Nordics - Treatment Guide for Lower Leg Injuries

Shockwave and Laser Therapy Treatment guide for Lower Leg Injuries

TABLE OF CONTENTS

Runners want to run, getting them safely back to activity

Introduction of ESWT (FSW and RSW) for running injuries

What effect does ESWT have on tendinopathies?

Why runners love laser therapy

Photobiomodulation (PBM) therapy

Photobiomodulation for common running injuries

A simple treatment option for runners

The effect of high-intensity versus low-level laser therapy in the management of plantar fasciitis: a randomized clinical trial

22 Clinical effectiveness of multi-wavelength photobiomodulation therapy as an adjunct to extracorporeal shock wave therapy in the management of plantar fasciitis: a randomized controlled trial 23 Running injury product toolkit 24 About Chattanooga ®

RUNNERS WANT TO RUN HOW TO GET THEM SAFELY BACK TO RUNNING If you treat runners, then you know there is one constant- they just want to run. In this eBook we’ll explore ways to help them get back in action when they experience a lower leg injury.

In this ebook we will share ways to help runners safely get back to what they love doing. There will be a focus on how Shockwave and High Intensity Laser Therapy (along with low level laser therapy researchers now refer to these therapies as Photobiomodulation) can help address painful lower limb injuries.

SHOCKWAVE THERAPY FOR RUNNING INJURIES

Terminology

Names that refer to therapeutic shockwave are varied. This can create confusion when trying to investigate this technology. Common names include but are not limited to:

ESWT: Extracorporeal Shockwave Therapy FSW: Focused Shockwave EPAT: Extracorporeal Pulsed Activation Therapy

RSW: Radial Shockwave AWT: Acoustic Wave Therapy

What is Shockwave Therapy?

Soft tissue injuries are common to runners and athletes that depend on their legs to get them where they need to go. About 65% of regular runners get hurt each year. It’s estimated that the average runner will sustain one injury for every 100 hours he or she runs . 1 When an injury occurs, athletes and weekend warriors are usually looking for solutions to get them back on the road as soon as possible. Shockwave therapy transmits harmless acoustic pressure waves into tissue to influence biological activity, resulting in an analgesic effect and expediting the healing process. There are two types of shockwave, Focused Shockwave and Radial Shockwave. These should not be confused with High Energy devices used in Lithotripsy (breaking down kidney stones).

Shockwave therapy can treat

• •

Myofascial Trigger Points 2 Reduce Muscle Pain & Aches 2

• Plantar Fasciitis and Non Specific Heel Pain 2,3 • Lower Limb Tendinopathies 2 • Hip and Groin Tendinopathies 2

The list of indications continues to grow as the literature base expands.

Research has shown that Shockwave therapy can provide up to 89% positive outcomes after 3 one weekly sessions versus placebo or alternative treatment modalities when treating different types of tendinopathies. 4

HOW DOES SHOCKWAVE HELP TISSUE?

Low to medium energy waves, that can be created via different mechanisms, create a phenomenon referred to as mechanotransduction. In simple terms, it is the process of imparting brief, physical deformation to cells that lead to biochemical changes. These changes have the potential to positively impact pain and tissue repair. 5

“Mechanotransduction” is a biological pathway to which many cell types (including Stem Cells) sense and process the mechanical information from the extracellular environment. These biomechanical forces are converted in biochemical responses, thus influencing some fundamental cell functions such as migration, proliferation, differentiation, and apoptosis. 6

ARE ALL SOUNDWAVES THE SAME?

Some clinicians falsely assume that shockwave equipment is similar to

therapeutic ultrasound (US) since they both utilize soundwaves. It should be noted that therapeutic ultrasound uses a lower intensity sound wave (20 to 1000 mW/cm 2 ) that is delivered at a higher frequency (0.7 to 3.3 MHz.). 8 Therapeutic US waves look like this:

Image obtained from reference 7 in the bibliography.

Continuous US creates thermal effects in tissue by alternating compression and rarefaction of sound waves within tissue. Maximum energy absorption in soft tissue occurs from 2 to 5 cm and intensity decreases as the waves penetrate deeper. 8

Hopefully this review will provide some clarity for readers that are looking to better understand how ESWT can help various conditions.

FOCUSED VERSUS RADIAL SHOCKWAVE

Focused Shockwave (FSW) impulse and penetration

Radial Shockwave (RSW) impulse and penetration

Clearly the most notable difference is the impulse they create. FSW devices create a ‘true’ shockwave. RSW create what has been termed as a Radial Pressure Wave (RPW). Hence why you will see this term used for RSW along with others including Extracorporeal Activation Therapy (EPAT). At the time of its conception in 1998, RSW was marketed as Radial Shockwave and it is still marketed this way today. Comparative research studies between the FSW and RSW for lower limb tendinopathies on the whole shows no significant difference in outcomes. This is with the exception of insertional tendinopathies, where FSW has been shown to be more effective. So apart from this, why choose FSW, as it is more expensive? For therapists the additional cost is warranted if they are seeing bone pathologies, calcific deposits, deep structures or treating men’s health issues. There are three ways to generate a focused shockwave. The two most widely used in clinics are electromagnetic and Piezoelectric. Both transmit the shockwave energy over a large area of the skin and the energy is then cumulated to a focal point with in the tissue. This means that the energy transmission is acceptable to most patients. With electromagnetic generation the focal point is around 6cm deep with a therapeutic effect down to 12cm. To treat more superficial tissue than this the focal point is raised by stand offs that are fitted to the handpiece. The energy of focused shockwaves is measured in mJ/mm 2 and is referred to as the Energy Flux Density (EFD).

15-45mm focal zone

0-30mm focal zone

FOCUSED SHOCKWAVE STAND OFFS FOR TREATING MORE SUPERFICIAL STRUCTURES

For Radial shockwave devices there are two types of generation, air compressor or electromagnetic. The latter being quite new to the market and currently not supported by any robust or reliable research evidence. The energy from these devices are transmitted through transmitters. The shape, design and material of these transmitters determines the amount of energy being produced. Inevitably there is a huge variation in type and quality between different manufacturers. Only a few manufacturers publish the EFD value of their transmitters. Most simply quote bar pressure. This is the pressure created within the barrel of the handpiece. However, two different manufacturer’s devices, at the same bar pressure, can produce different EFD vales from their respective transmitters. For runners who may have tried shockwave treatments unsuccessfully you may well find success with a different radial shockwave device.

The role of shockwave in lower leg running injuries

Tendinopathy is defined as inflammation of the tendon and results from micro-tears that happen when the musculotendinous unit is acutely overloaded with a tensile force that is too heavy and/or too sudden. 9

Symptoms can include localized pain, possible inflammation around the tendon, and pain with exertion.

Symptoms can last from days to 6 weeks depending on when treatment starts. 10

“Tendinopathy can occur in any tendon. But it’s most common around shoulders, elbows, wrists, knees and heels.” 11

WHAT EFFECT DOES ESWT HAVE ON TENDINOPATHIES?

It was believed, in the past, that tendons could not undergo matrix turnover and that tenocytes were not capable of repair. However, it has been shown more recently that Matrix metalloproteinases (MMPs) have a very important role in the degradation and remodeling of the Extra Cellular Matrix (ECM) during the healing process. 12 In a human in-vivo study two groups agreed to having micro dialysis into their Achilles and Patella tendons. 13 There was a pathological group and a healthy group. Both groups received a single application of Radial Shockwave therapy. A five fold increase in the production of MMPs was demonstrated with the pathological group producing three times more MMPs than the healthy group. The research showed that, after a single treated of Radial shockwave, the pathological group reported a 60% improvement in their symptoms. This finding, along with animal studies showing that there is an increase in the quantity of capillaries present four weeks post shockwave therapy, provides some explanation as to why Shockwave therapy provides such good results in tendinopathy management.

MYOFASCIAL TRIGGER POINTS (MTrP)

Myofascial Trigger points (MTrP) are hyperirritable, mostly palpable nodules in the muscle causing local or referred pain and can restrict range of movement. 14 They are always associated with a tendinopathy and must be addressed in tendinopathy management. Both FSW and RSW have been shown to alleviate the symptoms of MTrPs very effectively.

The goal of treating trigger points with RSW equipment is to localize and deactivate them.

Trigger points are localized by passing the transmitter over the muscle region being treated. Muscle tissue that is in a normal state will generally have no reaction to passing over the area with the shockwave therapy set at this level. Once an irritable area is located, there will be immediate subjective feedback from the patient which will help localize the MTrP. If the pain in the area doesn’t resolve in 500-1000 pulses, deactivating the MTrP may require using a higher energy level to help resolve the complaint. 2 Multiple painful areas can contribute to the primary MTrP, so additional pulses may also be given in those areas to help resolve the MTrP. Addressing MTrP in this fashion should result in improved range of motion (ROM), improved tissue texture, and reduced subjective pain levels not only after treatment, but can impact pain associated with MTrP for as long as 3 months. 15

HOW IS RADIAL SHOCKWAVE THERAPY MODIFIED TO HELP TREAT DIFFERENT RUNNING INJURIES?

Radial shockwave energy delivery is modified by the following:

• The volume of shocks provided. Most studies, and Chattanooga, recommend 2000 pulses per location when treating tendon dysfunction. Trigger points may require fewer shocks. Patient biofeedback will dictate length and intensity of treatment over an area. • The rate at which the shocks are provided (Hz). Some patients will subjectively prefer higher frequency treatments. Treating at higher rates will also shorten treatment times. • The bar pressure of the machine which dictates the intensity of the radial pressure wave. Deeper tissue dysfunction requires higher bar settings in most cases.

• The applicator used. Softer materials transmit less energy and are useful for superficial tissues/ sensitive areas. Harder metals (steel and titanium) are used to treat deeper tissues as they transmit more energy into the tissue. Examples of different applicators are listed below:

F15 White soft transmitter 15mm for superficial pain regions, muscles of mastication. Penetration depth 0-30mm Intensity level: Very Low Ro40 15mm Energy beam transmitter with concave coupling surface, best for pain zones near the skin surface Penetration depth 0-35mm Intensity level: Medium DI15 Golden Depth 15mm Deep Impact ® transmitter for deep target areas, chronic disorder, local trigger points Penetration depth 0-60mm Intensity level: High

D20-S Standard Oscillator, 20mm transmitter or muscle and connective tissue Penetration depth 0-50mm Intensity level: Medium

C15 CERAma-x ® Ceramic Energy 15mm transmitter for any type of tendonopathies Penetration depth 0-35mm Intensity level: High

WHY CHOOSE RSW TO TREAT TENDONS IN THE KNEE, ANKLE, AND FOOT? ARE THERE ANY OTHER BENEFITS OF USING RSW VS FSW EQUIPMENT?

Early research, using rabbit’s achilles tendons demonstrated that successful outcomes could be attained using less tha 0.28mJ/mm2 EFD. Current research tells us that the best results come from using medium energy values (0.1-0.28mJ/mm2). 16 Chattanooga RSW devices do provide the EFDs of their transmitters. With this information and knowledge of the attenuation of sound waves through different human tissue. Guidelines can be calculated converting bar pressure to EFD valies. These can only be guidelines as the morphology of a patient will determine the attenuation of energy passing through the various tissue to the target. The most widely used transmitter in the Chattanooga range is the D20. For very deep structures the D20T should be considered.

CAN’T I GET THE SAME RESULTS WITH FRICTION MASSAGE? Friction massage is used to increase circulation and release areas that are tight; particularly around joints and where there are adhesions within the muscles or tendons. 17 Manually moving tissue in this fashion is actually another form of mechanotransduction. However, the practice is generally not comfortable for patients and can only be applied to superficial structures. Applying these techniques at depth is not tolerated by most patients.

Luckily, ESWT therapies are more comfortable and have the ability to reach much deeper tissues. An added benefit is that these devices also require significantly less work by the practitioner which can help save a clinician’s most valuable equipment, their hands!

SUPPORTIVE EVIDENCE FOR LOWER LEG RUNNING INJURIES

Research shows that radial shockwave treatment is most effective when included as part of comprehensive plans of care that include stretching and exercise. 18 Learn More at pubmed.ncbi.nlm.nih.gov/25940060/

Management of plantar heel pain: a best practice guide informed by a systematic review, expert clinical reasoning and patient values provides best practices to include conservative treatment in the first 4-6 weeks of plantar fasciitis (outlined below). When pain persists beyond 6 weeks, the evidence supports ESWT as the next best course of treatment followed by custom orthotics. 19 This research included feedback from both the clinician and the patient.

Learn More at bjsm.bmj.com/content/55/19/1106

The review revealed the following best practices guidelines for ESWT:

• The core approach (taping, stretching, exercising, and educating) should be used for approximately 4-6 weeks before consideration of adjunctive interventions such as ESWT or orthoses. 19 • ESWT had the best evidence of any adjunctive treatment, including dry needling, if the core approach was unsuccessful at 4-6 weeks. 19 • ESWT had minimal documented adverse events and positive efficacy in the short term, medium term, and long term for the most patient-reported outcomes. 19 • With this in mind many therapists choose to teach patients the ‘Core approach’ but then commence ESWT straight away. Rather than waiting 4- 6 weeks when we have seen that after three weeks, we can achieve up to 89% positive outcomes with ESWT versus placebo and alternative treatment modalities when treating different types of tendinopathies. 4

Utilizing Extracorporeal Shockwave Therapy for in-Season Athletes reviews the use of ESWT to address sports-related injuries for in-season athletes to accelerate return to play. 20

Learn More at www.mdpi.com/2227-9032/11/7/1006

Patient compliance, the role of modalities

Exercise is often uncomfortable but needed for patients suffering from Achilles and Patella tendinopathies and plantar fasciitis. 21 Adding modalities such as shockwave and laser therapy can help manage pain in the clinic which can open doors to more advanced loading exercises. Keeping pain in check can help promote steady progress over the 3-4 week course of treatment commonly needed to restore higher levels of function when adding ESWT to a plan of care (POC).

Quick review of how to use shockwave for runners:

• ESWT is a trusted treatment option for clinicians treating pain associated with a variety of tendinopathies, with unique advantages relative to other interventional treatments. • RSW technology is the most commonly used ESWT device globally. This is partially due to the lower costs associated with these devices which makes them an attractive entry point into shockwave technology. While cost is one factor, RSW popularity is primarily due to its effectiveness in helping to treat tendon disorders. A 2015 systematic review showed that RSW treatments were 88.5% effective when compared to other treatments for common musculoskeletal pathologies. FSW was found to be 81.5% effective in the same study. 4 While the physical properties of the RPW differ from the FSW, RSW has been repeatedly shown to be as effective in treating soft tissue pathologies in the extremities as FSW where tendons are relatively superficial. 4 • FSW can provide higher energy treatments at depths of up to 12.5 cm. While potent, FSW has the ability to be more precise with the energy it delivers and at specified depths. This is ideal for clinicians that utilize diagnostic ultrasound to identify the depth and degree of soft tissue lesions they are treating. FSW is very simple to use as it allows clinicians to apply specific energy levels (mJ/mm 2 ) at precise depths by dialing in the desired energy flux density (EFD) on the screen and then setting the treatment depth of the focal area by choosing the correct stand-off that fits on the handpiece.

WHY RUNNERS LOVE LASER THERAPY

For so many, running is more than exercise – running is freedom. It’s an emotional and physical triumph for the human body. There is nothing else like it. Human beings were born to run. In fact, it is a critical survival skill. Just ask our ancestors that ever faced a hungry bear!

Running into problems

However, while enjoyable to many, running comes with risks. Applying repeated, high loads to the body can often result in injuries due to poor load management by novice runners or athletes that are ignoring signs of overuse.

Common areas of injury for runners include hip, lower leg, lower back, and knee.

These areas can be influenced by problems in the kinetic chain when mechanical issues are present at one or more joints in the system. It is not uncommon that poor lower extremity mechanics can result in joint pathology over time.

Combine joint dysfunction with weak muscles or muscle imbalances that may or may not be related to joint pain and you have multiple factors that can contribute aches and pains in the body.

Often runners turn to NSAIDs (Nonsteroidal anti-inflammatory drugs) to help manage inflammation and pain. While many clinicians know that when taken for prolonged periods these meds can negatively impact the stomach and other organs, fewer clinicians realize that NSAIDs can have negative impacts on scar formation and muscle repair which can predispose athletes to chronic muscle strains. 43 An alternative solution for patients may be High Intensity Laser Therapy, now correctly referred to as Photobiomodulation Therapy (PBMT) - light that changes biological activity.

PHOTOBIOMODULATION (PBM) THERAPY A proven way to impact tissue at the cellular level Photobiomodulation therapy (PBMT) is a form of light therapy based on the photochemical process called photobiomodulation (PBM). In photobiomodulation therapy, a light source is placed near or in contact with the skin, the light energy penetrates the skin reaching the mitochondria of damaged or diseased tissue leading to photobiomodulation. This process can result in beneficial therapeutic outcomes such as the alleviation of pain, increased blood flow, muscle relaxation, and relief from joint stiffness. 25-27 A proven way to impact tissue at the cellular level Photobiomodulation therapy (PBMT) is a form of light therapy based on the photochemical process called photobiomodulation (PBM). In photobiomodulation therapy, a light source is placed near or in contact with the skin, the light energy penetrates the skin reaching the mitochondria of damaged or diseased tissue leading to positive biological change, resulting in expediting the healing process and alleviating pain. 22-24 PHOTOBIOMODULATION THERAPY (PBMT)

PBM mechanisms of action

PBM mechanisms of action The application of a therapeutic dose of light to impaired or dysfunctional tissue leads to a cellular response mediated by mitochondrial mechanisms involved in pain relief and tissue repair processes . 26 The primary target (chromophore) for the process is the cytochrome c complex which is found in the inner membrane of the cell mitochondria. Cytochrome c is a vital component of the electron transport chain that drives cellular metabolism. As light is absorbed, cytochrome c is stimulated, leading to increased production of adenosine triphosphate (ATP), the molecule that facilitates energy transfer within the cell. 26-28 The primary target (chromophore) for the process is the cytochrome c complex which is found in the inner membrane of the cell mitochondria. Cytochrome c is a vital component of the electron transport chain that drives cellular metabolism. As light is absorbed, cytochrome c is stimulated, leading to increased production of adenosine triphosphate (ATP), the molecule that facilitates energy transfer within the cell. 23-25 In addition to ATP, laser stimulation also produces free nitric oxide and reactive oxygen species. Nitric oxide is a powerful vasodilator and an important cellular signaling molecule involved in many physiological processes. Reactive oxygen species have been shown to affect many important physiological signaling pathways including the inflammatory response. In concert, these molecules have been shown to increase growth factor production and promote extracellular matrix deposition. The resultant increase in cell proliferation and motility leads to pro-survival pathways for the cell . 26-28 In addition to ATP, laser stimulation also produces free nitric oxide and reactive oxygen species. Nitric oxide is a powerful vasodilator and an important cellular signaling molecule involved in many physiological processes. Reactive oxygen species have been shown to affect many important physiological signaling pathways including the inflammatory response. In concert, these molecules have been shown to increase growth factor production and promote extracellular matrix deposition. 23-25 The application of a therapeutic dose of light to impaired or dysfunctional tissue leads to a cellular response mediated by mitochondrial mechanisms involved in pain relief and tissue repair processes. 23

Physiological effects • A nalgesic • Increased tissue oxygenation and nutrition • Increased synthesis of ATP • Impacts the biochemical pathways involved in tissue repair • Increased microcirculation Physiological effects 26 • Analgesic • Increased synthesis of ATP

Increased tissue oxygenation and nutrition

• •

Impacts the biochemical pathways involved in tissue repair

Jun/Fos

AP-1

Mitochondria

ATP

Gene Transcription

•

Increased microcirculation

lkB

NO ROS-

NF-kB

HIF-1 α

NF-kB

CA 2+ /NA + Antiporter NA + /H + Antiporter NA + , K + -ATPase CA 2+ Pump ∆CA 2+ , K + ∆cAMP, ∆pH

APPLICATIONS & DELIVERY Versatile applications, consistent results APPLICATIONS & DELIVERY Versatile applications, consistent results

APPLICATIONS & DELIVERY Versatile applications, consistent results Use photobiomodulation therapy in conjunction with other modalities and treatment techniques with a low risk of side effects. • Acute Conditions • Chronic Conditions Use photobiomodulation therapy in conjunction with other modalities and treatment techniques with a low risk of side effects. • Acute Conditions • Chronic Conditions Use photobiomodulation therapy in conjunction with other modalities and treatment techniques with a low risk of side effects. • Acute Conditions • Chronic Conditions

Address pain related to: Address pain related to:

TMJ 29,30 27,28

Multiple Tissues: • Tendons • Ligaments Multiple Tissues: • Tendons • Ligaments • Joint Capsules •Muscles • And More Multiple Tissues: • Tendons • Ligaments • Joint Capsules •Muscles • And More • Joint Capsules • Muscles • And More

Neck 31

TMJ 29,30

Shoulder 32,33 30,31

Neck 31

Shoulder 32,33

Elbow 34 Elbow 32

Low Back 35 33

Elbow 34

Low Back 35

The benefits of the massage ball Help maximize clinical results with the benefits of LightForce’s patented, on-contact photobiomodulation therapy treatment application. The b enefits of the massage b all Help maximize clinical results with the benefits of LightForce’s patented, on-contact photobiomodulation therapy treatment application. The b enefits of the massage b all Help maximize clinical results with the benefits of LightForce’s patented, on-contact photobiomodulation therapy treatment application.

Sports Injuries 37 Sport Injuries 35

Sports Injuries 37

Arthritis 36 34

Arthritis 36

Plantar Fasciitis 38 36

Plantar Fasciitis 38

COMPRESSION Gets you closer to target tissue. Blanching reduces obstacles of superficial absorbers COLLIMATION The massage ball acts to collimate the delivery of light to tissue reducing energy loss COLLIMATION The massage ball acts to collimate the delivery of light to tissue reducing energy loss REFRACTIVE INDEX The fused silica composition of the massage ball minimizes light losses as it passes from the massage ball into the skin due to similar refractive indices REFRACTIVE INDEX The fused silica composition of the massage ball minimizes light losses as it passes from the massage ball into the skin due to similar refractive indices REFRACTIVE INDEX The fused silica composition of the massage ball minimizes light losses as it passes from the massage ball into the skin due to similar refractive indices COMPRESSION Gets you closer to target tissue. Blanching reduces energy absorption by superficial blood vessels COMPRESSION Gets you closer to target tissue. Blanching reduces obstacles of superficial absorbers COLLIMATION The massage ball acts to collimate the delivery of light to tissue reducing energy loss

REFLECTION Contact application of delivery to tissue minimizes energy loss due to reflection SOFT TISSUE WORK Allows you to do manual soft tissue work with the massage ball applicator while delivering energy SOFT TISSUE WORK Allows you to do manual soft tissue work with the massage ball applicator while delivering energy SOFT TISSUE WORK Allows you to do manual soft tissue work with the massage ball applicator while delivering energy REFLECTION Contact application of delivery to tissue minimizes energy loss due to reflection REFLECTION Contact application of delivery to tissue minimizes energy loss due to reflection

PHOTOBIOMODULATION DOSING A drug-free, surgery-free, non-invasive pain treatment alternative PBM dosing - the k ey to results Dosimetry in photobiomodulation (PBM) therapy is highly complicated - no single “dose” will work for all possible PBM therapies, and in some cases, different dosimetries can be equally effective. Safe and effective PBM dosimetry must consider multiple treatment parameters including: wavelength, irradiance (often called power density or brightness), and irradiation time . 28 In-vivo studies have shown us that tissue with higher numbers of mitochondria, like muscle, which also tend to be deeper, respond best to higher dosages. While those tissues with lower numbers of mitochondria, like skin and tendons, that tend to be more superficial, respond best to lower energy dosages. To ensure safe and effective treatments LFT devices provide guidelines for Fluence (dosing ) of different pathological presentations. 38 Furthermore, it is important to recognize that PBM is challenged by energy loss that occurs as light enters the skin and travels from superficial to deeper tissues. At the skin’s surface this is primarily due to reflection and below the surface by absorption from different tissues competing for different wavelengths of light. Proper configuration of the laser is a key factor in getting sufficient energy to target tissues. EU Medical Device classification is based on risk PHOTOBIOMODULATION DOSING A drug free, surgery free, non-invasive pain treatment alternative Fluence (dosage) is measured in J/cm2 in High Intensity (HI) PBMT devices. What we have learnt from Low Level Laser research is that outcomes are dosage dependent. 37

LASER classes - what do they mean? Laser devices are classified by the FDA according to their output power. For Photobiomodulation there are two common classifications:

•

Lightforce Therapy devices are classified as Class IIa, low risk

Factors that impact dose delivery at depth • Wavelength • Irradiance (power & beam area) • •

Laser classes - what do they mean? Lasers are classified by the FDA according to their output power. In the field of photobiomodulation therapy, there are two common laser classifications: • Currently all other Class IV HI PBMT devices are classified Class IIb, moderate risk • Class IIIb, Maximum power output of 0.5 watts • Class IV, Maximum power output of over 0.5 watts This means that Lightforce Therapy devices are a safe HI PBMT device

Class IIIb that have a maximum power output of 0.5W (typically 0.2-0.3W) Class IV that have power over 0.5W

Both classifications require both the user and patient to wear protective eyewear during emission

• Mechanism of delivery (contact vs. non-contact) • Treatment time • Size of treatment area • Type of tissue

Both Class IIIb and Class IV lasers require that safety eye protection be worn during emission.

The impact of power on treatment time Power is a key factor when delivering a therapeutic dose to deep target tissues. Not only do LightForce® lasers have higher output powers, but they also have larger beam areas, making them more capable of delivering a therapeutic dose to larger treatment areas. For example, to effectively treat a 300 cm 2 thoracic spine at 10 J/cm 2 , 3,000 joules of energy are required at the surface of the skin to deliver a therapeutic dose at depth. How long would that treatment take with a Class IIIb laser vs. a Class IV laser? For example, for treating a large area, such as the lower back, around 300cm 2 at 10J/cm 2 requires a total of 3000J. Compare the treatment times for a typical, single probe, LLLT device (2mW) and a 25W Lightforce device The impact of Irradiance (W/cm 2 ) on treatment time and therapeutic penetration Irradiance is a key factor when delivering a therapeutic dosage to deep target tissue. The power (W) of a device is spread over an area determined by the beam size. Not only do Lightforce Therapy devices have high power but also a large beam size. This means that they are capable of delivery more photons to deeper structures and larger areas, providing faster treatment times

Class IIIb 3,000 J at 0.5 W = 100 min Class IIIb 3000J at 0.2W = 250 minutes

Class IV 3,000 J at 15 W = 3.3 min Class IV 3000J at 25W = 2 minutes

PHOTOBIOMODULATION FOR COMMON RUNNING INJURIES Photobiomodulation has been shown to reduce the amount of exercise required to recover from achilles tendinopathy. The following study by Tumilty 39 showed that exercising 2 times a week when combined with therapeutic laser provided equivalent outcomes to a group that had to exercise 2 sessions per day on a daily basis when not utilizing laser. This is important as patient compliance can be significantly improved when required to exercise 2 times a week compared to 14 times!

Here is a brief summary of the findings of Photobiomodulation and eccentric exercise for Achilles tendinopathy: a randomized controlled trial:

• •

Double blinded research

Participants were 18-65 years old

• Participants had experienced symptoms for over 3 months • There were 4 groups: • Twice a day, every day exercise + placebo laser • Twice a day, every day exercise + laser • Placebo laser + once a day, twice a week exercise • Laser + once a day, twice a week exercises

• Outcome measure: VISA-A (Victorian Institute of Sports Assessment-Achilles) • Findings: Patients achieved the same results incorporating high power laser with only 2 exercise sessions a week compared to the twice a day everyday exercise program.

Adding laser therapy to treatment protocols for Achilles tendinopathy enables patients to exercise less and achieve the same outcomes. 39 Learn More at pubmed.ncbi.nlm.nih.gov/26610637/

A SIMPLE TREATMENT OPTION FOR RUNNERS

PBMT helps reduce pain generated from both joints and muscles:

It is common for runners to have stiffness and pain in the lower leg, knee, and hip. Laser has the ability to relieve muscle and joint pain through the process of photobiomodulation. 40 This can help runners return to training when they would otherwise have to take days off due to pain. For runners that are looking for options to help them to bounce back after intense training sessions, laser has been shown to reduce delayed onset muscle soreness after training (DOMS). 41 This improved recovery has been attributed. to the increased production of ATP within healthy cells. When pain is more chronic in nature, for example when athletes try to run through painful arthritic pain, their muscles can restrict motion due to protective guarding. PBMT can be used before or after events to help reduce muscle spasm, pain and stiffness . 40 This can be a huge benefit for seniors trying to ready themselves for an event or manage their condition as they prepare for tackling longer distances. PBMT has also been shown to benefit knee OA by increasing the thickness of the hyaline cartilage that lines the knee joint.

Maximizing performance in shorter periods of time

Many clinics are looking for ways to increase cash revenue in their clinics or through community outreach. This can be done by treating runners on location before their races in a laser safe tent. LightForce ® High Intensity Lasers allow proper dosing to be applied to large areas of tissue, like the quadriceps, hamstrings, and lower leg in minutes! This is simply the result of utilizing higher power when treating which inversely impacts the amount of time needed for treatments. This can be a huge benefit when trying to work with a line of runners looking for treatment before an event or within a busy clinic when multiple patients are in need of laser therapy.

[Webinar]

CURRENT CONCEPTS IN CHRONIC TENDINOPATHY

Join Cliff Eaton, MSc, MCSP, International Clinical Support Specialist at Enovis, as we explore the latest strategies for managing chronic tendinopathy.

We’ll review a multimodal approach for addressing chronic tendinopathy, evidence-based practices, and tailored treatment protocols designed to optimize patient outcomes. This webinar is an excellent opportunity to refine your clinical approach and expand your expertise in tendinopathy care.

Key Learning Objectives:

• Review of tendon anatomy and pathology • The role of extracorporeal shockwave (ESWT) and laser therapies in effective tendon management • The use of Neuro Muscular Electro Stimulation throughout Rehab • Evaluating clinical outcomes using evidence and real-world case studies

Watch it now at https://enovisinstitutewebinars.learnupon.com/users/sign_ in?next=%2Fcatalog%2Fcourses%2F4253158

The effect of high-intensity versus low-level laser therapy in the management of plantar fasciitis: a randomized clinical trial 36 Banu Ordahan, Ali Yavuz Karahan, Ercan Kaydok

Published in: Lasers in Medical Science, 2018 https://doi.org/10.1007/s10103-018-2497-6

This clinical trial compared high-intensity laser therapy (HILT) to low-level laser therapy (LLLT) in treating plantar fasciitis symptoms.

Seventy-five patients with plantar fasciitis unresponsive to conservative treatment were enrolled in the trial. Patients were randomized to receive HILT or LLLT. Both groups completed 3 treatment sessions per week for 3 weeks.

•

HILT group: Patients received treatment with a 12 W laser. The first 3 sessions used pulsed wave therapy for 75 seconds, 8 W, 6 J/cm 2 . The following 6 sessions used continuous wave therapy for 30 seconds, 6 W, 120-150 J/cm 2 .

• LLLT group: Patients received treatment from a laser with an output power of 240 mW. Treatment was given over the tendon insertion at 0.16 W/cm 2 and over the medial border of the fascia at 0.08 W/cm 2 . Each treatment session was for 157.5 seconds.

In addition to laser therapy, both groups were instructed to wear an insole and to complete home exercises twice daily.

Patients were assessed for pain using the visual analogue scale (VAS) and Heel Tenderness Index (HTI). They were evaluated for function and quality of life using the Foot and Ankle Outcomes Score (FAOS).

After 3 weeks of treatment, both the HILT and LLLT groups showed significant improvement in all of the outcome measures. However, the HILT group improved significantly more than the LLLT group. For example, VAS scores decreased by 33.4% for the LLLT group but the HILT group scores decreased by 69%.

It can be concluded from the study that HILT and LLLT improve patient pain, function, and quality of life. However, HILT gives plantar fasciitis patients even better outcomes than LLLT.

Clinical effectiveness of multi-wavelength photobiomodulation therapy as an adjunct to extracorporeal shock wave therapy in the management of plantar fasciitis: a randomized controlled trial 42 Mary Kamal Nassif Takla and Soheir Shethata Rezk-Allah Rezk

Published in: Lasers in Medical Science, 2019 https://doi.org/10.1007/s10103-018-2632-4

This clinical trial evaluated the effectiveness of combining extracorporeal shockwave therapy (ESWT) with photobiomodulation therapy (PBMT) to treat pain and disability in patients with plantar fasciitis.

One hundred and twenty patients with plantar fasciitis for more than 6 months and unresponsive to conservative treatment were enrolled in the trial. Patients were randomized to one of the following groups:

•

ESWT: Patients in this group were treated with the Chattanooga® Intelect® Focus Shockwave. Treatment sessions were completed once a week for 3 weeks and consisted of 2000 pulses at an energy level between 0.22 and 0.28 mJ/mm 2 . PBMT: Patients in this group received photobiomodulation therapy at a dose of 2.8 J/cm 2 for 60 seconds at each session. Treatments were completed 3 times a week for 3 weeks.

• ESWT + PBMT: Treatment parameters for this group were the same as described for each of the single therapy groups. Patients received one ESWT and 3 PBMT treatments per week. Once per week, ESWT and PBMT were given consecutively with ESWT being administered prior to PBMT. • Sham PBMT: Patients in this group received

•

sham PBMT 3 times a week for 3 weeks where no power was emitted from the device.

Study outcomes included pressure pain threshold (PPT), VAS pain score, and the functional foot index disability subscale (FFI-d). The ESWT, PBMT, and ESWT + PMBT groups showed improvement in all outcome scores after 3 weeks of treatment, with further improvement at the 12 week follow-up. The ESWT + PBMT group was superior to either treatment alone in reducing pain and disability.

VAS pain scores for the ESWT + PBMT group decreased by 90.5% at the 12 week follow-up and the FFI-d scores decreased by 56.2%! In comparison, the Sham PBMT group VAS pain scores increased by 3.8% and the FFI-d scores increased by 0.6%.

The authors concluded that both ESWT and PBMT are effective treatments for reducing pain and improving function in patients with plantar fasciitis. However, combining the two treatments gives the best results.

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ABOUT ENOVIS™ Enovis™ (NYSE: ENOV) is a medical technology company focused on developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.

Powered by a culture of continuous improvement, extraordinary talent and innovation, we ‘create better together’ by partnering with healthcare professionals. Our extensive range of products, services and integrated technologies fuel active lifestyles.

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Individual results may vary. Neither Enovis, DJO, LLC or any of their subsidiaries dispense medical advice. The contents of this document do not constitute medical, legal, or any other type of professional advice. Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you. MKT-8841469757-EN – Rev A Copyright © 2025 DJO, LLC, a subsidiary of Enovis Corporation

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