Actipatch – an electroceutical for pain relief

https://www.facebook.com/novaddiction/ Facebook – Novaddiction page

Addiction management – suboxone/probuphine/Naltrexone support therapies – Alexandria, Va

I attached the link to an article of recent technologies for pain management. One of the more interesting ones was the Actipatch. I plagiarized the article below. What is interesting about this device is it is OTC and is an electroceutical agent that produces signals at 1 KHz into painful tissues to dampen pain perception.

Distributors

Patients are unable to sense the stimulus, unlike with standard TENS units!

 

Five New Pain management Treatments available: Link to article

 

3. ActiPatch®

Company:  BioElectronics Corporation

Release Date: Will be featured at Pharmacy Week in Trinidad and Tobago, October 16th to the 23rd, 2016.

Applications: Chronic pain from osteoarthritis, rheumatoid arthritis, shingles, neuropathy, sports injuries, and fibromyalgia, and post-surgical pain

About this technology: Actipatch is a non-invasive, electroceutical device which uses electromagnetic fields to modulate efferent nerve activity, dampening the brain’s perception of pain. The device pulses signals at 1 kHz into the painful tissue, preventing the brain from adapting to the stimulus.

Efficacy: Completed clinical trials indicate device efficacy in reducing pain (including musculoskeletal, postoperative, and menstrual pain), and restoring normal function, such as allowing people to get a full nights’ sleep, in many patients.

A trial published in Pain Management showed that out of 5002 study participants who provided feedback after testing the ActiPatch, efficacy rate varied from 59% to 71% for different pain conditions, with an average of a 50% reduction in medication use (including prescriptions).3 Sixty seven percent of study participants reported that they were able to eliminate or reduce opioid use, 70% reported improved sleep, and 74% reported that they could be more physically active.

According to Ken McLeod, PhD, Director of Clinical Science and Engineering at Binghamton University, patients using ActiPatch do not feel any tingling, heat, or vibration, unlike with TENS.

It is currently the only neuromodulation electroceutical device available over-the-counter for managing chronic pain. It is safe to use with metal implants, pacemakers, and defibrillators, as well as in diabetics, arthritics, and the elderly. It is not for use in pregnant women. It allows for 720 hours of use and has an on/off switch.

 

Video

pulsed-electromagnetic-fields-in-knee-osteoarthritis << study described below:

Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial

Gian Luca Bagnato1 , Giovanni Miceli1 , Natale Marino1 , Davide Sciortino1 and Gian Filippo Bagnato1

Abstract

Objectives.

This trial aimed to test the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients. Methods. In this randomized [with equal randomization (1:1)], double-blind, placebo-controlled clinical trial, patients with radiographic evidence of knee OA and persistent pain higher than 40 mm on the visual analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in 60 knee OA patients. The primary outcome measure was the reduction in pain intensity, assessed through VAS and WOMAC scores. Secondary outcomes included quality of life assessment through the 36-item Medical Outcomes Study Short-Form version 2 (SF-36 v2), pressure pain threshold (PPT) and changes in intake of NSAIDs/analgesics.

Results.

Sixty-six patients were included, and 60 completed the study. After 1 month, PEMF induced a significant reduction in VAS pain and WOMAC scores compared with placebo. Additionally, pain tolerance, as expressed by PPT changes, and physical health improved in PEMF-treated patients. A mean treatment effect of 0.73 (95% CI 1.24 to 0.19) was seen in VAS score, while the effect size was 0.34 (95% CI 0.85 to 0.17) for WOMAC score. Twenty-six per cent of patients in the PEMF group stopped NSAID/analgesic therapy. No adverse events were detected.

Conclusion.

These results suggest that PEMF therapy is effective for pain management in knee OA patients and also affects pain threshold and physical functioning. Future larger studies, including head-to-head studies comparing PEMF therapy with standard pharmacological approaches in OA, are warranted. 

Chronic Musculoskeletal Pain

Key user findings:

  • Average 50% reduction in medication use, including prescription drugs
  • 67% including opioid users reported moderate to complete elimination of pain medication
  • 70% reported better sleep
  • 74% reported they are more physically active
  • 84% reported a moderate to a great deal better quality of life.
  • 85% stated they would continue long term use of the retail device

a-uk-registry-study-of-the-effectiveness-of-a-new-otc-chronic-pain-therapy  < Another study link of an article demonstrating the effectiveness of this therapy.

Background: The ActiPatch® (BioElectronics Corporation, MD, USA) pulsed shortwave therapy device has been shown to be clinically effective in three double-blind randomized controlled pain studies. However, the effectiveness of this device in a broader population of chronic musculoskeletal pain sufferers, affected by a variety of etiologies in different regions of the body, has not been studied. Aim: The objective of this registry study was to assess the effectiveness and satisfaction of the ActiPatch device in the general population of chronic pain sufferers. Methods: A total of 44,000 subjects completed the trial, with 5000 assessments of the device collected. Conclusion: The ActiPatch device appears to provide a clinically meaningful reduction of chronic musculoskeletal pain affecting different locations of the body caused by a variety of etiologies.

● Musculoskeletal pain is widespread in the community.

● Wearable pulsed shortwave therapy is a new over-the-counter pain therapy in the UK and has not been shown to have any significant side effects, even in the elderly or subjects with diabetes.

● This registry study included 44,000 subjects who tried the device, with 5000 submitting an assessment.

● Subjects reported on average severe baseline pain which was present despite using on average two pain modalities including analgesics, heat wraps, transcutaneous electrical nerve stimulation and other pain therapies

. ● Current pain modalities appear to be inadequate and ineffective for many individuals.

● In the study over 65% reported a clinically meaningful reduction in pain from a wide variety of etiologies and locations of pain

. ● The average pain reduction reported in these individuals was 57%.

● The 3-month follow-up showed sustained pain relief, decreased oral analgesic medication use and quality of life improvement.

● Pulsed shortwave therapy offers a new alternative safe chronic pain therapy.

pulsed-radiofrequency-electromagnetic-field-therapy-a-potential-novel-treatment-for-plantar-fascitis

Abstract:

Plantar fasciitis is a common cause of heel pain, and although treatments are usually conservative, they can take up to 2 years to achieve resolution. A double-blind, multicenter, randomized, placebo-controlled study was used to evaluate a small, wearable, extended-use pulsed radiofrequency electromagnetic field (PRFE) device as a treatment of plantar fasciitis. A total of 70 subjects diagnosed with plantar fasciitis were enrolled in the present study. The subjects were randomly assigned a placebo or active PRFE device. The subjects were instructed to wear the PRFE device overnight, record their morning and evening pain using a 0- to 10-point visual analog scale (VAS), and log any medication use. The primary outcome measure for the present study was morning pain, a hallmark of plantar fasciitis. The study group using the active PRFE device showed progressive decline in morning pain. The day 7 AM-VAS score was 40% lower than the day 1 AM-VAS score. The control group, in comparison, showed a 7% decline. A significantly different decline was demonstrated between the 2 groups (p ¼ .03). The PM-VAS scores declined by 30% in the study group and 19% in the control group, although the difference was not significant. Medication use in the study group also showed a trend downward, but the use in the control group remained consistent with the day 1 levels. PRFE therapy worn on a nightly basis appears to be helpful.

actipatch-survey-results  < Actipatch survey

Clinical Evidence

control-of-postoperative-pain-with-a-wearable-continuously-operating-pulse-frequency-energy-device

white-paper-postoperative-dental-implant-operti-tealdo-march-2014

Discussion

Although this was an observational study and there were no controls, the results are very encouraging. Whilst patients undergoing a single implant can recover quickly, most patients who have multiple implants normally need to take strong analgesics and many are unable to resume normal daily activities for a number of days post-operatively. Follow up at 24-48 hours post-op showed that all patients who used RecoveryRx Therapy could resume normal masticatory function. This would not normally have been possible at this stage of recovery. Further studies are needed to objectively study the observed beneficial effects in dental implant patients; even greater benefit may have been observed if the device had been used continuously and not for just twelve hours. It is difficult to avoid the conclusion that, in an area that is normally very painful and swells easily after surgery, the RecoveryRx Therapy provided clinically meaningful benefit.

 

use-of-radio-frequency-pulsed-energy-in-the-control-of-postoperative-reaction-in-blepharoplasty

Abstract. This is a preliminary report of the use of a device to apply small pulses of radio-frequency energy to surgical wounds in order to improve wound healing. The device was applied to one eye in 21 patients who underwent bilateral blepharoplasty. There were no devicerelated complications. In l l patients, edema and ecchymosis were noticeably less on the treated side within 24 hours of surgery. In 6 patients, ecchymosis and swelling were so slight that no difference between treated and untreated sides was visible. Two patients were noticeably worse on the treated side. Further studies will be conducted.

 

 

 

Metabolic features of chronic fatigue syndrome – PNAS

http://www.novaddiction.com/ – Addiction treatment center – Alexandria, VA -Suboxone/Probuphine/Naltrexone therapies available

Metabolomic deficiencies in Chronic Fatigue Syndrome

Metabolic characteristics in CFS article link

metabolic-features-of-chronic-fatigue-syndrome-pnas << PNAS article link

In a study designed to test the utility of targeted metabolomics in the diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), researchers identified a unique chemical signature that differentiates affected patients from healthy individuals.

The study, led by Dr Robert K. Naviaux, MD, PhD of The Mitochondrial and Metabolic Disease Center at the University of California’s San Diego School of Medicine, was published August 29 in the Proceedings of the National Academy of Sciences in the United States .1

Ronald W. Davis, PhD, director of Stanford Chronic Fatigue Syndrome Research Center of Stanford University School of Medicine commented on the findings of Dr Naviaux’s group on the the Open Medicine Foundation website, where he serves as director of the Scientific Advisory Board.

Abstract for article:

More than 2 million people in the United States have myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). We performed targeted, broad-spectrum metabolomics to gain insights into the biology of CFS. We studied a total of 84 subjects using these methods. Forty-five subjects (n = 22 men and 23 women) met diagnostic criteria for ME/CFS by Institute of Medicine, Canadian, and Fukuda criteria. Thirty-nine subjects (n = 18 men and 21 women) were age- and sexmatched normal controls. Males with CFS were 53 (±2.8) y old (mean ± SEM; range, 21–67 y). Females were 52 (±2.5) y old (range, 20–67 y). The Karnofsky performance scores were 62 (±3.2) for males and 54 (±3.3) for females. We targeted 612 metabolites in plasma from 63 biochemical pathways by hydrophilic interaction liquid chromatography, electrospray ionization, and tandem mass spectrometry in a single-injection method. Patients with CFS showed abnormalities in 20 metabolic pathways. Eighty percent of the diagnostic metabolites were decreased, consistent with a hypometabolic syndrome. Pathway abnormalities included sphingolipid, phospholipid, purine, cholesterol, microbiome, pyrroline-5-carboxylate, riboflavin, branch chain amino acid, peroxisomal, and mitochondrial metabolism. Area under the receiver operator characteristic curve analysis showed diagnostic accuracies of 94% [95% confidence interval (CI), 84–100%] in males using eight metabolites and 96% (95% CI, 86–100%) in females using 13 metabolites. Our data show that despite the heterogeneity of factors leading to CFS, the cellular metabolic response in patients was homogeneous, statistically robust, and chemically similar to the evolutionarily conserved persistence response to environmental stress known as dauer.

Significance:

Chronic fatigue syndrome is a multisystem disease that causes longterm pain and disability. It is difficult to diagnose because of its protean symptoms and the lack of a diagnostic laboratory test. We report that targeted, broad-spectrum metabolomics of plasma not only revealed a characteristic chemical signature but also revealed an unexpected underlying biology. Metabolomics showed that chronic fatigue syndrome is a highly concerted hypometabolic response to environmental stress that traces to mitochondria and was similar to the classically studied developmental state of dauer. This discovery opens a fresh path for the rational development of new therapeutics and identifies metabolomics as a powerful tool to identify the chemical differences that contribute to health and disease.

 

 

 

  1. Naviaux RK, Naviaux JC, Li K, et al. Metabolic features of chronic fatigue syndrome. Proc Natl Acad Sci U S A. 2016;113(37):E5472-5480. doi:10.1073/pnas.1607571113.
  2. Beger RD, Dunn W, Schmidt MA, et al. Metabolomics enables precision medicine: “A White Paper, Community Perspective.” Metabolomics Off J Metabolomic Soc. 2016;12(10):149. doi:10.1007/s11306-016-1094-1096.
  3. White PD, Goldsmith KA, Johnson AL, et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet Lond Engl. 2011;377(9768):823-836. doi:10.1016/S0140-6736(11)60096-2.
  4. Goldin R. PACE: The research that sparked a patient rebellion and challenged medicine. STATS.org. http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/. Published March 21, 2016. Accessed September 26, 2016.

Assessing the Validity of Online Drug Forums as a Source for Estimating Demographic and Temporal Trends in Drug Use

https://www.facebook.com/novaddiction/

http://www.novaddiction.com/

Journal of Addiction Article on assessing the validity of online drug forums  < Article link.

Online drug forums do help determine temporal trends in drug abuse.

Assessing the Validity of Online Drug Forums as a Source for Estimating Demographic and Temporal Trends in Drug Use:

Abstract:

 

Objectives: Addiction researchers have begun monitoring online forums to uncover self-reported details about use and effects of emerging drugs. The use of such online data sources has not been validated against data from large epidemiological surveys. This study aimed to characterize and compare the demographic and temporal trends associated with drug use as reported in online forums and in a large epidemiological survey.

Methods: Data were collected from the Web site, drugs-forum.com, from January 2007 through August 2012 (143,416 messages posted by 8087 members) and from the US National Survey on Drug Use and Health (NSDUH) from 2007 to 2012. Measures of forum participation levels were compared with and validated against 2 measures from the NSDUH survey data: percentage of people using the drug in past 30 days and percentage using the drug more than 100 times in the past year. Results: For established drugs (eg, cannabis), significant correlations were found across demographic groups between drugsforum.com and the NSDUH survey data, whereas weaker, nonsignificant correlations were found with temporal trends. Emerging drugs (eg, Salvia divinorum) were strongly associated with male users in the forum, in agreement with survey-derived data, and had temporal patterns that increased in synchrony with poison control reports.

Conclusions: These results offer the first assessment of online drug forums as a valid source for estimating demographic and temporal trends in drug use. The analyses suggest that online forums are a reliable source for estimation of demographic associations and early identification of emerging drugs, but a less reliable source for measurement of long-term temporal trends.

Buproprion and abuse potential

https://www.facebook.com/novaddiction/

http://www.novaddiction.com/

bupropion-abuse-reported-to-us-poison-centers <Article link

bupropion-box

Abstract:

Objectives: Bupropion use to obtain nonmedical psychoactive effects has been reported. The objective was to determine the prevalence, characteristics, clinical effects, and outcomes of bupropion ‘‘abuse.’’ Methods: A 14-year retrospective review was conducted of single substance bupropion cases with ‘‘intentional abuse’’ as the coded reason for exposure in individuals 13 and older reported to the National Poison Data System. Data were evaluated for prevalence, demographics, clinical effect, route, final management site, and coded outcome. Results: There were 975 bupropion abuse cases, which accounted for 3.3% of single substance bupropion cases reported to US poison centers. The prevalence of abuse increased by 75%, from 2000 to 2012, declining slightly in 2013. The majority of cases were 13 to 29 years old (67.4%). The most frequent clinical effects were tachycardia (57.0%), seizures (33.5%), agitation/irritable (20.2%), hallucinations/delusions (14.0%), and tremor (13.1%). Most exposures were ingestions (745) followed by insufflation (166), parenteral (17), and other/unknown (17); 30 cases involved 2 routes. Seizure frequency was not significantly different between routes (P ¼ 0.783) or exposure chronicity (P ¼ 0.264). Final management sites were predominantly emergency department (36.9%) and admission to critical care unit (27.3%) or noncritical care unit (20.1%). Outcomes were major (11.4%), moderate (48.2%), minor (24.5%), and no effect (15.5%). There were 4 deaths. Conclusions: Most bupropion abuse occurs in adolescents and young adults. Tachycardia and seizures are common indicating the potential for serious effects. Seizures occur regardless of route. Providers should be aware of risk of bupropion abuse.

 

 

https://www.erowid.org/experiences/exp.php?ID=67096 < Erowid experience

 

Kratom and scheduling by DEA

 

http://www.novaddiction.com/

https://www.facebook.com/novaddiction/

 

What the Scheduling of Kratom by the DEA Means for Research

At the end of August 2016, the Drug Enforcement Administration (DEA) announced its intent to place the active components of kratom into Schedule I of the Controlled Substances Act, due to 15 known deaths related to kratom between 2014 and 2016, as well as its “high potential for abuse,” and lack of an “accepted medical use… in the United States.”

However, due to a widespread outcry, including a letter to the DEA from 51 members of Congress, questioning the decision and a lack of opportunity for public comment, the DEA is placing a hold on this decision.

The status moving forward is uncertain, as the DEA has not issued a public statement, but it is hoped the organization will seek out input from the public before reaching a decision. The original intent to place kratom in the Schedule I category was invoked using a rarely used emergency power that states the DEA need only issue a 30 day notice.

“The DEA’s decision to place kratom as a Schedule I substance will put a halt on federally funded research and innovation surrounding the treatment of individuals suffering from opioid and other addictions,” the members of Congress wrote in their letter to Charles P. Rosenberg, the Acting Administrator of the DEA, and to the director of the White House Office of Management and Budget.

“This significant regulatory action was done without any opportunity for public comment from researchers, consumers and other stakeholders… This hasty decision could have serious effects on consumer access and choice of an internationally recognized herbal supplement.”

Some kava bar owners as well as the American Kratom Association (AKA), an organization of kratom consumers which receives some of its funding from kratom vendors, are taking action against the proposed scheduling of kratom, questioning the DEA’s hasty decision and the quality of the research on which their decision is based.

David Fox and Lynn Mehler, partners in the Los Angeles-based law firm of Hogan Lovells, wrote a letter to the DEA stating, “AKA takes very seriously DEA’s concern that approximately 30 reports of fatalities have been linked to consumers who had ingested or possessed a kratom product. However, a close examination of these reports shows that there are no instances in which kratom itself was determined to be responsible for the cause of death[…] There is good reason to question whether these reports indeed represent a valid or meaningful signal with respect to kratom. Close review of the totality of evidence points clearly in the other direction, namely, that kratom is well tolerated and relatively mild in its effects.”

Impeding Research Opportunities?

Kratom comes from a tree in southeast Asia, the Mitrargyna speciosa korth. Its active ingredients, the opioids mitragynine and 7-hydroxymitragynine, make it a popular alternative to opioids for treating pain and for easing opioid withdrawal.

Given the opioid epidemic in the United States, researchers are hoping to find treatments for pain that are nonaddictive.

Compounds derived from the active ingredients in kratom look promising: recent research published in the Journal of Medicinal Chemistry, conducted by Susruta Majumdar, PhD, assistant attending chemist at the Memorial Sloan Kettering Cancer Center and colleagues, found that mitragynine pseudoindoxyl, a semi-synthetic opioid derived from mitragynine, one of the active ingredients in Kratom, appeared to more effectively relieve pain in mice, compared with morphine, without many of the dangers and unpleasant adverse effects caused by opioids.1

“In vitro, mitragynine pseudoindoxyl and its analogs were potent agonists in [35S] GTPγS assays at the µ-opioid receptor but failed to recruit β-arrestin-2, which is associated with opioid side effects,” the authors wrote.

“Additionally, mitragynine pseudoindoxyl developed analgesic tolerance more slowly than morphine, showed limited physical dependence, respiratory depression, constipation, and displayed no reward or aversion in Conditioned Place Preference assays, suggesting that analogs might represent a promising new generation of novel pain relievers,” they added.

Placing kratom in Schedule I of the Controlled Substances Act would impede its acquisition for research purposes forcing online kratom vendors to shut down. Researchers would have no efficient way to acquire mitragynine to produce mitragynine pseudoindoxyl, which can take as long as 5 years to create in the lab in the absence of the plant.

This seems to create a conundrum: one of the reasons the DEA cites for banning kratom is a lack of evidence for its medical use. However, if kratom is banned and becomes significantly more difficult to acquire for research, its interest for clinic use may not be demonstrated.

A similar situation exists with marijuana,  also a Schedule I drug with medical potential, difficult to acquire for research purposes.

As recently as August 11, the DEA rejected 2 petitions to downgrade marijuana scheduling, which would have allowed researchers to acquire it more easily. Unfortunately, much of the issue may lie with the Controlled Substances Act itself, which has no category for substances considered too dangerous to leave unregulated, but that may have medical potential if researched.

A categorization of kratom in Schedule I by the DEA would last for 2 years, with an option to extend it to 3, while the DEA and US Food and Drug Administration examine whether kratom has an accepted medical use and decide whether to make the Schedule I categorization permanent.

With kratom in Schedule I, researchers would have to apply for a Schedule I research license and hope that the DEA would be able to supply enough quality kratom to all of those hoping to study it, although it is unclear how they would do so.

Buprenorphine (Suboxone) versus Methadone in pregnancy: The latest

https://www.facebook.com/novaddiction/

NOVA Addiction Specialists – facebook – Alexandria, Virginia

NOVA Addiction Specialists website – Alexandria, Virginia : Medical treatment for addiction, including Suboxone and Naltrexone services

Suboxone doctor locator – Alexandria, Virginia

Naltrexone – Vivitrol providers locator

Probuphine Healthcare Provider Locator

suboxone-films

A retrospective review of Buprenorphine versus methadone treatment in pregnancy in the latest Journal of Addiction:

methadone-and-buprenorphine-for-opioid-dependence-during-pregnancy  < Article Link

Abstract below:

Objectives: To compare maternal characteristics, prenatal care, and newborn outcomes in a cohort of opioid-dependent pregnant women treated with methadone versus buprenorphine.

Methods: In a retrospective cohort study, 609 pregnant, opioiddependent women were treated with methadone (n = 248) or buprenorphine (n = 361) between 2000 and 2012 at a single institution.

Results: Mothers treated with buprenorphine were more likely to start medication before or earlier in pregnancy, had longer gestation, and gave birth to larger infants. Newborns of buprenorphine- versus methadone-maintained mothers required treatment for neonatal abstinence significantly less often and for a shorter duration.

Conclusions: These data suggest pregnancy outcomes with buprenorphine to treat opioid dependence during pregnancy in clinical practice are as good and often better than outcomes with methadone. These results are consistent with efficacy data from randomized clinical trials and further support the use of buprenorphine for the treatment of opioid dependence during pregnancy.

Suboxone doctors 22314 – Virginia

Ketamine Treatment Center | 703-844-0184 | Ketamine Doctor | IV Vitamin Therapy | Vitamin Drip | Vitamin Doctor | IV NAD Therapy | Intranasal Ketamine | Ketamine for Depression Pain PTSD | IV Ketamine | Addiction Treatment Center |Suboxone | Sublocade |Vivitrol | Alcohol Treatment Center | Fairfax, Va | Addiction doctors| CBD Doctor | CBD Treatment Center | Neograft | Hair Transplantation | Hair Restoration Center | Optifast | Weight Loss Center | Medical Weight Loss | Alexandria | Springfield, Va | 22306 | 22314 | 22030 | 22304 | 22036 | 22037 | 22038 | 20598 | Low Dose Naltrexone | LDN