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10 Articles in Volume 17, Issue #8
A Fresh Look at Opioid Antagonists in Chronic Pain Management
Addressing Chronic Pain in the United States Armed Forces
Are biosimilars as effective as their biologic counterparts?
Integrative Pain Care: When and How to Prescribe?
Lady Gaga, Fame, and Fibromyalgia
Letters to the Editor: An opportunity to learn what is on the minds of your colleagues and patients.
Must-Have Devices for Your Pain Practice
Obsessive-Compulsive Disorder & Chronic Pain
Theory of Motivated Information Management and Coping With Death
United Nations Says Untreated Pain Is “Inhumane and Cruel”

Must-Have Devices for Your Pain Practice

A review of the most popular electromedical devices, from ease of use to patient satisfaction.

The use of medical devices is becoming critically important as the healthcare industry stands at a crossroads of change. A renewed focus on chronic pain and how to best treat these costly conditions has brought medical device technology, specifically electromedical therapies, into the discussion. These alternative treatment strategies are further being considered as the paradigm shifts from fee-for-service to risk-sharing and risk-based contracting. This electromedical device review serves as an update of a previously published report that appeared in Practical Pain Management.

As healthcare reform moves forward, there will be an increased tendency to use large data sets, or big data, to gather intelligence from across a diverse set of clinical environments. As the industry shifts from volume to value, organizations will look toward leveraging flexible analytics to help manage population risk across care settings. The point of gathering and analyzing data is to then generate action-driving insights.

As medical device technology evolves, patients will have more non-pharmacologic approaches to help control their pain.

Approach

The approach to the analysis presented herein is to compare the outcomes of patients, within certain diagnostic categories, using a device with the outcomes of similar patients not using a device. For this exercise, the readers should consider these measures as crude indicators of association between the use of a device and a favorable outcome. In the near future, it is hoped that the analytics presented herein will stratify the patient population to help reduce sampling bias. In addition, it may help to identify subgroups who respond optimally to a certain treatment pathway or intervention, including the various elements that comprise an episode of care, such as specific electromedical devices.

As care and reimbursement models change to prioritize value (performance metrics versus service intensiveness), new medical device technology will play a key role in this transformation. Patient experience and throughput, cost, organizational flow, treatment effectiveness and a myriad of critical clinical, operational, financial- and patient-centered data can be made available using machine learning algorithms. The use or non-use of medical devices, such as those described herein can, and will, affect all of these medical economic aspects.

Rating & Selection Criteria

As part of this update, the author has attempted to substantiate the technology selections using the literature, practical experience, and an estimated odds ratio (OR) statistic. The OR has been applied where possible to the devices herein. The OR should be considered a crude measure of effectiveness in correlating the application of a medical device to a final endpoint, or outcome. In other words, the OR is a measure of association between exposure (medical device) and outcome (clinical end-point). The medical device becomes the predictor variable and the clinical end-point is the outcome variable.

The OR is defined herein as the ratio of probabilities [ie, probability of success in achieving selected end-point(s) over the probability of failure to achieve the selected end-point(s)]. The data repository utilized consists of just under 7,000 rehabilitation patients (approximately 140,000 patient visits) treated between the years 2008 and 2017.

The author is uniquely positioned to conduct this type of analysis as his facility conducts clinical research within the context of patient care; the clinic can include or withhold a particular therapy in patients. Beyond simply evaluating the effect of a medical device intervention on a particular patient with a specific target condition, the author understands the greater need to compare the effects of multiple devices and interventions (ie, comparative effectiveness research), which will provide important insights into which devices work best for a specific condition.

The selections herein are not rank-ordered; they represent what is considered best in brand within a certain device category. The rationale behind the choices was influenced by a combination of factors, including the availability of research and of the device for review through formal testing and informal personal experience.

For those reasons, the following products may not necessarily be “the best,” but they do demonstrate safety and clinical effectiveness, as well as high patient satisfaction. Practitioners are encouraged to explore and compare the various technologies to find which may “fit” their practice setting and patient population.

 

1. Extracorporeal Shockwave Therapy

Extracorporeal shockwave therapy (ESWT), also known as acoustic compressions, myotripsy, or shockwave therapy, has rapidly become the gold standard for the treatment of chronic, calcified, internalized, and/or fibrotic tissue stemming from longstanding trauma. The etiology of the traumatic injury can vary from repetitive strain to acute, forceful injury. In fact, the more consolidated the tissue, the greater the therapeutic target for shockwave treatments. For this reason, above-average results are typically obtained in enthesopathic conditions or where fibrotic scarring is confirmed.

Strength & Ease of Treatment

ESWT must be applied by the provider in the delivery of the focused soundwaves emitted from the probe. There is no mistaking when this device is “on”; one merely has to pass over abnormal or disorganized tissue for it to be felt by the patient. For example, application of ESWT along active trigger points or a calcified tendon, such as in calcific supraspinatus tendonitis where the increased stiffness of the lesion causes the mechanical waves to collide with the target lesion, can lead to painful pressure sensations felt by the patient. One particular device, the PiezoWave by Richard Wolf GmbH (Knittlingen, Germany), has a sono-isolation mode that allows the therapist to routinely scan over normal or healthy soft tissue with no sensations felt until an area of dysfunction (disorganization) is encountered, at which point, nociception is described as a deep achy sensation.1

The ESWT units tested and used clinically have been relatively simple to use. Frequency, intensity, and selection of stand-off pads are the primary decision points to be made.

Patient Adherence

Duality or interplay between possible clinical benefits can be weighed against the risk of “aggravating” the target condition when using this method. With ESWT, a shared decision-making paradigm, where the patient ultimately decides whether to proceed or not, may be best. Generally, the patients referred for shockwave therapy have chronic pain. For that reason, they tend to be tired and frustrated with their pain and are often willing to do what they have to do for some pain relief. ESWT has a higher probability than most other treatments when it comes to patient complaints of post-treatment discomfort.2

This expected and physiologically important discomfort may, however, signal initiation of the acute phase of healing. Despite intensive pre-treatment patient education, users should expect a higher rate of patient soreness after using ESWT. The concurrent use of ice or non-steroidal anti-inflammatory drugs after ESWT treatment is contraindicated.

Cost-Effectiveness

Shockwave devices can cost between $20,000-$30,000, making them a serious capital investment and financial obstacle to many practices. The largest prospective markets for ESWT, therefore, are physical therapy (PT) and chiropractic practices. PT professionals, for example, are typically paid by insurance companies. Given that there is no specific active (payable) current procedural terminology (CPT) code for ESWT, however, it is a difficult to argue that this provider class would benefit from purchasing the technology without a viable reimbursement option. The chiropractic profession is arguably more adept at private pay scenarios and may find this technology particularly enticing given the cost-effectiveness.

Research Base

ESWT, which emerged in the early 2000s and was adopted early on by the podiatry sector, has a multi-disciplinary appeal.3 As a result, the therapy has a relatively robust and varied research base with numerous clinical trials on record (>250). The OR is 2.8.

2. Pulsed Electro-Magnetic Fields

Patients have a contrasting sensation experience to ESWT when using pulsed electromagnetic fields (PEMFs). Typical applications are for migraine head pain and non-healing bone fracture(s); others have used PEMF for soft-tissue pathologies ranging in severity, chronicity, and complexity. The user-friendly modality does not usually involve direct provider-patient (attended) time other than set up. However, the author believes PEMF manufacturers should find a way to get this technology into the hands of clinicians in the outpatient sector to treat patients. In fact, PEMF is poised to become a device technology leader, but will only do so if providers, payers, and patients are familiar with PEMF benefits. Additional comparative effectiveness research is needed for this therapy, as with many of the other devices described herein.

Strength & Ease of Treatment

The clinical expectation when using PEMFs is that the patient will experience some sort of post-treatment reaction. The worst potential response is no response at all; is the author s belief that if we can’t make a condition worse, we probably can’t make it better either. Patients who are recalcitrant to the various forms of physical therapeutics tend not to be responsive to many other medical options, as well so non-responsiveness is not an encouraging sign.4

The application and set up for PEMFs that use the C-arm (ring) method are user-friendly and accompanied by an uncomplicated set of options for controlling intensity, frequency, and so forth. Devices with a single flat, inflexible treatment pad, however, can be slightly more problematic depending on the body area being treated and patient positioning.

Patient Adherence

Patient adherence is typically tied to several factors, including perceived benefit, costs, side effects, and convenience. PEMF treatments tend to perform well in this category as treatments are delivered in a streamlined manner and are not associated with significant adverse effects.

Cost Effectiveness

The clinical units tested were not inexpensive, ranging from $6,000 to just under $30,000. More affordable home units, including magnets and home EMF units, however, do not seem to offer the same therapeutic benefits as clinical units. Effectiveness appears to be tied into the energetics of the device.

Research Base

Although not available across the open market, this device category has made the largest leap of all devices reviewed herein based on the quality of existing research and the amount of new research in the pipeline. Regenesis Biomedical (RBI, Scottsdale, AZ), for example, has invested heavily in PEMF research and development.5 The author tested RBI’s Provant, an FDA-approved device for post-surgical pain and inflammation, across the pain therapy spectrum and found it to be effective for a multitude of conditions mediated by inflammation. The OR for this device is 3.3.

3. Low-Level Laser Therapy (LLLT)

Practitioners using cold laser treatments may be pleased to see a number of commonly available class IV units entering the marketplace. Class IV units can be felt or sensed by the patient as they generate significant heat in the irradiated region. With more power capabilities come shorter treatment times and a new dynamic in photobiological approaches. The greater energy capabilities, measured in total energy per session per area (energy density), and power densities demand a new set of data. It is still not clear whether biomodulation occurs with thermal lasers (FDA Class IV) but greater thermo-mechanical effects appear to be present.

Difficulty in gauging effectiveness with low-level laser therapy (LLLT) lies in the lack of a dose-response curve for photobiology. The speed in which we deliver a treatment and the total energy exposures involved can change from Class I to Class IV devices, hence, the need for solid in vivo and in vitro studies, followed by clinical trials that focus on outcomes.

Strength & Ease of Treatment

Unlike Class 3b LLLT treatments where there is no perceived tissue sensation during application, the class IV lasers produce heat that can be felt. The intensity of the beam is the rate-limiting factor for patient tolerance. The heating, in itself, devoid of the accompanying physiology, can have a greater belief and expectation component with patients, which could contribute to the perception of treatment benefit and/or risk. With more power, comes more risk and possible benefit necessitating more patient pre-treatment education. Class IV devices have not been shown to be more therapeutic than Class I-3 devices or any other FDA safety classification for that matter. FDA classifications refer to the safety parameters of a device and not the effectiveness or peak power of a device.

Current practice acknowledges that there can be subtle changes in the way energy is delivered to the body that can determine effectiveness, and more is not always better. The Multi-Radiance Medical (Solon, OH) laser is a Class IM device that uses a super-pulsed emission pattern to achieve superior LLLT results through photo-biomodulation (light-tissue interaction). This device is reported to have combined safety and efficacy with the safety classification of FDA Class 1M and uses super pulsing technology to create a high photonic (light energy) environment to maximize healing.

Laser devices that come with pre-programmed, built-in, condition-specific dosimetry remove the burden from practitioners of calculating energy dosages and, therefore, make this therapy easier to administer.

Patient Adherence

Patient adherence to LLLT, in the author’s experience, has been positive. In those centers that charge an extra fee for the treatment, patients experiencing a marginal benefit tend to drop out after just a few sessions. Overall patient experience seems to align with the perceived value of the session.

Cost-effectiveness

Low-level laser systems cost between $4,000-$20,000. Here, we have a situation whereby a technology with seemingly promising properties and some exciting healing potential is positioned in front of physical medicine and rehabilitation practitioners at a relatively high price point. If a provider can get past the cost of an LLLT system, then the challenge of reimbursement begins.

Caution needs to be exercised when billing for LLLT services as auditors have routinely requested re-payments on cold laser treatments erroneously billed out using the infra-red (IR) code. If one reads the CPT descriptor for proper use of this code, it defines IR irradiation as consisting of both infra-red energy emission with simultaneous heat, with this last criteria, being critical. Cold lasers do not generate heat since they are non-thermal. The new generation of Class IV devices should more appropriately fit the CPT definition described in the American Medical Association manual.

This review has alluded to the potential effectiveness of this modality especially now that both higher power ranges and pulsing configuration options are available. The Arndt-Schulz law is a reminder that sometimes less is better. The cost for professional-grade clinical laser systems continues to be prohibitive for too many practitioners. Greater market penetration would be expected with significant price reductions—not unlike many of the products making this top-device list.

Research Base

Despite a great number of reports in the field of laser therapy,6 this technology continues to have its detractors and skeptics, partly due to the way the devices are marketed. Unique properties in energy emissions or power characteristics are often pitched, but not necessarily applicable to all devices.  In addition, LLLT research appears primarily in proprietary LLLT journals. Broader publications in the form of outcomes and comparative effectiveness are needed. The OR is 2.2 using a device not described in this report.

4. H Wave Electrotherapy

The H-Wave (Electronic Waveform Lab, Huntington Beach, CA) represents in the author’s opinion one of the best-in-class for electrotherapy devices; empirical evidence supports this preference. This technology is simple and easy to use and has positive patient response. The mechanism of action is unique in that it targets lymphatic flow and purports to increase fluid flow, thereby assisting in clearing waste and in supporting nutrient/waste flow to tissues, including oxygen.7 H-Wave represents somewhat of a paradigm shift in terms of the industry views electrotherapy.

Strength & Ease of Treatment

The author’s practice has had success at treating a wide range of conditions with H Wave Electrotherapy, including tendinopathies, arthropathy, and myofascial pains with virtually no reported adverse effects. Some patients insist on having a home unit, which can be arranged depending on the insurance carrier.

The device is user-friendly and does not require extensive in-service. The user simply chooses from two frequency settings and adjusts for intensity based on patient comfort. This treatment is unassisted and does not require the provider administration beyond patient set-up.

Patient Adherence

In the author’s practice, patient acceptance of H Wave therapy is typically above average, especially as treatment success builds over time.

Cost-Effectiveness

The H Wave price point is just under $4,000 for a clinical unit, and a few hundred dollars less for the home units.

Research Base

This proprietary form of electro-stimulation has some interesting publications through various academic sources, including independent groups not associated with the product or company. The number of methodologically sound studies exceeds that of many older and more mature devices still in the marketplace today. With comparative effectiveness research needed, each clinician’s personal trial with this technology will determine perceived effectiveness and utility. The OR for this device is 2.2.

5. Shortwave Diathermy

When a deep heating effect is the desired physiological goal, shortwave diathermy (SWD) may be the logical choice for treatment. Since the 1940s, SWD has been a part of a standard physical therapy service delivery and one of the most popular forms of high-frequency electro-magnetic radiation. Included in this category of diathermy are ultrasound and microwaves, both of which have their own specific medical/surgical and rehabilitative applications. SWD is known to significantly increase temperature of deep soft tissues by increasing metabolic activity of collagen-based structures. The 1990s saw an enormous decline in the use of SWD with fewer commercially available units being sold. With more recent research focusing on tissue oxygen saturation levels as being a critical indicator of tissue viability and an important predictor of optimal function, devices that effectively increase tissue perfusion and O2 levels are likely to be in demand.

Strength & Ease of Treatment

SWD requires a great deal of precautionary care and awareness of contraindications. These high-energy sessions can cause tissue burns if careful attention to dosimetry is not monitored

There are some newer SWD configurations available in the application of diathermy as the first and second generation units have been described among users as cumbersome, with large plastic/metal electrode pads attached to swinging arms. Contemporary units are much safer and user-friendly.

Patient Adherence

It is the author’s experience that well-selected patients tend to stay with this method of therapy and complete the course of treatment.

Cost-effectiveness

Diathermy units generally cost under $10,000. Cost-effectiveness may vary based on practice type and other factors. Deep heating sessions tend to work well, for example, with more senior populations who often report more chronic conditions, such as tendinopathy and arthropathies.

Research Base

New research support for SWD is needed. Reported literature, including clinical trials, goes back 20 years. Empirical or observational evidence, however, is vast, supporting excellent potential for improving perfusion and blood flow in a target area.8

6. Infra-red Phototherapy

The use of infra-red (IR) light as a healing treatment for skin related problems, such as acne and diabetic neuropathy, has become popular in clinical settings. Arguably the most popular device in the marketplace is the Anodyne system (Anodyne Corporation, Quincy, MA), which seeks to ameliorate the diabetic condition of foot numbness/paresthesia (neuropathy) as a primary target. This company boasts more than 18 studies related to the product and has a global customer base.

The primary difference between laser and IR therapy is coherence, but there are other differences as well depending on the products being compared. IR devices come with a variety of forms and features that affect parameters, such as the number of wavelengths emitted (spectral bandwidth). Lasers tend to be monochromatic (single wavelength) whereas light-emitting diodes (LEDs) can be multi-chromatic, offering emissions at various wavelengths to create a broader treatment effect. Phototherapy devices overall emit at different wavelengths depending on the primary physiological goal.

Near-IR (632nm) devices emit a visible red beam and can be used for skin lesions and superficial pain/inflammation disorders. The far-IR devices (800-940nm range) provide deeper penetration. In the author’s experience, two species of IR phototherapy are of particular use: LED phototherapy, such as that used by Dynatronics (Dynatronics Corporation, Salt Lake City, Utah) with flexible twin pads that can be comfortably applied to a painful area such as a foot with diabetic neuropathy. The LED emission increases blood perfusion in the area which helps in re-establishing peripheral nerve sensitivity. It is recommended that any patient experiencing painful foot burning, tingling, and numbness at least try this form of treatment prior to more invasive and risky procedures.9

The second form of IR therapy found to be very useful is the Nanobeam 940 (DavaRay Corp, Mount Dora, FL), a hand-held device that emits in the 940nm range and distinguishes itself from an engineering standpoint as a device that can comfortably deliver more energy per defined area. This device is manufactured in such a manner that it deflects excessive heat build-up that inevitably occurs at greater power levels and can become the rate-limiting step in an effective treatment regimen. The Nanobeam 940 is designed to deflect heat, allowing more healing energy to be delivered to the target area.

Strength & Ease of Treatment

Phototherapy can be delivered in many forms, making it is difficult to assign a score that is representative of all devices. Generally, a treatment session is rather mild from a sensation standpoint, however, patients can feel the after-effects a few hours later. The treatment effect can be powerful among well-selected patients. Using this technology on a long-standing diabetic patient who has become unresponsive to most other treatment and for whom amputation becomes a consideration, this therapy option may be a top choice.

LED devices do require set-up time and infection control precautions. The Nanobeam 940 is used in a manner similar to a hand-held device, such as a laser, with convenient touch-button display and hand-piece control.

Patient Adherence

In the author’s experience, patients presenting with non-healing diabetic ulcerations/lesions tend to become compliant with this therapy when they observe improvements in their condition.

Cost-Effectiveness

It is important to consider that third-party reimbursement for IR therapy is dismal to non-existent among insurance carriers. Many carriers choose to label IR as investigational, often leaving reimbursement in limbo.

Research Base

Research supporting the use of IR therapy for various conditions is evident in numerous forms. The OR for this device is 1.3. The chosen end-point for calculating effect size was a 3-point decrease in VAS score and was arguably more difficult to achieve in a population consisting of chronic non-healing wounds. It can be argued that pain decreases are not achieved equally across clinical conditions, hence the possible reason for the lower OR score.

Conclusion

It is hoped that this review of contemporary electro-medical therapies may be helpful to readers searching for conservative techniques in the treatment of pain. This medical device summary is not intended to endorse or recommend one brand over another. The OR calculations have several sources of variation; for instance, the devices were used within the context of a therapy visit which usually involves multiple interventions performed simultaneously and provided by different practitioners over time.

The author’s work is not comparative in nature, so the OR of one device cannot be compared to the OR of another device. Rather, the magnitude of the OR is a combination of both device effectiveness and measurement error.

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