Quell relief

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 is 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. The technologie of TENS is not new, but it was developed on knowledge about possibility to heal with electricity, which was described already in 19th century. In the beginning of 21th century, Quell device was constructed and it needs to be put into analysis of its technology, marketing strategies and usefulness, regarding human enhancement and therapy.

QUELL RELIEF
Category	Therapeutic wearables
Developer	NeuroMetrix
Announced	Oct 2015
Released	Consumers: 2015
Price	249 USD
Weight	62 g
Dimensions	98x75x11 mm
Controls	smartphone
Standalone
https://www.quellrelief.com/product

Main characteristics

Components

The basic product a customer can buy, called Quell wearable pain relief - starter kit, includes one piece of Quell device, adjustable sports band, charger cable, and charger adapter, and two 2 electrodes (company claims one month supply). Manual is available to download in the Quell-user category, in English, and Spanish language.

User have to buy accessories in addition like travel bag, spare cables, charger adapter, sports band. 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$, or three packages of two electrodes for 89.85$.

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

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 or Android.

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). 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.

Purpose

Quell wearable is device designated for treatment of chronic pain, nerve deseases and disrupted sleep. 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.

Currently Neurometrix offers four products in total:

• 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:

• 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, and Thomas T. Higgins as contact person for investor relations.

Important Dates

Important dates in history of TENS:

• 1759 - John Wesley described medical usage of electricity for sciatica, headache, gout, and kidney stones treatment.

• 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)

• 2007 - Johnson and Martinson - Largest meta-analysis of evidences about three times stronger pain relief than in placebo.

Important dates of Quell device history:

• 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) and any long-term consequences in human organism are not know.

Speculatively, it might happen that palliative treatment will lead only to pain elimination but not causation cure, which could cause some grave injury. Let's consider, in a case of scoliosis, some physical workout could help to strenghten the back muscles and thus to stop a back pain. Pacients with any continual body-pain should take in consideration if there are any ways to cure cause of pain first. This discussion is based on some videos and comments of people using Quell just on scoliosis.

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 . 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 , or it could trigger a seizure in epileptic patient in case that electrodes will be put near patient's head or neck. Regarding these risks, most of them patients may avoid as Quell is used only on an upper calf. Nevertheless we should wait for some new quality scientific trials and longe to show if Quell device brings some currently unknown specific healthy risks.

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:

• Painful Diabetic Neuropathy (PDN)
• Fibromyalgia
• Osteoarthritis
• Sciatica

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 ), 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.

Company promotion

Products of Neurometrix are presented on the official Neurometrix websites, and also each of them has its own webpage. It is question to which extent can be this website trustworthy or customer-friendly, regarding these reasons: First thing is untransparency of information - despite of minimalistic and light design, it takes longer time to find technical parameters or principles of mechanisms. Second thing is absence of ethical aspect of Quell device. It would be respectable if customers could see that company is interested in such an issues as well. Thirdly, website lacks references to independent scientific studies which would criticaly evaluate the device's mechanism.

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, and it's still active, also its administrators shows some will to answer on users' questions and to share new information with them. Quell has also its own youtube channel, however, it contains only one video and otherwise this channel seems to be currently not active.

Other official 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.

Many advertising videos and testimonials are to be found on youtube. Here are some examples of them:

• https://www.youtube.com/watch?v=QJmgStBUPpw

• https://www.youtube.com/watch?v=PAPEMVWIRIY

• https://www.youtube.com/watch?v=7uZcRvuf9Vs

• https://www.youtube.com/watch?v=9vbLGVXIfvI

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. Only health issue found was nausea, although pacient claimed pain reduction (see picture below) - this claim is actually the only one which neither Quell site, nor dr. Shai Gozani has responded on.

Pacient's experience with Quell device. He claims he feels improvement but also nausea. Official facebook page

Here, you can see examples of various blogs with articles dealing with Quell:

• Quell: Relief From Chronic Pain

• CES Dispatches: Pain-Relieving Device for Diabetic Neuropathy

• Quell, is it?

Although the majority of videos on youtube are made by channels and companies which are paid for it, still some individual user's manual- or testimony-like videos can be found as well, e. g. here, where the user confess no affiliation with the company: https://www.youtube.com/watch?v=BHI7PSxXbSw

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" . Further, it is classified with a "Class II (performance standards)". The latter category features most of medical devices (FDA stated 43%), including for example wheelchairs of pregnancy test kits.

Related Technologies, Project or Scientific Research

TENS Research

It is possible to read one paper about Quell principles right on the official Quell website, 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 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. Sluka and Walsh quote that different trials for one disease may have contrasting results, as in case with treating labor pain.

Mark I. Johnson is author of a book supporting TENS technology..