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“Does opioid tapering on Chronic Pain Patients (CPP) result in improved pain or the same pain vs. increased pain at taper completion? A structured evidenced based – systemic review”
Citation: D. Fishbain MD FAPA, Aditya Pulikal MD, JD Pain Medicine Dec, 2018

A recent systemic review of the available literature examined the impact on the tapering / removal of chronic opioid use by chronic pain patients (cpp) and the resulting impact on chronic pain patients (CPPs) pain. The findings were as follows:

Combining all studies, 2,109 CPPs were tapered. Eighty percent of the studies reported that by taper completion pain had improved. Of these, 81.25% demonstrated this statistically. In 15% of the studies, pain was the same by taper completion. One study reported that by taper completion, 97% of the CPPs had improved or the same pain, but CPPs had worse pain in 3%. As such, 100% of the studies supported the hypothesis. Applying the Agency for Health Care Policy and Research Levels of Evidence Guidelines to this result produced an “A” consistency rating.

There is consistent type 3 and 4 study evidence that opioid tapering in CPPs reduces pain or maintains the same level of pain. However, these studies represented lower levels of evidence and were not designed to test the hypothesis, with the evidence being marginal in quality with large amounts of missing data. These results then primarily reveal the need for controlled studies (type 2) to address this hypothesis.

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Medications, like Advil, may be better for your osteoarthritis pain than opioids.

A recent study published in the medical journal JAMA, suggested that non-opioid medications (such as anti-inflammatories, acetaminophen, pamelor capsaicin cream, gabapentin, and tramadol) are slightly more effective then opioids at treating chronic back pain and /or hip and knee pain from osteoarthritis.

The study was conducted over a 12-month period, and included a total of 240 patients with moderate to severe pain, despite pain medication use. Non-opioid medications seemed to relieve pain intensity more and had fewer bothersome side effects.  The opioids studied included morphine and hydrocodone, with the option to escalate to long-acting opioids.

Critics of the study, report concerns of patient reporting bias. Siting the negative stigma associated with Opioids as reported in the media.

Dr. Adam Hedaya has three locations in Northeast Ohio to treat your osteoarthritis.  Find your nearest location and schedule an appointment today at www.clevelandpaincare.com

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Kratom is a leaf that is closely related to the coffee tree. It is embraced by some 2-5 million pain patients who often ingest the leaves in powdered form or brew them as tea to treat pain.
There is an emerging push by the FDA to schedule Kratom as a controlled substance do to its opioid properties and the lack of evidence around its safety profile, the variability of how it’s being formulated, sold and used.
Many clinical researchers think Kratoms abuse potential is limited. Pharmacological models predict that Kratom generally binds to mu opioid receptors. However, Kratom alkaloids are potentially novel in that they activates G-protein analgesic  (pain) pathways but spares the Beta-arrestin pathway which controls breathing centers, and the cause of death from opioid overdose.
The biggest challenge appears that like with supplements, Kratom products are unregulated and that a portion of these products are adulterated with other substances.
Clearly more research and oversight is needed to better understand the risks and benefits of this plant product for patients in pain.
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The study published in the Journal of Pain showed that obese individuals that restricted calories over three to four months noticed a significant reduction in generalized pain.  The results were most impressive for those shedding at least 10% of their weight.

The thought process behind this is not well understood, but may be related to global inflammation and lower cytokine levels.  It is well established that weight loss has a positive effect on mood and energy as well.

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The use of Platelet Rich Plasma for pain associated with Interstitial Cystitis has been shown to be effective in a study of 15 women. The women were treated with repeat bladder injections (a total of 4 injections) using 12ml of autologous (patient derived) Platelet Rich Plasma.  Of the women who had an improvement in pain, there were noticeable changes to inflammatory markers and growth factors.  In addition, there were no major reported complications.
Given that Interstitial Cystitis is difficult to treat and often refractory to mainstay medical treatments, Regenerative Medicine, and PRP specifically may offer a novel and safe treatment option for women struggling with this painful and debilitating condition.
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One of the more common and traditional methods for treating pain that shoots down a leg or arm (lumbar or cervical radiculopathy) due to a herniated disc or narrowing along a spinal nerve (spinal stenosis) is the use of steroid injections into the epidural space.
Many patients benefit from this treatment and find great relief from “epidural steroid” injections.  Particularly, when medications, physical therapy, and other conservative measures fail to provide pain relief and improve functioning.  In addition, many patients are able to avoid more invasive surgeries thanks to the anesthetic and anti-inflammatory effects of the medications in these injections.
However, these injections do not always work. And for those individuals that do not find relief or have a contraindication to the use of steroids (severe osteoporosis for example) alternatives have been lacking.
A recent study demonstrated that a new technology may have emerged called “Platelet Lysate.” Platelet Lysate simply means concentrated and broken up platelets.
Platelets are cells that exist within our whole blood. These cells have healing and wound clotting properties, and are rich with anti-inflammatory enzymes and growth factors.  You may have heard of Platelet Rich Plasma or PRP.  PRP is a essentially the purification and concentration of platelets from whole blood.
To obtain Platelet Lysate. PRP is frozen and then thawed. The process of thawing the platelets breaks the platelet cells and liberates the enzymes and growth factors. The residual cellular debris of the platelets can then be removed and the pure platelet enzymes “Platelet Lysate,” can then be injected into the epidural space.  This is a clear alternative to the more traditional epidural steroid injection.
The benefit of Injecting Epidural Platelet Lysate over PRP may be several fold. PRP Injections due to their high content of inflammatory cells can be painful.  Platelets also have the potential to adhere and cluster. Lysated platelets however are potentially more anti-inflammatory and offer the possibility of less local cellular aggregation.
The results of these epidural platelet lysate injections were reported in the Journal of Experimental Orthopedics. 470 patients with leg pain were treated with Platelet Lysate epidural injections by 20 different physicians in 13 clinics nation wide. Just under 50% of the patients treated reported improvement in pain and function at 24 months after the injection.  No major complications were reported as a result of these injections.
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A sodium channel blocker that may offer a non addictive alternative to opioid painkillers is in a phase 2 study.
Vertex Pharma reported in February, that a study involving 243 patients showed promise. The study randomly assigned patients to 3 treatment groups. Those who received VX-150 (a sodium channel blocking agent), those who received hydrocodone plus acetaminophen, and those who received a placebo (a substance with no pain relieving properties).
The patients received treatment for two days following bunionectomy surgery.  The sodium channel blocking substance outperformed the placebo in alleviating pain at both 24 and 48 hours post surgery.
The VX-150 compound seemed to perform as well as the hydrocodone and acetaminophen group. Although the study was not statistically powered to make a direct comparison.
Of note, VX-150 was reportedly generally well tolerated, with no serious adverse events, and no discontinuation due to adverse events.
VX-150 has also apparently shown promise in a phase 2 trial involving patients with chronic osteoarthritis pain. The potential pharmaceutical is currently being studied for nerve related pain. Ref: Volume 53, Number 8, April 2018; Psychiatric News
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Introduction

Fibromyalgia syndrome (FMS) is a common clinical disorder of unknown etiology characterized by widespread pain and muscle tenderness often accompanied by chronic fatigue, sleep disturbance, and depressed mood. Approximately 3.4% of women in the United States suffer from FMS, 10 times the prevalence in men.

The uncertain etiology of FMS complicates a rational approach to pharmacotherapy. Several recently completed trials demonstrate promise, though not without concern for serious adverse effects. Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly utilized, despite the fact that they have been found to have negligible effectiveness, along with potential gastrointestinal and renal toxicity. In clinical trials, the atypical opioid, tramadol, has shown some promise in controlling pain with inconsistent results in functional improvement, although a combination with acetaminophen has shown promising results in a randomized trial., A recent series of treatment guidelines expresses caution in the use of tramadol for FMS due to the potential for opiate dependence. A controlled trial of prednisone resulted in no improvement; most measured variables showed a trend toward deterioration. The limited data available on the use of selective serotonin reuptake inhibitors have shown them to be less effective than the tricyclic agents. Pregabalin was found to be efficacious for FM symptoms in various doses in randomized trials lasting between 8 and 14 weeks; the initial trial resulted in the first U.S. Food and Drug Administration (FDA) approval for a drug to treat FM.Of note, the most recent trial of pregabalin excluded “placebo responders,” limiting external validity and biasing away from the null. Duloxetine, a serotonin-norepinephrine reuptake inhibitor, demonstrated efficacy in two 12-week randomized controlled trials, as well as a 6-month randomized clinical trial (RCT) on pain and self-perceived improvement. In the treatment arm with the highest dose (120 mg/d), 27.2% of patients discontinued the study due to adverse effects.Duloxetine was approved for fibromyalgia in June 2008.

Dietary interventions have demonstrated some promise; FMS symptoms decreased in patients eating predominantly raw vegetarian diets., Other open-label trials using nutritional supplementation consisting of whole food extracts, plant constituents, or single vitamins, reported an increase in pain tolerance and overall quality of life.

As is true of many conditions that are poorly understood and rather resistant to conventional treatments, FMS often compels those afflicted to seek complementary and alternative medicine (CAM)., These CAM interventions include nutritional and herbal supplements, spiritual practices, visits to alternative practitioners, dietary modifications, acupuncture, and osteopathy. While patient satisfaction with these treatments is ranked moderate to high, there currently exists limited evidence of the efficacy of any specific intervention. Several small trials have shown promise for a combination of malic acid and magnesium, and S-adenosylmethionine.,

Intravenous micronutrient therapy (IVMT), and specifically use of the “Myers’ Cocktail,” a solution of water-soluble vitamins and minerals, is a popular approach among CAM practitioners. Interest in and use of IVMT is growing as evidenced by the number of clinics across the United States offering IVMT as a principal treatment. Members from a wide range of national medical associations including The American College for Advancement in Medicine (ACAM), The American Association of Naturopathic Physicians, the American Holistic Medical Association, the American Academy of Pain Management, the Great Lakes College of Clinical Medicine, and the International Society of Orthomolecular Medicine (ISOM) report using IVMT. Data from over 12,000 patient encounters obtained by an online survey of members of these organizations suggest that IVMT is widely used for a variety of conditions, most often FMS and chronic fatigue syndrome, with consistently positive results. Despite its popularity, no controlled trials of IVMT, and only one trial investigating the mechanism of action of the Myers’ Cocktail have been conducted. A single, small-sample, open-label study of the Myers’ cocktail for FMS was recently published suggesting therapeutic efficacy.We therefore performed the first controlled clinical trial of IVMT for FMS.

Methods
Participants

The Yale University (New Haven, CT) Human Investigation Committee and Griffin Hospital (Derby, CT) Institutional Review Board approved the protocol. All enrolled participants provided informed consent.

Eligible subjects were English-speaking between 18 and 75 years old who fulfilled the criteria for FMS, as defined by the American College of Rheumatology, namely: (1) continuous presence of widespread (in all four quadrants of the body, including axial) musculoskeletal pain of undefined etiology for 3 months or more, and (2) pain in 11 of 18 tender point sites on digital palpation.

As occasion requires (PRN) use of NSAIDs and/or Cox II inhibitors was permitted provided that total dosing did not vary on average more than 50% from 1 week to the next over any given month during the past 90 days, and that no new PRN pain medication was introduced within 90 days of study enrollment. All medication and supplement use was documented during the screening process.

Exclusion criteria included narcotic analgesic use, rheumatologic disease, chronic infections, untreated endocrine disorders, unstable seizure disorders, previously diagnosed psychiatric disorders, acute peptic ulcer disease, congestive heart failure, chronic liver disorders and/or bleeding diathesis. Pregnant women and those unwilling to stop vitamin and mineral supplementation prior to and during the course of the study were excluded.

Prescription medications for conditions unrelated to FMS were included, provided a stable dosing regimen for 60 days prior to enrollment. A minimum of 90 days of stable dosing was required for all classes of antidepressants and anxiolytics.

Other modalities of treatment specifically for FMS, such as acupuncture or osteopathy, were discontinued for 2 weeks prior to enrollment. Subjects agreed to discontinue all vitamin/mineral supplementation throughout the study period.

Potential subjects exhibiting allergy to thiamine, as determined by a visible wheal following intradermal injection of 0.1 mL of diluted thiamine, were excluded as well as previous treatment with the Myers’ Cocktail.

Interventions

The intervention is based on the current Myers’ cocktail containing:

  • 5 mL of magnesium chloride hexahydrate (20%)
  • 3 mL of calcium gluconate (10%)
  • 1 mL of hydroxocobalamin (1,000 μ/mL)
  • 1 mL of pyridoxine hydrochloride (100 mg/mL)
  • 1 mL of dexpanthenol (250 mg/mL)
  • 1 mL of B-complex 100 containing:
    • 100 mg of thiamine HCl, 2 mg of riboflavin, 2 mg of pyridoxine HCl, and 2 mg of panthenol
    • 100 mg of niacinamide, 2% benxyl alcohol
    • 5 mL of vitamin C (500 mg/mL)
    • 20 mL of sterile water.

The solution is bright yellow and contains 37 mL of relatively high doses of water-soluble vitamins and minerals and sterile water. Prior to study inception, an Investigational New Drug (IND) application to the FDA was submitted and approved (IND 66,885).

Intervention solutions were prepared within 1 hour of administration, under a sterile hood, and double-checked for accuracy by the Joint Commission on Accreditation of Healthcare Organizations–accredited Griffin Hospital Inpatient Pharmacy. The placebo infusion consisted of 37 mL lactated Ringer’s solution. Preparation costs for one dose of IVMT was $18 US.

Subjects received intervention or placebo solutions intravenously in the antecubital fossa using a slow-push infusion delivered over approximately 10 minutes using a 25-gauge butterfly needle. Subjects received infusions, once weekly for 8 weeks, at the Integrative Medicine Center at Griffin Hospital, Derby, CT.

Objectives

This pilot study was designed to assess safety and feasibility, and to provide preliminary data regarding efficacy of IVMT for FMS as compared to an intravenous lactated Ringer’s placebo.

Outcomes

The primary outcome measure was change in the Tender Point Index (TPI), assessed by a single board-certified rheumatologist. Secondary corroborative measures included a Visual Analogue Scale (VAS) to assess global pain, the Fibromyalgia Impact Questionnaire (FIQ) to assess physical function, the Beck Depression Inventory (BDI), and Health Status Questionnaire 2.0 (HSQ 2.0)to assess subjects’ self-perceived mood and general well-being.

Outcomes were measured at baseline, end of treatment period (8 weeks), and after a 4-week washout period (12 weeks) (Table 1).

Evaluation Tools and Outcome Measures
Sample size

The sample size was determined to allow for 20% attrition and noncompliance and provide at least 80% power to detect a minimal difference of 2.0 points in the TPI between the experimental and placebo group with a maximum allowable type I error of 5%. A standard deviation of 2 points in the TPI was used to compute the sample size.

Randomization

Subjects went through a 2-week run-in period to assess the stability of FMS medication use. Those demonstrating the ability to successfully complete the run-in period (i.e., maintain stable dosing of FMS medications) were assigned by balance allocation to either IVMT or placebo. Randomization was performed by the data manager with gender stratification in blocks of two to assure optimal balance between groups using SAS Software (SAS Institute, Cary, NC). Subjects were enrolled by a study coordinator unblinded to group allocation.

Study design

This pilot study was a randomized, double-blind, placebo-controlled clinical trial. Once deemed eligible, subjects were randomized to receive eight weekly intravenous infusions of either IVMT (intervention) or lactated Ringer’s solution (control).

Blinding

The infusion nurse and subject were blinded to treatment assignment by means of placing an opaque sheet over the syringe and cannula between the nurse and subject. All tender point examinations were performed by a single board-certified rheumatologist who was blinded to treatment assignment. Other self-report instruments were delivered by a study coordinator and research assistant unblinded to treatment assignment.

Statistical methods

Data were analyzed using SAS software for Windows version 9.1. Validated scoring techniques were used to calculate total survey scores for the BDI, HSQ, and FIQ. Responses for individual survey questions were scored and then added to produce a total survey score for each study participant. The Fibromyalgia Intensity Score for each patient was calculated by dividing the TPI Total Survey Site Scores by 18 tender-point sites tested in the survey. Individual patient readings for the VAS were converted to scores ranging from 0 to 100, based on a linear scale of 10 segments and each segment 10 mm in length. Comparisons of all survey scores for the IVMT and Placebo groups were done at three time points: baseline, 8 weeks after the start of intervention, and 12 weeks after the start of intervention. Descriptive analyses of individual surveys showed that the data were not normally distributed. Therefore, nonparametric statistics were used to analyze the outcomes of interest. Within-group changes in the outcome measures were calculated by subtracting each score at 8 weeks and at 12 weeks from the baseline score. Differences in the change in outcome measures between the two groups were assessed using the Wilcoxon rank-sum test. In all analyses, a two-tailed α of less than 0.05 was considered statistically significant. The continuous data are presented as means ± standard deviation in the text and tables.

Results
Participant flow (Fig. 1)

Flow of participants through the trial. IVMT, intravenous micronutrient therapy.

A total of 263 potential subjects were screened by phone; 55 were eligible for clinical screening. Approximately 40% of those deemed ineligible after phone screen were taking narcotic analgesics, while approximately 20% cited distance from study center or disinterest in participating. Other subjects were excluded due to a pre-existing health condition, a lack of stability on medications, unwillingness to discontinue vitamins, or lack of FMS diagnosed by a board certified rheumatologist. Clinical screening consisting of TPI examination was performed by a board-certified rheumatologist on 44 candidates; 35 were randomized to IVMT or placebo. Of those eligible for clinical screen, 11 were not interested in continuing with the study, or could not be reached to schedule an appointment. Of the 9 that were excluded after clinical screen, 4 exhibited sensitivity to thiamine, and 5 were found to be unstable on their medication (Fig. 1). One 1 subject in the IVMT group and 2 subjects in the placebo group dropped out prior to the 12-week assessment; all were unwilling to travel to the study site. Ultimately, 31 subjects completed the 8-week intervention and follow-up assessment.

Recruitment

Subjects were recruited by internet announcements, press releases, newspaper advertisements, presentations to FMS support groups, and mailings to rheumatologists and naturopathic physicians between September 2003 and October 2005 in south central Connecticut. Screening and data collection took place at Yale-Griffin Prevention Research Center in Derby, CT.

Baseline data

The two groups were comparable in terms of demographic and baseline characteristics (Table 2). All but 1 subject were female; 1 male was in the IVMT group. Mean ages were 51.7 ± 12.1 years and 50.7 ± 8.2 years, for the IVMT and placebo groups, respectively.

Demographic Characteristics and Outcomes of Interest at Baseline
Numbers analyzed

Thirty-four (34) subjects enrolled and completed at least one of the two follow-up assessments: 16 in the IVMT group and 18 in the placebo group. Analyses were based on the intention-to-treat principle, by substituting missing values with the reported values from the 8-week evaluation for the subjects who dropped out prior to completing the study.

Outcomes

Between-group comparisons of individual variables did not reach statistical significance (all p-values > 0.05) (Tables 3 and ​and4);4); no significant differences were seen in participants assigned to IVMT or lactated Ringer’s solution. Following the treatment period (8 weeks), mean Total Survey Sites Score (intervention −18.7 ± 26.5; placebo −16.6 ± 31.2; p = 0.60) and mean Fibromyalgia Intensity Score (intervention −1.1 ± 1.4; placebo −0.9 ± 1.7; p = 0.50) decreased in both groups indicating improvement in tender points.

Change in Outcome Measures at 8 Weeks Following Treatment (Intent-to-Treat)

Change in Outcome Measures at 12 Weeks Following Treatment (Intent-to-Treat)

Tables 3 and ​and44 summarize the results for 8-week and 12-week evaluations, respectively.

Ancillary analyses

The within-group decreases in TPI scores was significant in the IVMT arm (−18.7 ± 26.5, p = 0.02 in Total Survey Site Scores and −1.1 ± 1.4, p = 0.02 in the Fibromyalgia Intensity Score) as well as in the placebo arm (−16.6 ± 31.2, p = 0.04 in Total Survey Site Scores and −0.9 ± 1.7, p = 0.05 in the Fibromyalgia Intensity Score) (Table 3). At the 12-week assessment, TPI scores remained improved from baseline in both IVMT (−17.1 ± 24.6, p = 0.01 in Total Survey Site Scores and −1.0 ± 1.4, p = 0.01 in the Fibromyalgia Intensity Score) and placebo groups (−20.7 ± 25.4, p = 0.01 in Total Survey Site Scores and −1.1 ± 1.4, p = 0.02 in the Fibromyalgia Intensity Score) (Table 4

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6 Spine Technology Highlights

Technology Highights from the 32nd Annual Meeting of the North American Spine Society

Written by Susan Spinasanta
More than 200 exhibitors occupied the immense exhibition hall at the 32nd Annual Meeting of the North American Spine Society in Orlando, FL. It was a medical, scientific and technological Who’s Who of the spine world. SpineUniverse met with many industry leaders and randomly chose 6 to highlight in this snapshot.

Ocular surgeon sees spine market with an eye for healing
SpineUniverse met with Thomas Dugan, Chief Executive Officer of Amniox Medical, a TissueTech Company that was founded by Scheffer Tseng, a MD, PhD, ocular surgeon in Miami. Tseng was the first to commercialize amniotic membrane for clinical use (Bio-Tissue). The company draws on a 25+ year history of extensive and continuous research, much of it NIH funded, that provides the scientific underpinning of their technology.

Today, the amniotic layer and umbilical cord’s unique regenerative and healing properties are utilized to improve microdiscectomy outcomes (via the newly launched RESPINA brand). In a recently published article in Clinical Spine Surgery, Anderson et al studied 80 patients who were randomized in a 1:1 ratio to receive cryopreserved amniotic tissue (cAM) or no tissue at a single site following lumbar microdiscectomy.1 “The cAM group had statistically significant improvements and zero re-herniations at the 2-year follow-up, and Amniox has committed to following these patients to 5-years,” Dugan indicated.

Dugan also commented on new research “showing an anti-inflammatory impact, and that HC-HA/PTX3 [novel regenerative matrix from the placental tissue] also shows promise in significantly reducing back pain.” An injectable form of the product may have broad pain indications, and patients are reporting greater pain relief than from corticosteroids.

Reference
1. Anderson DG, Popov V, Raines AL, O’Connel J. Cryopreserved amniotic membrane improves clinical outcomes following microdiscectomy. Clin Spine Surg. 2017 Nov;30(9):413-418.

Molding an optimal platform for bone growth
“As the synthetics’ field continues to evolve, technology has also improved so that you can try to mimic, as much as possible, the properties of bone, and recreate the natural scaffold for cells, other growth factors and other key constituents of the human body to facilitate the remodeling process—this will actually help to optimize bone formation,” stated Samson Tom, PhD, Vice President, R&D of Bioventus. His comment led to a discussion about biomaterials, and an interesting demonstration by Steven Moore, Director of US Marketing.

The demonstration involved a new product called OSTEOMATRIX+, which is a novel strip comprised of three primary components (beta-tricalcium phosphate, hydroxyapatite, and collagen). The reabsorption rate of each mineral differs, and that helps to initiate and facilitate the repair process. “If you have something that remodels too quickly, then obviously you’re not offering a three-dimensional architecture that’s required for proper bone healing to occur. So we’ve optimized the ratio of the two minerals in this particular strip,” stated Moore. “In addition, our processing methodology for the collagen component results in handling properties that are very unique compared to many other grafts that are out there today,” he said.

Rehydrating the strip displayed its fluid uptake capability mimicking potential bone marrow aspirate uptake in a surgical setting. Its ability to be easily molded helped demonstrate how it may enable bony contact and eliminate voids. “It’s a strip that acts like a putty,” stated Moore. Furthermore, “It retains its integrity … it does not fall apart,” Tom commented.

OSTEOMATRIX+ from Bioventus will be available in the spring of 2018.

Eliminating doubt about robotic-guided spine surgery
Mazor Robotics, an industry leader for 16 years, demonstrated its Mazor Core technology and presented results from its MIS ReFRESH prospective comparative study during NASS 2017.

Dr. Doron Dinstein, the company’s Chief Medical Officer, explained Mazor Core’s key technologies—its surgical planning suite’s 3D analytics and virtual tools, anatomy recognition software and cross-modality registration that collectively provides surgical predictability and precision. “Mazor Core is clearly differentiating what we do from navigation-based systems,” Dinstein stated.

The MIS ReFRESH multi-center study enrolled 379 patients; 287 were in the robotic-guided arm, and 92 were in the fluoro-guided arm. Christopher Good, MD presented the results, which were significant. In the robotic-guided arm, surgical complications were reduced 5.3-fold using the Mazor Core Technology. Furthermore, the revision rate fell 7.1-fold.1

Reference
1. Schroerlucke SR, Wang MY, Cannestra A, Good CR, et al. Complications and revision rates in robotic-guided vs fluro-guided minimally invasive lumbar fusion surgery. North American Spine Society, 32nd Annual Meeting, October 25-28, 2017, Orlando, FL.

Versatile surgical patient positioning platform
Mizuho OSI® introduced its Levó Head Positioning System during the North American Spine Society’s Annual Meeting. Tina Dendrinos, Manager of Product Marketing demonstrated the technology’s additional capabilities for spine surgery. Mizuho OSI is a US-based company and subsidiary of Mizuho Corporation in Tokyo.

Levó’s electromechanical technology powers its ability to set and maintain precise head positioning throughout surgical procedures involving all spinal levels—cervical to sacral. Intraoperative adjustments are easily achieved using the Control Handles and does not require the surgeon or the team to break scrub or compromise the sterile field. Modular components, such as the Dual Motion Base, which allows both longitudinal and lateral movement, and the Prone Platform, which supports a face cushion, provide for different types of patient positioning as required.

“The development team focused on designing a technology that directly addressed the need for improved head positioning capabilities. We are excited to bring our users a new level of control and precision powered by the device’s electromechanical design,” Dendrinos stated.

Where every single millimeter matters
The ORBEYE video microscope is a game-changing surgical technology developed through a partnership between Sony and Olympus. SpineUniverse met with James Lockwood, Director of Marketing Video Microscopy at Olympus America Inc., who demonstrated this “first of its kind” end-to-end 4K, 3D surgical visualization system offering a broad color gamut for tissue delineation.

“The premise is that with traditional surgical ocular microscopes, both the patient and surgeon positioning has to adjust to accommodate the microscope. But with ORBEYE, you have complete freedom of movement and angulation—visualization adjusts to the surgeon’s and patient’s position,” stated Lockwood. The surgeon operates in a natural stance; standing heads-up to view a 55-inch, 4K, 3D monitor—which is ergonomically advantageous considering the duration of some surgeries. Furthermore, Lockwood stated, “The 4K, 3D camera has a very small profile that opens up the surgical field for instrumentation, and its optics offer a high degree of magnification capabilities—up to 26 times optical sight—to visualize neural structures or bony elements.”

3D-printed cervical implant “engineered for bone”
Stryker’s Spine Division introduced its Tritanium® C Anterior Cervical Cage at the 32nd Annual Meeting of the North American Spine Society. We learned that while additive manufacturing may seem to be a recent development, Stryker set out as early as 2001 to industrialize 3D printing for healthcare. According to Stryker’s backgrounder, “The unique porous structure is created to provide a favorable environment for cell attachment and proliferation … and the Tritanium material may be able to wick or retain fluid.”

“This is another great product by Stryker that brings revolutionary technology to the operating room. With many product sizes and lordosis options, I felt like I could truly match the anatomy and needs of the patient with the implant. I look forward to using the Tritanium C Anterior Cervical cage product in more spinal surgeries and being part of the success that this new technology will bring to my patients,” stated Lance C. Smith, MD. Dr Smith is an an Orthopaedic Surgeon at McBride Orthopedic Hospital in Oklahoma City, OK.

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Opioid Dependence is beyond an emerging problem in this country. It is no secret that it is now a national epidemic and public health crisis. Fueled by aggressive marketing and manufacturing strategies by the pharmaceutical industry; government incentives aimed toward reducing pain and labeling pain as the “5th Vital sign,” and then tying patient satisfaction and reimbursement to subjective pain scores; the compassionate tenants of our society; some unscrupulous physician practices; and misinformation to providers and patients alike, regarding the long term effects of opioids. We now find ourselves faced with the daunting task of re-orienting our approach to pain management and the expectations around pain control.

Suboxone therapy or buprenorphine along with psychological, and traditional medical services appears to be the treatment of choice at this time. Increasing access to this medical modality and helping providers and patients identify opioid dependency is the first step toward restoring a state of internal harmony for patients that sit at the crux of this historical nightmare.  

Buprenorphine is known as a partial agonist and partial antagonist. Meaning it partially acts on the opioid receptor, and partially blocks the opioid receptor. This is in comparison to drugs such as Heroin, Morphine, Fentanyl, Oxycodone (found in Percocet), Hydrocodone (found in Vicodin), as well as Codeine that act only as an agonist (receptor activator).  

The analgesic (pain relieving effects) of an opioid molecule primarily take place with Mu receptor activation in the Ventral Tegmental Area, Nucleus Accumbens, and Locus Coeruleus regions of the brain.  

Naltrexone and naloxone are examples of additional drugs that bind to the Mu receptor. However, unlike Buprenorphine, these molecules have pure antagonist effects. That means they block the Mu receptor and prevent the analgesic effects of opioids, along with some of the other potential effects of opioids such as sedation and respiratory depression (slowed breathing) or failure (the inability to breadth). That is why these drugs are employed respectively, to help people avoid opioids altogether or treat opioid overdoses.

Buprenorphine, Naloxone or Naltrexone, and molecules such as Heroin and Vicodin, have different levels of affinity to the mu receptors in the brain. They also have different lengths of time for which they bind to the opioid receptor before releasing their grip on these Mu receptors.  

Understanding this complex pharmacology, neurological, and behavioral reward system; and how these molecules impact an individual’s cognitive-emotional state, behavior, and overall functioning; is critical to restoring a state of physiological, mental, and spiritual well-being.

Discuss with your physician if Suboxone Therapy is a treatment option for you.

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