Skip to main content

Non Drug Pain Management Ideas: Introducing Cefaly!


A medical device for the prevention and treatment of migraine has been approved by the FDA. It is a battery powered device, shaped like a headband...it has been available in some other countries prior to its release in the US.  Here is a video demo and the FDA new release for this product.

 

 

FDA NEWS RELEASE

For Immediate Release: March 11, 2014
Media Inquiries: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA allows marketing of first medical device to prevent migraine headaches 

Today, the U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.
“Cefaly provides an alternative to medication for migraine prevention,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.”
Migraine headaches are characterized by intense pulsing or throbbing pain in one area of the head, accompanied by nausea or vomiting and sensitivity to light and sound. A migraine can last from four to 72 hours when left untreated. According to the National Institutes of Health, these debilitating headaches affect approximately 10 percent of people worldwide and are three times more common in women than men.
Cefaly is a small, portable, battery-powered, prescription device that resembles a plastic headband worn across the forehead and atop the ears. The user positions the device in the center of the forehead, just above the eyes, using a self-adhesive electrode. The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches. The user may feel a tingling or massaging sensation where the electrode is applied. Cefaly is indicated for patients 18 years of age and older and should only be used once per day for 20 minutes.
The FDA reviewed the data for Cefaly through the de novo premarket review pathway, a regulatory pathway for generally low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.
The agency evaluated the safety and effectiveness of the device based on data from a clinical study conducted in Belgium involving 67 individuals who experienced more than two migraine headache attacks a month and who had not taken any medications to prevent migraines for three months prior to using Cefaly, as well as a patient satisfaction study of 2,313 Cefaly users in France and Belgium. 
The 67-person study showed that those who used Cefaly experienced significantly fewer days with migraines per month and used less migraine attack medication than those who used a placebo device. The device did not completely prevent migraines and did not reduce the intensity of migraines that did occur.
The patient satisfaction study showed that a little more than 53 percent of patients were satisfied with Cefaly treatment and willing to buy the device for continued use. The most commonly reported complaints were dislike of the feeling and not wanting to continue using the device, sleepiness during the treatment session, and headache after the treatment session.
No serious adverse events occurred during either study.
Cefaly is manufactured by STX-Med in Herstal, Liege, Belgium.


Sources: FDA, YouTube/Cefaly Technology

Comments

Popular posts from this blog

Living with Chronic pain hits the big screen!

Been to the movies lately?  Jennifer Aniston is on the big screen in a recent release titled "Cake." Her character, Claire is a victim of chronic pain...she belongs to a support group, where all of the members are coming to terms with the suicide of one of their members.  Of course, she also takes pain medication and addiction is another of her problems...and of course there's more! I guess I am writing this post just to bring readers' attention to the fact that Hollywood has become aware of the crisis that is chronic pain.  This movie is a testament to that. People that don't have to live with this kind of pain don't fully understand the whole story.  Maybe this movie will shed some light on the issues. Here is the official trailer for the movie: Sources: prweb;NorthJersey.com;YouTube

Sciatica: A common pain in the butt!

Sciatica pain results from pressure or damage to the sciatic nerve.  This nerve originates in the spine and runs down through the buttocks and the back of the leg...so if you've ever literally had a pain in the butt, it is possible that sciatica is the problem.  The cause of the pressure can be from a number of sources...for instance,  compression in the spinal cord due to disc injury or a tumor. The sciatica pain sensation can vary widely..it can present as a numbness or tingling, dull ache, burning, and in severe cases the pain can make movement quite difficult. Over time, it is possible for sciatica to resolve on its own.  If it does not, it is important to seek medical help to determine the root cause of the pain. The usual first course of remedies for sciatica include ice application to the affected area for the first 48-72 hours, followed by heat.  Over the counter pain medications such as acetaminophen or ibuprofen are also appropriate.  Bed rest is not recommen

The Multimodal Approach to Pain Management

OK..so if you've been following this blog you will notice that there are a good number of ideas to help manage chronic pain.  You might ask yourself, "Which one of these ideas is best for me ?" I would suggest that you might try any number of these things, depending on your level of ability/disability, health care team recommendations, and your personal interests.  There are a number of reasons for doing this: 1) The patient is in control..with few exceptions, it is your decision what to try/not try and how many different things you want to experiment with at any time. 2) Non drug pain management ideas do not have any of the drug interactions or side effects that medications have.  You may have to set limits or modify activity according to personal circumstances, but usually it does not hurt to try any of them. 3)You usually do not need a prescription for most of the ideas I have described.  There are a few exceptions, such as physical therapy.  There is no wait