Difference between revisions of "Quell relief"

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However, diseases or illnesses are also identified as possible to be treated by TENS: Acute postoperative pain, primary dysmenorrhea, labor pain (which still remains controversial<ref>Sluka KA, Walsh D., Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness, in: Journal of Pain, 2003, p. 109-121</ref> ), post-stroke shoulder pain.
 
However, diseases or illnesses are also identified as possible to be treated by TENS: Acute postoperative pain, primary dysmenorrhea, labor pain (which still remains controversial<ref>Sluka KA, Walsh D., Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness, in: Journal of Pain, 2003, p. 109-121</ref> ), post-stroke shoulder pain.
 +
 
Although Quell was not created primarily to enhance cognitive or physical condition in humans, it may have secondary impact on physical and mental health (e.g. emotional stability, better memory) due to stress release, better sleep periods, and ability to be more concentrated if pain disappears. As a result should be quality of life enhanced generally.
 
Although Quell was not created primarily to enhance cognitive or physical condition in humans, it may have secondary impact on physical and mental health (e.g. emotional stability, better memory) due to stress release, better sleep periods, and ability to be more concentrated if pain disappears. As a result should be quality of life enhanced generally.
  

Revision as of 06:00, 8 December 2015

Quell is wearable device developed in purpose to provide palliative treatment for people suffering from chronical pain. Quell is commercially available, thus customers don't need any prescription from a doctor. In present, it is the only palliative wearable, which si approved by FDA to be used during sleep. Quell wearable is presented by two technological improvements, which is OptiTherapy™ electrode and transcutaneous electrical nerve stimulation (TENS), method allowing sending electrical pulses into afferent nerves through the skin.

QUELL RELIEF
Quell.jpg
Category Therapeutic wearables
Developer NeuroMetrix
Announced Oct 2015
Released Consumers: 2015
Price 249 USD
Weight 62 g
Dimensions 98 x 74 x 11 mm
Controls smartphone
Standalone[1]
https://www.quellrelief.com/product


Main characteristics

Components

The basic product a customer can buy, called Quell wearable pain relief - starter kit[2], includes one piece of Quell device, adjustable sports band, charger cable, and charger adapter, and two 2 electrodes (company claims one month supply).

User have to buy accessories in addition like travel bag, spare cables, charger adapter, sports band[3]. And also two electrodes, user has to buy regularly, and which are currently available in two kinds of packages: one package of two electrodes for 29.95$, or three packages of two electrodes for 89.85$[4].

A) A therapy pod, B) An electrode array, C) A Band, D) An example of usage on upper calf, place of effect[5]

Usage

Regardless which part of body is in pain, Quell is always placed on upper calf (no matter which side). The reason is that there is better contact with nerves, on which are impulses sent to medulla. After the devices is fastened around the calf, user needs only to press the button on it.

For easier control it is possible to download Quell application for iOS[6] or Android[7].

Principle

Electrodes should stimulate clusters of afferent senzoric nerves and this should trigger inhibition of pain in brainstem. Inhibition comes up due to cascade neurotransmitter release. This descending process starts in periaqueductal gray matter, continuing to medulla and then into spinal cord (its dorsal horn)[8]. Within-body-produced opioids, enkephalins, causes inhibition of pain signal transmission, while activate δ-opioid receptors. Company also claims, that Quell is as twice stronger as previous TENS pain relieving products, thus it doesn't have to be used locally, but only on an upper calf.

Official webpage depictures the process of how pain is blocked in medulla[9].

Purpose

Quell wearable is device designated for treatment of chronic pain, nerve deseases and disrupted sleep[10]. It works on principle of transcutaneous electrical nerve stimulation, which causes release of endogenous opiates affecting pain relief.

Company & People

Neurometrix is company directed on developing health-care wearable technology with main effort on sleep disorders, chronical pain, and nerve deseases treatment. The company, having a seat in Waltham Massachusetts, was founded in 1996 as a spinoff of the Harvard-MIT partition of Health Sciences and Technology.[11][12]

Currently Neurometrix offers four products in total[13]:

  • Quell™ - Wearable device for palliative purpose
  • SENSUS® - Therapy device available on prescription. It is based on TENS technology also for pain relief without any drug usage.
  • DPNCheck® - Nerve conduction test for evaluating systemic neuropathies such as diabetic peripheral neuropathy (DPN), its detection and monitoring.
  • ADVANCE™ NCS System - apparatus meant to assessing neuropathy diagnosis.


Directors of Neurometrix[14]:

  • Shai N. Gozani, M.D., Ph.D.
  • Allen Hinkle, M.D.
  • David E. Goodman, M.D
  • Timothy R. Surgenor
  • Nancy E. Katz
  • David Van Avermaete



Neurometrix stated also contact persons for media, which is Laura Wagstaff[15], and Thomas T. Higgins as contact person for investor relations[16].

Important Dates

1965 - Melzack and Wall proposed first conceptual model for mechanism which could lead to pain relief. They rationalized that harmful signals may be inhibited by peripheral afferents of large diameter.

1970s - Developement of TENS (Transcutaneous electrical nerve stimulation)

1996 - Establishment of Neurometrix

2014 - FDA gives a clearance to release Quell wearable device.

Ethical Issues

In present, there are no ethical issues known. It can be said that this is due to the fact that this Quell device's purpose is to provide lenitive care and also it is FDA cleared.

Health Risks

Official statement from Neurometrix about side effects is that there are none[1]. Usage is 100% drug free, with clearance by FDA (Food and Drug Administration) received in 2014. Despite the fact, that no side effects mentioned, there are some contradictions that patients with cardiac pacemakers or with implanted defibrillator should not use Quell, neither people with implated metallic or electronic devices. At least, patient should consult the using with a doctor. On the other hand no medication doesn't restrict Quell-using [17]. However, there are another information sources which discuss TENS technology. For example they claim, that TENS method is surely inexpensive and safe, but there are risk with using electrodes on damaged skin, or over area of malignancy [18], or it could trigger a seizure in epileptic patient in case that electrodes will be put near patient's head or neck[19]. Regarding these risks, most of them patients may avoid as Quell is used only on an upper calf.

Enhancement/Therapy/Treatment

Quell wearable device has primarily therapeutical function. Company states it was developed on purpose to palliate chronical pain which basically has origin in these four diseases:

However, diseases or illnesses are also identified as possible to be treated by TENS: Acute postoperative pain, primary dysmenorrhea, labor pain (which still remains controversial[20] ), post-stroke shoulder pain.

Although Quell was not created primarily to enhance cognitive or physical condition in humans, it may have secondary impact on physical and mental health (e.g. emotional stability, better memory) due to stress release, better sleep periods, and ability to be more concentrated if pain disappears. As a result should be quality of life enhanced generally.

Public & Media Impact and Presentation

Regarding business interests in presenting this product in public, and the fact that internet is anonymous space where we have no clue who is author of opinions or arguments, readers should consider that information found may be false or may be results of so called trolling. This concerns especially risks of possible health risks being hidden by promotion companies and institutions, further it could be individual people who could be paid for competitive malignment, or otherwise people praising a product untruthfully, or there may be people who just want to troll and thwart other project.

Official promotion

Products of Neurometrix are presented on the official Neurometrix websites, and also each of them has its own webpage. On internet is available also official launch video found right on the Quell product website. In the year 2014 Quell official facebook page was put into operation.


Other business promotion

There are some unofficial pages discussing Quell relief in point of view of business, technology, or healthcare. In their articles, it seems they use promotional rhetoric, without mentioning no scientificaly verified information (For example here on Humavox).


Could wearable Quell provide pain relief? on Detroit TV-channel WXYZ.

Individual opinion

Except of company's official presentation, many users share their experiences with the device on their blogs or Facebook posts, comments, ratings etc. BLog-contributors describe using Quell mostly as positive experience. Things the people are not satisfied with are e. g. unincluded insurance, hardly avalailable information, or expensive electrode which needs to be changed more than it is officially stated. Here, you can see examples of various blogs with articles dealing with Quell:

Public Policy

Quell received clearance from Food and Drug Administration, which is federal agency as part of Department of Health and Human Services. FDA is connected to the database on U.S. Government Publishing Office, Electronic Code of Federal Regulations (eCFR). This eCFR contains also of three chapters (I. Food and Drug Administration, Department of Healt and Human Services; II. Drug Enforcement Administration, Department of Justice; III. Office of National Drug Control Policy), where medical devices are sorted and classified according to specific properties, difficulties of usage, dangerousness, etc. It the chapter I, Quell description consists of a) identification and b) classification. Quell is kept under regulation number: 882.5890, and it is identified as "A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain"[21] . Further, it is classified with a "Class II (performance standards)"[22]. The latter category features most of medical devices (FDA stated 43%), including for example wheelchairs of pregnancy test kits[23].

Related Technologies, Project or Scientific Research

WINS Technology

TENS Research

It is possible to read one paper about Quell principles right on the official Quell website[24], but this doesn't contain necessities of independent scientific studies. Although there are no studies dealing with Quell product specifically, several independent researches about transcutaneous electric nervous stimulation were made. These studies seem to be not so unambiguous when speaking about good efficacy of TENS in treatment. Here follow few works engaged in TENS technology and its influence on different deseases.

Sluka and Walsh[25] summarize existing researches of TENS, and shows couple of results of scientific trials, and speak about equivocal effectiveness remaining due to low number of randomized and controlled trials.

Mark I. Johnson is author of a book about TENS[26]

References

  1. ↑ Shows if the device is a standalone wearable computer or if it needs to be connected to a processing unit to function.
  2. ↑ Quell wearable pain relief, starter kit, online shop webpage: https://store.quellrelief.com/products/quell-wearable-pain-relief
  3. ↑ Quell, Accessories, Online shop webpage: https://store.quellrelief.com/collections/accessories
  4. ↑ Quell, Electrodes, Online shop webpage: https://store.quellrelief.com/collections/electrodes
  5. ↑ Shai N. Gozani, Science Behind Quell™ Wearable Pain Relief Technology for Treatment of Chronic Pain: https://www.quellrelief.com/files/science-behind-quell.pdf
  6. ↑ Quell relief application available to download: https://itunes.apple.com/app/quell-relief/id972079954
  7. ↑ Quell relief application available to download on GooglePlay: https://play.google.com/store/apps/details?id=com.neurometrix.quell
  8. ↑ Introducing Quell™, a 100% drug free technology proven to fight pain: https://www.quellrelief.com/files/Quell%20HCP%201%20page%20(3).pdf
  9. ↑ Introducing Quell, a 100% drug free technology proven to fight pain: https://www.quellrelief.com/files/Quell%20HCP%201%20page%20(3).pdf
  10. ↑ Neurometrix, Company overview: http://www.neurometrix.com/about-neurometrix/company-overview.html
  11. ↑ Neurometrix, Company overview: http://www.neurometrix.com/about-neurometrix/company-overview.html
  12. ↑ NeuroMetrix Launches Quell™ Wearable Pain Relief Technology: http://www.businesswire.com/news/home/20150615005489/en/
  13. ↑ Neurometrix, Company overview: http://www.neurometrix.com/about-neurometrix/company-overview.html
  14. ↑ Neurometrix, Board of directors: http://www.neurometrix.com/about-neurometrix/board-of-directors.html
  15. ↑ NeuroMetrix Launches Quell™ Wearable Pain Relief Technology: http://www.businesswire.com/news/home/20150615005489/en/
  16. ↑ NeuroMetrix Launches Quell™ Wearable Pain Relief Technology: http://www.businesswire.com/news/home/20150615005489/en/
  17. ↑ Quell relief official website, Clinicians: https://www.quellrelief.com/clinicians
  18. ↑ Searle, R.D., Bennett M.I., Johnson M.I., Callin S., Radford H., Letter to editor: transcutaneous electrical nerve stimulation (TENS) for cancer bone pain. Palliat Med, 2008; 22 : 878 - 9
  19. ↑ Jones, Iain, Johnson Mark I., Transcutaneous electrical nerve stimulation, 2009
  20. ↑ Sluka KA, Walsh D., Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness, in: Journal of Pain, 2003, p. 109-121
  21. ↑ Code of Federal Regulations, Title 21, Volume 8, 21CFR882.5890 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRsearch.cfm?FR=882.5890
  22. ↑ Code of Federal Regulations, Title 21, Volume 8, 21CFR882.5890 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRsearch.cfm?FR=882.5890
  23. ↑ Medical device classification list on: http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm
  24. ↑ Science behind Quell, in: https://www.quellrelief.com/files/science-behind-quell.pdf, version 8/12/2015
  25. ↑ Sluka KA, Walsh D., Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness, in: Journal of Pain, 2003, p. 109-121
  26. ↑ Johnson, Mark I., Transcutaneous Electrical Nerve Stimulation (TENS): Research to support clinical practice, Oxford University Press, 2014, p. 272
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