hall has created a website, ipflaserstudy.com on which he gives information about therapeutic laser treatments for IPF. He continues to be active today, more than seven years after his initial diagnosis. He has shared treatment information with doctors around the world and hundreds of patients have benefited from the laser treatments.

Diabetic peripheral neuropathy is another progressive disease for which modern medicine does not have an answer. High blood sugar levels slowly degrade the lining of the arteries in the extremities. The legs, foot and toes are most affected because the effects of gravity and the length of the nerves that travel from the spinal cord to the toes. Lack of blood flow to the peripheral nerves leads to improper nerve function and the patient will experience bizarre sensations such as tingling and numbness, feeling like they are standing on marbles or in a campfire, and they may need to wake up in the middle of the night to rub their feet and stop the pain.

Class 4 therapeutic lasers help to improve peripheral circulation and improve the function of the peripheral nerves. This helps to restore proper sensation and reduce the symptoms associated with diabetic peripheral neuropathy. There are no side effects and studies have suggested a greater than 90% success rate in alleviating symptoms associated with diabetic peripheral neuropathy.

Three surprising uses for a class 4 therapeutic laser are acute injuries, idiopathic pulmonary fibrosis, and diabetic peripheral neuropathy. Thousands of patients have already benefited from these treatments and in the future class 4 therapeutic laser treatments will be an integral modality in all fields of health care.

How Photobiomodulation is changing healthcare

The use of lasers in healthcare has a very interesting history. Albert Einstein first theorized the possibility of building a laser device in the early 1900s. In the 1960s Theodore Maimon invented the first laser and soon afterwards nearly all of the laser types used in healthcare were invented.

In 1967 physician Andre Mester was trying to repeat experiments showing that lasers could be used to treat malignant tumors. Mester’s laser device was very low in power and did not have an effect on the tumors; however, it did cause more rapid hair growth in the test animals. This accidental discovery was the landmark moment in the history of laser therapy.

In 2015 a worldwide panel of experts convened to agree upon a term that would be acceptable to everyone involved, that would describe the effect of therapeutic lasers, and would take the place of the dozens of terms being used to that time (i.e., cold laser, low-level laser, low-reactive laser, etc). The term they agreed upon was “photobiomodulation”: using light to modulate biological processes.

The official definition is, “A form of light therapy that utilizes non-ionizing forms of light sources, including LASERS, LEDs, and broad-band light, in the visible and infrared spectrum. It is a non-thermal process involving endogenous chromophores eliciting photophysical (i.e., linear and non-linear) and photochemical events at various biological scales. This process results in beneficial therapeutic outcomes including but not limited to the alleviation of pain or inflammation, immunomodulation, and promotion of wound healing and tissue regeneration.”

From the 1970s through the 2000s therapeutic lasers used in healthcare were very low in power, being class three laser devices. Like a light bulb, low power with a therapy laser means that the light is not very bright. A 40-Watt light bulb would not be sufficient to fully illuminate a large room. In similar way the earliest therapeutic laser devices were not powerful enough to deliver light deep into the body.

The first therapeutic laser to gain FDA clearance used 100 milliwatts of power and an 830-nanometer wavelength. It was used to treat carpal tunnel syndrome in automobile factory workers. The nerves in the wrist are not very deep, so photons from that device could reach the nerves and have a beneficial effect. However, these devices would not be very effective at treating low back pain, hip pain or at reaching any other tissue deep inside the body.

In 2003 the FDA gave clearance to the first class 4 therapy laser device. In the 18 years since then class 4 therapy lasers have virtually become standard of care in health care clinics treating both human and animal patients. Veterinarians use class 4 therapeutic lasers to treat conditions ranging from post-surgical incision healing to canine ear infections to osteoarthritis and hip dysplasia.

Today in human medicine, therapeutic lasers are used in chiropractic offices for musculoskeletal pain and ailments. They are used in physical therapy clinics, pain management clinics, and concierge medical clinics. Class 4 therapeutic lasers are used widely in sports athletic training rooms. Athletic trainers have realized the benefit of using laser therapy over ice for acute injuries.

Regenerative medicine is the use of various injections to stimulate healing in the body. These would include prolotherapy, platelet rich plasma therapy, and stem cell injections. Whenever these injections are performed the patient will have significant post injection pain. Class 4 therapeutic lasers can be used immediately after these injections to help with that pain.

New studies are showing that therapeutic lasers help with the effectiveness of regenerative medicine injections. We are on the brink of an exciting field in health care. New techniques, materials and methods are showing great promise to help patients recover from traumatic injuries, peripheral neuropathy, neuro degenerative diseases and more.

Photobiomodulation is here to stay. Class 4 therapeutic lasers are here to stay. In the 18 years since gaining FDA clearance the numbers of units used in healthcare has grown exponentially. The future is bright - these devices will become standard of care in all healthcare disciplines.