Theralase End of Quarter Sale of Therapeutic Lasers

Low Level Laser Therapy Class 3b vs Class 4

Low Level Laser Therapy (LLLT) is a fast growing field of medicine recognized by every major industrialized nation in the world, offering painless, non-invasive and highly effective drug-free solutions. Able to treat a plethora of neural muscular skeletal conditions, LLLT is often the only solution that is available to the highly trained practitioner to control disease when conventional therapies have come up lacking.

Unfortunately, LLLT is yet to achieve universal recognition by the medical community due to the confusion in the marketplace caused by the many poorly designed clinical studies in the published literature promulgated by researchers who lack the formal training in the rigors of proper scientific and clinical study methodologies. These unscientific and poorly designed clinical studies do more harm than good for the LLLT field, as the large number of patients who could substantially benefit from this modern miracle called LLLT are denied the service because their attending practitioners remain unconvinced of the technology. I have used many different laser devices over the past 20 years in my career and I must say that no two lasers are created equal. The best therapeutic laser I have used is one from one of the oldest and most respected cold laser manufacturers in the world; namely, Theralase Inc., based out of Toronto, Canada. The Theralase TLC-1000 laser system is Health Canada, FDA and European Union approved as a class 3B superpulsed therapeutic medical laser device. The Theralase’s advanced LLLT proprietary technology encompasses potent and complementary bioregulatory mechanisms achieved using visible red 660 nm and near infrared superpulsed (NIR) 905 nm laser light.

The Theralase superpulsed laser has the distinction of being one of the fastest in the world - delivering pulses at 200 billionths of a second, producing average powers of 100 mW and peak powers up to 50,000 mW per diode. These unique parameters result in a higher concentration of light energy (I₀), or photon density at tissue depth versus any known competitive technology, without the risk of burning tissue.

While continuous wave (CW) and standard pulsed lasers (PW) are limited to less than 1 to 2 cm of therapeutically effective depth of penetration, the Theralase superpulsed (SP) NIR laser technology is able to demonstrate therapeutic effect at up to 10 cm below the tissue surface. This allows Theralase’s superpulsed technology to target deep tissue structures such as: bones, tendons, ligaments and cartilage. In the literature, Theralase’s 905 nm superpulsed technology has been proven to be more effective than a 905 nm CW laser treatment1, thus it is the superpulsing of the Theralase technology which creates this difference.

In conjunction with its 905 nm superpulsed technology, Theralase combines 660 nm continuous wave technology leading to a synergistic therapeutic effect operating via direct photochemical and photophysical cellular events. The therapeutic optical windows of 660 nm and 905 nm laser light utilised by Theralase’s LLLT technology correspond with the absorption and the action spectra optical windows of the key mitochondria chromophores, such as cytochrome c oxidase and the cellular membrane lipids. Moreover, it is apparent that 660 nm and 905 nm light have an impact on the mitochondrial chromophores via independent and nitric oxide mediated photochemical and photophysical mechanisms.1,2,3 Hence the combination of 660 nm and 905 nm light is  proven to have an additive biologic effect compared to any individual wavelengths. This biologic effect is further amplified by these two wavelengths activating and targeting the proximal and distal therapeutic mechanisms, in tissues, which induce bioregulatory responses that effectively modulate local and systemic pathologic manifestations in the Theralase LLLT treated patients.

According to Brown et al., mitochondria produce and consume nitric oxide (NO) and NO stimulates mitochondrial biogenesis, apparently via the upregulation of nucleotides like ATP and transcriptional factors like nuclear factor kappa B (Nf-kB).⁽⁴⁾

Therefore, it can be strongly suggested that the Theralase LLLT induced NO can reprogram cellular function, mainly via oxidative stress and changes of mitochondrial temperature gradient due to a process similar to selective photothermolysis, and thus initiate a cascade of local and systemic therapeutic signalling1. These signal transduction pathways may lead to increased cell activation and traffic, modulation of regulatory cytokines, growth factors and inflammatory mediators and expression of protective anti-apoptotic proteins.⁽⁵⁾⁽⁶⁾

The results of these molecular and cellular changes in animals and humans integrate such benefits as: increased healing in chronic wounds, improvements in sports injuries and carpal tunnel syndrome, pain reduction in arthritis and neuropathies, amelioration of damage after heart attacks, strokes or nerve injury and alleviation of chronic inflammation and toxicity.⁽⁷⁾⁽⁹⁾

There is certainly more than one reaction involved in the primary mechanisms of LLLT and there is reason to believe that all of these processes occur simultaneously when a tissue is irradiated. Experimental data clearly supports the use of 660 nm and 905 nm laser light as the best choices, based on their role in the modulation of redox mitochondrial function, changes in the properties of terminal enzymes and the cellular signalling that are critical steps in the bioregulatory mechanisms of LLLT.

In closing, I must report that there is a perplexity in the literature pertaining to the direct photoacceptor or the light absorbing chromophore for near infrared light (NIR). Manufacturer’s marketing materials are particularly rich with assumptions about the prime molecular photoacceptor and mechanisms of the light within the 800 to 880 nm range; however, the clinical literature shows no strong evidence that cytochrome c oxidase has strong absorption in the 800 to 880 nm range. Therefore, although photobiological effects in the 800 to 880 light range are ascribed to light absorption by mitochondrial cytochrome c oxidase, the low absorbance in this region makes scientists highly question it.⁽⁷⁾⁽⁹⁾

Class 3B versus Class 4 Lasers

There is a slew of false information in the public domain regarding the effectiveness and cellular mechanisms activated during class 4 laser light irradiation. Many class 4 laser manufacturers are intentionally or unintentionally misleading healthcare practitioners into believing that higher power and longer near infrared wavelengths equate to deeper tissue penetration and better clinical efficacy. Nothing could be further from the truth. Particularly disturbing are claims made by manufacturers of Class 4 laser technologies emitting in the 808, 880, 970 and 980 nm wavelengths.

Unfortunately, all of these claims turn out to be fancy sales gimmicks, as they have not the standing in the clinical or scientific journals to support their claims. The clinical and scientific facts are clear that because of the very high absorption of NIR laser light by water at wavelengths greater than 950 nm, 99% of the  energy produced at this wavelength or above is absorbed before penetrating the dermis of the skin, leading to a high risk of thermal damage and a low depth of penetration. Promoting that a laser is a class 4 laser states absolutely no information about the wavelength of the device, but simply informs the purchaser about the risk of thermal tissue damage. A CO2 laser (wavelength = 10,600 nm), for example, is a common class 4 laser that is absorbed in the first 10 microns (0.0004 inches) of tissue, thus primarily in the epidermis. The same holds for the excimer (XeCl, wavelength = 308 nm) laser which is also absorbed in the epidermis. At 970 and 980 nm, the depth of penetration is less than 300 microns (< 0.01 inches), thus total absorption is achieved within the dermis of the skin. For any given wavelength, the tissue properties are determined by the scattering and absorption coefficients of the specific tissue structures resident in the tissue. These scattering and absorption coefficients determine the penetration depths and ultimately govern the overall depth of penetration of a laser beam. Now a Class 4 laser typically has higher incident power and larger treatment area, but the depth of penetration is superficial and is restricted to a few hundred microns at best (i.e.: the top layer of the dermis). Even with higher incident powers and large treatment areas there is no biochemical effect due to lack of cellular mechanism activation; therefore, the thermal effects of a class 4 laser are the only mechanism of action remaining. Once the thermal effects of tissue have been exceeded, tissue damage is imminent.

Certain manufacturers use the limited knowledge of their customers to claim that a Class 4 laser has greater efficacy than a class 3B laser. This is unsubstantiated rubbish. Laser classification is only used according to IEC-825 guidelines to determine the possible risk for eye and skin damage and has nothing to do with the efficiency in treatment.  Laser classification is determined by not just a question of optical output power, but also wavelength, divergence of the beam, emission area, pulsing parameters, exposure rates, et cetera. Regarding Class 4 high power lasers, it has not been proven in the scientific and clinical literature that high power is better than low power, in fact the opposite has been proven to be true. As I have mentioned above, there is a therapeutic “optical” response window between 600 and 950 nm and a biphasic dose response curve governed by the Arndt-Schulz law, within which the positive bioregulatory effects occur.

The use of LLLT in animals and humans almost exclusively involves light in the range above 600 nm and below 950 nm with the maximum effective “optical window” ranging from 650 nm to 930 nm.⁽¹⁰⁾

As an example, a class 4 laser emitting 880 and 970 nm laser light at 10 W average power with a beam surface area of 10 cm² producing a radiant exposure of 1000 mW / cm², thus exceeding the safe exposure limits known as the Maximum Permissible Exposure limits (“MPE”), which range from 200 mW to 500 mW / cm² depending on wavelength. Therefore, these devices need to be treated as thermal invasive devices, period!

The use of class 4 lasers have a high potential of delivering non optimal treatment doses of energy due to their lack of penetration and excessive MPE; thus presenting a greater risk  of burning patients, particularly with dark hair follicles. Let’s say that you wish to deliver energy to a tissue surface of 1 cm² with a dose of 10 joules/cm² of energy. With a 10 Watt laser this takes one second of treatment time. If however you wished to deliver 2 to 4 joules of energy to the same surface area, which is a more common therapeutic dose, this would take 0.2 to 0.4 seconds. Most Class 4 manufacturers treat up to 5 minutes with their technology, thus they have exceeded the therapeutic dose of tissue not only in wavelength by being outside the optical window, but also in power by exceeding the MPE by 20 times and the therapeutic dose by 500 times. This logic suggests that too much power and the wrong wavelength simply equates to the expense of more money without the requisite return in better clinical effects. I therefore regard lasers with output powers exceeding 500 mW as unnecessarily strong and downright dangerous to conduct LLLT treatments.

Class 4 lasers for phototherapy is not new and not innovative, as such lasers have been on the market for years but have been approved strictly for surgical applications; such as: general surgery and tissue ablation for port wine stains, spider veins, et cetera. Just advertising the advantage that a laser is class 4 and hence, is a better instrument then a class 3B laser is akin to claiming that the Chrysler 600 is a better vehicle than the Mercedes Benz 500, just because the number is higher.

The above criticism is directed towards the gross generalizations and false claims of vendors of Class 4 lasers who purport their use for therapeutic purposes, not against the use of class 4 lasers for their eligible claims in laser surgery and tissue ablation. One thing remains certain, current scientific and clinical research proves that class 3B lasers are best suited for therapeutic applications and class 4 lasers are best suited for tissue destruction.

Dr. Arkady Mandel, MD, Ph.D., D.Sc.

Bibliography:

1) In vivo effects of low level laser therapy on inducible nitric oxide synthase. Moriyama Y,   Nguyen J, Akens M, Moriyama EH, Lilge L. 3, March 2009, Lasers Surg Med, Vol. 41, pp. 227 -231)

2) Primary and secondary mechanisms of action of visible to near-IR radiation on cells. T, Karu.  1, Mar 1999, Photochem Photobiol, Vol. 49, pp. 1-17

3) Mechanisms of Low Level Light Therapy, T.N, Hamblin M.R and Demidova. [ed.] SPIE. 2006. Vol. 614001

4) Nitric oxide and mitochondria. GC. Brown. 12, Jan 2007, Front Biosci, Vol. 1, pp. 1024-1033

5) Novel effects of nitric oxide. Davis KL, Martin E, Turko IV, Murad F. 2001, Annu Rev Pharmacol Toxicol, Vol. 41, pp. 203-236

For more information, please visit www.theralase.com or call 1-416-699-5273

Theralase Opens New Head Office and Therapeutic Laser Centre

Toronto, ON – May 28, 2013 - Theralase Technologies Inc. (TSX-V: TLT), announced today the launch of its new head office and multidisciplinary therapeutic laser centre in the heart of the Beach District of Toronto, Ontario. The new laser centre will provide local patients with a proven, highly effective, non-invasive treatment to address painful and inflamed medical conditions, without the need for surgery or pharmaceutical drugs, and their associated side effects. 

“The Centre will be a multidisciplinary pain and rehabilitation treatment centre focused on delivering Theralase therapeutic laser therapy treatments through mainstream medical practitioners, such as: medical doctors, chiropractors, physical therapists, naturopathic doctors, doctors of podiatry and registered massage therapists,” said Dr. Rhonda Mostyn, Clinic Director of Theralase Therapeutic Laser Centre.  “Our initial focus will be primarily chronic and acute pain caused by neural muscular skeletal conditions, sports injuries, motor vehicle accidents or trauma, but as the centre grows, we may branch out into other disciplines such as wound healing and addiction.”

“With regards to our growing number of customers, the new training facility will provide state of the art conferencing technology and training sessions on our cutting-edge technology, laser therapy certification courses and the latest treatment protocol optimization support,” said Roger Dumoulin White, President and CEO of Theralase Technologies. “The new corporate head office, in addition to housing executive management, finance, sales and marketing functions will also support an ISO-13485 certified, Health Canada, FDA and CE approved facility to manufacture the Theralase line of therapeutic lasers, as well as aftermarket sales and service support for all of Theralase’s healthcare customers. Thousands of satisfied healthcare practitioners and patients throughout North America attest to the safety and effectiveness of Theralase’s laser technology. We expect the laser centre to be very successful in the near term adding a significant revenue stream to the Company.”

The corporate head office and therapeutic laser centre will now be located at, 1945 Queen Street East, Toronto, Ontario, Canada, M4L 1H7, Phone: 416-699-LASE (5273), Toll-free: 1-866-843-LASE (5273), Fax: 416-699-5250, and will be open from 7:00 am to 7:00 pm 7 days a week to fully service our local patients and our international sales team.

About Theralase Technologies Inc.:

Theralase Technologies Inc., founded in 1995, designs, develops, manufactures and markets patented, superpulsed laser technology utilized in biostimulation and biodestruction applications. Theralase technology is safe and effective in treating pain, inflammation and for tissue regeneration of neuro musculoskeletal conditions and wound healing. Theralase is currently developing proprietary Photo Dynamic Compounds (PDCs) that are able to target and destroy cancers, bacteria and viruses when light activated by Theralase’s proprietary and patented laser technology.

 For further information please visit www.theralase.com , regulatory filings may be viewed by visiting www.sedar.com.

 

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.

For More Information:

Roger Dumoulin-White                                                                     

President & CEO                    

416-699-LASE (5273) ext. 225                                   

rwhite@theralase.com 

Low Level Laser in the Treatment of Migraine and Traumatic Brain Injury in the Adult population

Pratibha Bansal M.D.,   Romanth Waghmarae M.D. DABA, FIPP. , Louis Banas B.S. , M.S. CLT ; Buffalo, New York,  June 2012

Note: Dr’s Bansal and Waghmarae are Board Certified Pain Management Physicians who have practicing Pain Management in Buffalo, New York for over 20 years.   Louis Banas is a laser specialist who has treated over 2500 hundred patients for chronic pain issues. He has treated over 60 adults for headaches of various types with significant success in most cases.   

Abstract:

Migraine headache due to trauma or otherwise is a major health concern worldwide with massive financial and social impact. Conventional treatments primarily focus on the prevention of further damage to the brain parenchyma, while failing to address the already existent symptoms. Previous clinical studies have shown that Low Level Laser Therapy (LLLT) can significantly reduce pain and induce temporary vasodilation in capillaries.  The authors demonstrate how LLLT can be used to improve the quality of life in patients by treating their current symptoms,. This case report illustrates the use of LLLT in the treatment of several patients with a severe headache and the clinical success achieved in the reduction of pain, as measured by VAS - achievable within 2-8 treatments.

Abstract:

Objective Information and Background.

The following case studies were followed at a Pain Management Clinic in Buffalo New York.  Pain Rehab is staffed with two board certified Pain Management Specialists who will see 300 to 400 patients weekly. Most patients were being seen do to traumatic injuries suffered at work, home or auto accident and in most cases had little or no relief with physical therapy, chiropractic, massage or surgery. Pain Rehab is very progressive in utilizing new and proven technology and reluctantly prescribes opiates and NSAIDS . All patients suffered from moderate to severe, debilitating pain on a daily basis. After a very positive evaluation of laser therapy on patients, a physical therapy clinic was added to the practice, therefore enabling this new modality to be readily available to their patients. Several patients suffering from chronic, debilitating headaches due to trauma or congenital defects were treated during a four month period. (It is important to note that headaches were just part of the overall pain complaints except for two patients noted in cases 4 and 7.) Over twenty patients were treated and only two patients out of twenty did not respond well. The treatments were performed by a laser specialist with four years of laser experience.  Listed below are a few of the significant, more interesting cases.

Case # 1.  A 28 y.o. female suffered severe whiplash in an auto injury and complained of daily, severe headaches with a vas value of 7-8 accompanied by blurred vision for a 12 month period. Laser was applied to bilateral temples and mastoid   for 2 minutes, delivering 15 joules to five sites, which included bilateral temple and mastoid sites and right cervical spine.  Patient was not able tolerate minimal cervical spine treatment. , including 6 joules per site for a 3 minute duration.  Note: Patient is African American and due to nerve damage or skin pigmentation could not tolerate prescribed dosage.   Treatment was given 3 times per week for two weeks at a reduced dosage for a total of six treatments.  Pain levels were substantially reduced and patient now only suffers 2-3 episodes per week with a vas value of 2-3.

Case #2 .  38 y.o. female, auto injury.  Previous physical therapy was unsuccessful. Patient complained of daily headaches 7-8 on the vas scale for two years.  Treatment included bilateral c-spine and right trapezium for 3 minutes time delivering 42.5 joules to each site, for a period of two weeks and levels increase to 72 joules for second week as patient healed and was more able to tolerate the procedure.  Patient received 12 treatments over a three week period and now experiences mild to moderate headaches once or twice per month.

Case 3#.  58 y.o. male was injured on the job and suffered a severe neck and left clavicle injury. Headaches were daily which were debilitating and patient reported a 7-8 level on the vas scale. Treatments of 8 sessions included 76.5 joules applied to left cervical spine and clavicle. 15 joules were applied to left cervical 1 area, after 10 treatments the headaches were entirely eliminated.

Case # 4. A 23 y.o. Female suffered from headaches 3-4 times per week since six years of age.  Patient has a high stress job as customer service representative. One treatment was applied at both temples delivering 15 joules in a two minute session. Patient was headache free for one week. 

Case#5.  A  57 y.o. female, auto injury 17 years ago and had damage to both frontal lobes. 28 Joules was applied to her forehead at two sites. Due to transportation difficulties her treatments are sporadic but after two treatments she now wakes up with minimal or no pain on most mornings.

Case #6.  A 52 y.o. male fell at work and hit back of head. Headaches occur on daily basis since accident 4 months ago.  Two treatments were performed two days apart delivering 25 joules to injured area. Patient states that headaches are significantly reduced and sleep patterns are substantially improved.

Case # 7. A 31 y.o. female former military P.A. presented herself with migraine headaches with a vas value of 7-8 on a daily basis. She has suffered with them since the age of 8.  The patient had seen several specialists including neurologists who were unable to help. The patient had military training as a physician’s assistant and realized she needed detoxing from drug overload which had been prescribed for the problem.   A single laser treatment was administered which included  48 joules at 2 sites on the forehead and 28 joules to four sites which included bilateral temple and mastoid areas.  The patient had significant relief for a 7 day period at which point she felt the change in medications was to blame. She returned for a single visit one day after the relapse and the  procedure was repeated.  The patient reported to be pain free within minutes after the procedure.  She feels she is completely healed.

Technical data:

The system utilized is the Theralase super pulsed Low Level Laser medical system. It  The system is equipped with a multiple probe hand piece (5 x 905 nm wavelength @0-100 mw average power per laser diode and 4 x 660 nm wavelength @25 mw . power per laser diode. (This allows for deep penetration of tissue when necessary with minimal heat transference to the tissue).

Healing pathways- Discussion

The majority of patients seen in this clinic have multiple injuries and headaches are a by-product of some type of trauma. Therefore, it may be safe to assume that vascular insufficiency is the main cause. A recently published a peer review paper concludes that the equipment used utilizes a 905 nm. Wavelength increasing Nitric acid up to 700 percent which expands capillary delivery of oxygenated blood. Currently Dr. Michael Whalen, working at Massachusetts General Hospital, is conducting controlled studies using a low level laser with the hopes of bringing this new technology into the forefront of neuroscience and medicine. These case studies give examples of how LLLT can be used to treat chronic migraines, specifically those that are a result of traumatic brain injuries. LLLT has been shown to reduce pain and inflammation, create a state of vasodilation by activating the nitric oxide pathway and further even promote angiogenesis.

ATP production.  Cold laser has the unique ability to generate the production of ATP Adenosine Tri-phosphate through a process called biostimualtion. Vacuoles (cytochromes and chromaphores) in the mitochondria of the cell absorb specific light wavelengths causing a cascade effect which rejuvenates damaged cells lacking this essential fuel molecule. Although this may be the main pathway for treating the traumatic injures, it is arguable that the nitric oxide production is the primary source of pain reduction.

Summary. LLLT is now becoming a valuable but slowly recognized modality for acute and chronic pain as well as wound care in the United States. It has been used extensively in Canada for over 12 years.

REFERENCES

1.            Faul M, X.L., Wald MM, Coronado VG, Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths. 2010.

2.            Finkelstein E, C.P., Miller T and associates, The Incidence and Economic Burden of Injuries in the United States. Oxford University Press, 2006.

3.            Sahni, T., et al., Use of hyperbaric oxygen in traumatic brain injury: retrospective analysis of data of 20 patients treated at a tertiary care centre. Br J Neurosurg, 2012. 26(2): p. 202-7.

4.            Naeser, M.A. and M.R. Hamblin, Potential for transcranial laser or LED therapy to treat stroke, traumatic brain injury, and neurodegenerative disease. Photomed Laser Surg, 2011. 29(7): p. 443-6.

5.            Moriyama, Y., et al., In vivo effects of low level laser therapy on inducible nitric oxide synthase. Lasers Surg Med, 2009. 41(3): p. 227-31.

6.            Wu, Q., et al., Low-level laser therapy for closed-head traumatic brain injury in mice: effect of different wavelengths. Lasers Surg Med, 2012. 44(3): p. 218-26.

7.             Stephan, W. et al . Efficacy of super –pulsed 905 nm Low Level Laser Therapy in the Management of

Traumatic Brain Injury (TBI) World Journal of Neuroscience November 2012  www.scirp.org/journal/wjnsl

For further information, please visit www.theralase.com or call 1-855-494-7246

Back Pain Is #1 Cause of Disability Worldwide

Global Burden of Disease 2010 highlights the pressing need to prevent, treat spinal and musculoskeletal disorders.

By Peter W. Crownfield, Executive Editor

A series of studies emerging from the Global Burden of Disease 2010 Project, a massive collaboration between the World Health Organization, the Institute for Health Metrics and Evaluation (the coordinating center), the University of Queensland School of Population Health, Harvard School of Public Health, Johns Hopkins Bloomberg School of Public Health, and the University of Tokyo, Imperial College London, clarifies the worldwide health burden of musculoskeletal conditions, particularly back and neck pain, in crystal-clear fashion, with low back pain identified as the number-one cause of disability worldwide and neck pain the number-four cause. Overall, musculoskeletal conditions represent the second leading cause of global disability.
Findings emphasize the shift in global health that has resulted from disability making an increasingly larger footprint on the burden of disease compared to a mere 20-30 years ago. In addition, while more people are living longer, the flip side is that they do so with an increasing risk of living with the burden of pain, disability and disease compared to generations past.
Dr. Scott Haldeman, who chaired the 2000-2010 Bone and Joint Decade Task Force on Neck Pain and Its Associated Disorders, and is currently president and CEO of World Spine Care, provided DC with an analysis of the Global Burden of Disease 2010 findings, highlighted as follows:

• Musculoskeletal conditions such as low back pain, neck pain and arthritis affect more than 1.7 billion people worldwide and have a greater impact on the health of the world population (death and disability) than HIV/AIDS, tropical diseases including malaria, the forces of war and nature, and all neurological conditions combined.
• When considering death and disability in the health equation, musculoskeletal disorders cause 21.3 percent of all years lived with disability (YLDs), second only to mental and behavioral disorders, which account for 22.7 percent of YLDs.
• Musculoskeletal conditions represent the sixth leading cause of death and disability, with only cardiovascular and circulatory diseases, neonatal diseases, neoplasms, and mental and behavorial disorders accounting for more death and disability worldwide.
• Low back pain is the most dominant musculoskeletal condition, accounting for nearly one-half of all musculoskeletal YLDs. Neck pain accounts for one-fifth of musculoskeletal YLDs.
• Low back pain is the sixth most important contributor to the global disease burden (death and disability), and has a greater impact on global health than malaria, preterm birth complications, COPD, tuberculosis, diabetes or lung cancer.
• When combined with neck pain (21st most important contributor to the global disease burden including death and disability), painful spinal disorders are second only to ischemic heart disease in terms of their impact on the global burden of disease. Spinal disorders have a greater impact than HIV/AIDS, malaria, lower respiratory infections, stroke, breast and lung cancer combined, Alzheimer's disease, diabetes, depression or traffic injuries.
• Current estimates suggest that 632.045 million people worldwide suffer from low back pain and 332.049 million people worldwide suffer from neck pain.

"The Global Burden of Disease Study provides indisputable evidence that musculoskeletal conditions are an enormous and emerging problem in all parts of the world and need to be given the same priority for policy and resources as other major conditions like cancer, mental health and cardiovascular disease," said Dr. Haldeman.
The seven studies from Global Burden of Disease 2010, as well as accompanying commentaries, appear in The Lancet.

For more information please visit www.theralase.com or call 1-855-494-7246 (PAIN)

Webinar: Cold Laser For Knee Injuries

Cold Laser For Knee Injuries

Cold Laser For Knee Injuries Date: Wednesday, December 12, 2012 Time: 1:00 PM - 2:00 PM EST Below are a few items that will be covered in the Webinar: Learn How Laser Therapy Can Heal Knee Injuries including OA, Meniscus Tears, and Patellofemoral Syndrome. Select Optimal Laser Settings to Treat Knee Joint Injuries. Review Current Research on Laser For Knee Pain. Space is limited. Reserve your Webinar seat now at: https://www2.gotomeeting.com/register/584866098 After registering you will receive a confirmation email containing information about joining the Webinar. System Requirements PC-based attendees Required: Windows® 7, Vista, XP or 2003 Server Macintosh®-based attendees Required: Mac OS® X 10.5 or newer Regards, The Theralase Team Links www.theralase.com Theralase Laser Clinic Clinic Locator

The Top Ten Features to Look For in a Cold Laser

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Clinical and Business Rewards of Using Laser in Practice

Tuesday, October 23, 2012 1:00 PM - 2:00 PM EDT

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Below are a few items that will be covered in the Webinar:
Clinical outcomes from laser treatments in Dr. Lemasurier's Practice
Increasing patient volume  and patient satisfaction
Time management - juggling modalities in practice
Advertising and marketing your laser

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Is TENS Just a Placebo for Chronic Pain?

From :Pain-Topics.org News/Research UPDATES

Recently reported research found that transcutaneous electrical nerve stimulation (TENS) was significantly helpful in reducing chronic pain intensity and disability while improving perceived health status for up to 1 year. However, these outcomes were comparable to those produced by sham/placebo TENS. Does this mean that TENS is worthless as a pain-treatment modality, or is there a need to reconsider the role and value of meaningful placebos in pain management?
TENS is an easy to use, noninvasive, analgesic intervention that may result in less pain, increased functionality, and decreased use of pain medication. Although TENS has been in use since the early 1970s, short-term results of this therapy have been inconclusive for treating chronic pain, and long-term randomized placebo-controlled studies with treatment periods of more than 3 months had not been executed. Therefore, researchers in The Netherlands designed a study to explore the long-term (1 year) time course of TENS treatment effects compared with a sham-TENS placebo [Oosterhof et al. 2012].
Writing in the September edition of Pain Practice they report a randomized placebo-controlled trial enrolling 163 patients with chronic pain who had been referred to a multidisciplinary pain center at a university hospital. Patients were being treated for peripheral neuropathic pain, osteoarthritis and related disorders, or injury of bone and soft tissue, and usual care for their conditions had failed in the past to satisfactorily ameliorate their pain.
Prior to randomization, all patients had their pain medication optimized by the attending anesthesiologist or pain practitioner; however, at baseline, the mean pain intensity among all patients was still moderate (about 62mm on a 100mm scale). Identical TENS devices were used for the actual and sham treatments, and self-applied by subjects for several hours each day. Sham units showed a fake output reading on the LCD display, but no current was delivered to the electrodes. The main endpoints of interest were the proportion of patients satisfied with treatment results and willing to continue treatment at the end of 1 year, pain intensity, pain disability, and perceived health status.
Results indicated that, throughout the time-course of the study, there was no significant difference (P=0.79) in the proportion of patients satisfied with actual vs. sham-TENS therapy; at the end of the year, an intention-to-treat analysis showed that 30% (24/81) of patients in the TENS group and 23% (19/82) of the sham-TENS group were satisfied with treatment results. These 43 patients in both groups experienced a mean overall improvement of 62.7%, and there were no significantly different between groups (P=0.74). Also, for patients still satisfied after 1 year, there were no differences in pain intensity or disability, perceived health status, or pain medication use between the TENS and sham-TENS groups; although, these measures in both groups had improved significantly from baseline.
COMMENTARY: Limitations & Possibilities
As noted above, TENS therapy has been in existence for nearly 4 decades. The TENS unit is a small, portable device delivering mild electrical current to nerves through electrodes connected to the skin at or near the sites of pain.
The approach has been used for various types of pain, although exact mechanisms of its analgesic effects are still under examination. Basic science studies suggest that TENS activates endogenous pain-control chemicals (eg, endorphins, enkephalins, dynorphins, GABA, serotonin) and their receptors. Along with that, the high and low electrical frequencies produced by a TENS unit inhibit pain signals along affected nerves, ostensibly blocking the impulses from reaching pain-perception areas in the brain.
In the Oosterhof et al. [2012] study, for those patients who appeared to respond to a TENS intervention and were satisfied with the therapy, there were stable improvements in pain and other measures over the 1-year period, whether they were assigned real or sham TENS units. However, as the authors concede, there was no third group for comparison receiving standard care without TENS to control for regression to the mean or the natural course of chronic pain, so they could not claim to have found a true placebo effect induced by the sham-TENS procedure.
During the year, 44 patients in the TENS group were lost to followup, with 18 dropping out due to dissatisfaction with treatment results. In the sham-TENS group, there were only 32 lost to followup, with 14 dissatisfied with results. Also, 93% of subjects in the actual TENS group but only 70% in the sham-TENS group believed they had received a real TENS unit, which should have decreased favorable placebo effects but did not.
The intervention was relatively safe, with the only adverse effect being that roughly half of all patients experienced skin problems caused by the electrodes, but only 4 (2 in each group) discontinued for this reason. Apparently, this was not due to actual electric current and the researchers noted that this problem can normally be overcome by changing the type of electrode.
The researchers note quite importantly that among those patients still satisfied with either actual or sham TENS after 1 year there was an average decrease of more than 50% in pain intensity, which is both statistically and clinically significant. Even among those who stopped treatment earlier, there was about a 28% improvement in pain, which may be clinically noteworthy since this went beyond the pain relief afforded them by usual medical care.
As one limitation, there may not have been a sufficient number of subjects completing the trial. The study design required 35% of patients in the TENS group and 15% in the sham-TENS group being successfully treated after 1 year to have 80% power for detecting significant difference between groups. Since these targets were not achieved, the lack of differences between groups might have been statistically a false negative, or Type II error.
Aside from that, in this long-term study by Oosterhof and colleagues [2012] it appeared that TENS might have functioned similar to placebo or, conversely, the sham/placebo treatment may have had genuine medical efficacy. As the researchers note, this may support the contention that “placebo effects are genuine psychobiological events, which can be robust in both laboratory and clinical settings.”
Along these lines, the researchers observe that, in neuropathic pain trials, placebos have had durable long-term effects that pose difficulties in distinguishing between treatment and placebo effects. Furthermore, other researchers [eg, Quessy and Rowbotham 2008] have noted that this problem is magnified in trials in which long treatment periods under blinded conditions are required and in which the analysis assigns trial dropouts as treatment failures, as in the Oosterhof et al. study.
TENS for Chronic Pain
Other research has investigated TENS for chronic pain. A Cochrane Systematic Review by Nnoaham and Kumbang [2008] compared “no treatment” controls with sham-TENS or active TENS using different electrical frequencies. Of 124 studies identified in their searches, only 25 RCTs (N=1,281) could be evaluated. At that, there was such a high degree of heterogeneity (differences and inconsistencies) across studies that a data meta-analysis was not possible.
Overall, in 13 of 22 sham/placebo controlled studies there was a positive analgesic outcome in favor of active TENS treatments. For multiple-dose treatment comparison studies, 8 of 15 were considered to be in favor of TENS therapy. Results were based on short-term low-volume TENS treatment: The duration of treatment was <4 weeks in about 80% of the studies, and in 70% of the trials treatment occurred <10 hours per week with 60% of the participants having <10 total sessions of TENS. The authors note that these limitations may explain why some of the studies failed to detect any differences between active TENS and sham controls.
Nnoaham and Kumbang conclude that published literature on TENS lacks the methodological rigor or robust reporting needed to make confident assessments of this therapy for chronic pain management. However, they assert that, even if the effect of TENS on chronic pain is a weak one, its potential to augment the effect of other pain treatment modalities should be explored. Indeed, in the much longer-term Oosterhof et al. study, TENS therapy was additive to analgesic effects of pain medications that all patients were taking.
TENS for Low-Back Pain
We have previously discussed in an UPDATE [here] evidence reviews and guidelines that found TENS ineffective for treating chronic low-back pain; although the evidence had some strong limitations that challenged its internal and external validity. Similarly, in 2008, a Cochrane Systematic Review by Khadilkar et al. examined 4 high quality RCTs of TENS for chronic back pain (585 patients) and found conflicting and inconsistent evidence, in comparison with placebo, to support the use of TENS. However, these studies were so disparate in design (clinical heterogeneity) that the researchers could not do a data meta-analysis and had to rely on qualitative observations that are prone to bias.
In response to the lack of clear and convincing evidence in support of TENS for chronic back pain, last summer the U.S. Centers for Medicare and Medicaid Services (CMS) announced it would no longer cover most uses of TENS for this pain condition [see MedPage Today article here]. They noted that reimbursement for TENS in treating low-back pain in particular will be available only when patients are participating in a randomized, controlled trial of the technology’s clinical effectiveness.
In the announcement they wrote, “TENS is not reasonable and necessary for the treatment of [chronic low back pain].” The CMS had conducted a review in the wake of a 2010 report by an American Academy of Neurology panel that, on the basis of only 5 trials, found the treatment was not effective [discussed in the abovementioned UPDATE]. Although, the CMS also acknowledged that some individual studies have shown that TENS can reduce pain and improve patients' physical function.
While the CMS plans to withhold coverage of TENS for chronic back pain, it will continue to fund RCTs of TENS for 3 years. The trials must directly address TENS’ clinical efficacy and be designed and powered to yield clear-cut answers. At present, the CMS emphasized that Medicare will still reimburse for TENS prescribed for treatment-resistant pain conditions other than low back pain, such as for chronic or severe postoperative pain.
When is a “Placebo” of Meaningful Value?
There are some interesting and remarkable parallels of research outcomes for TENS, as described above, with acupuncture for chronic pain in regard to the prominent influence of placebo effects as a possibly important component of therapeutic efficacy. Acupuncture was most recently discussed in an UPDATE [here], which noted that its benefits for treating musculoskeletal pain, osteoarthritis, and chronic headache were only weakly better than placebo, but that both placebo and true acupuncture conferred moderate benefits in reducing pain that went beyond and above the usual medical care patients had been receiving.
Both acupuncture and TENS have been available for a long time and there has been much research conducted to examine each modality; yet, the quality of most research has been surprisingly low and generally precludes an unbiased pooling of studies for more rigorous analyses. Despite this, it appears that both modalities have potential for offering select groups of patients nonpharmacologic options for pain relief and other health benefits; albeit, perhaps due largely to placebo components of the overall effects. And, as the Oosterhof et al. study demonstrates, the duration of those favorable effects can be long-lasting.
TENS is noninvasive and acupuncture is minimally invasive, both have relatively favorable safety profiles, and their benefit-to-cost ratios may be advantageous compared with some other therapies. Either therapy may be abruptly discontinued without adverse effects and, as the Oosterhof et al. study suggests, patients who do not benefit readily stop the treatment.
So, perhaps what is needed is a reconceptualization of the role of placebos in pain management and, when it comes to TENS or acupuncture, a recognition that a completely inert placebo version of these therapies may not exist.
As Andrew Avins, MD, suggested in an editorial discussed in our recent UPDATE on acupuncture, it may be time for an examination of why so many healthcare professionals feel threatened by the existence of placebo effects and, instead, consider how those effects might be harnessed for better pain care. Capitalizing on placebo effects may be perceived as bad science by some, but it may be welcomed as good medicine by patients who benefit.

Disclosure: We have no vested interests in or support from any manufacturers of electrical nerve stimulation devices, including TENS. Our only interest here is in arriving at sound practice decisions in pain management based on appropriately credible, reliable, and valid analyses of clinical evidence. — SBL

REFERENCES:
> Khadilkar A, Odebiyi DO, Brosseau L, Wells GA. Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Cochrane Database of Systematic Reviews. 2008;4(CD003008) [abstract].
> Nnoaham KE, Kumbang J. Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Cochrane Database of Systematic Reviews. 2008;3(CD003222) [abstract here].
> Oosterhof J, Wilder-Smith OH, de Boo T, et al. The Long-Term Outcome of Transcutaneous Electrical Nerve Stimulation in the Treatment for Patients with Chronic Pain: A Randomized, Placebo-Controlled Trial. Pain Practice. 2012(Sep);12(7):513-522 [abstract here].
> Quessy SN, Rowbotham MC. Placebo response in neuropathic pain trials. PAIN. 2008;138(3);479-483 [abstract here].