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The Cefaly device for migraines...anyone use this??

Hi guys! I just heard that the FDA approved the usage of The Cefaly in the US yesterday. You have to have a prescription to get it. Wonder if insurance will cover it and when it will be available here in the US.

http://www.fda.gov/NewsEvents/Newsro.../ucm388765.htm

For anyone that has used this, has it helped? Can you share the device with your child who gets awful migraines too? (yes, he is over 8) I have RSD/CRPS throughout most of my body, including the right side of my face...wondering if I ccould use this...

I appreciate any input. I have been suffering from migraines since I was a kid and am now 47. Cannot tolerate any of the migraine meds any longer, even allergic to botox (bummer because it really helped).

Thank you!
Nanc

Quote:

Originally Posted by Nanc (Post 1056585)

Can you share the device with your child who gets awful migraines too? (yes, he is over 8)

Don't know if the above is a typo, but the artical says

Quote:

Cefaly is indicated for patients 18 years of age and older

As a prescription device, I would think it would only be intended (legal) for the person it was prescribed for. Depending on how it works, settings might be different for different individuals. OTOH, goggle shows it's already being sold on Amazon, and at Costco in Canada.

http://www.amazon.com/Default-10102-...pr_product_top

Here are the customer reviews there:

http://www.amazon.com/Default-10102-...ews/B004DLTZU8

Doc

Quote:

Originally Posted by Dr. Smith (Post 1056591)

Thanks for the link; this is the first I've heard of this device. First off, I'm wondering why someone couldn't use a regular TENS device in a similar way. (It wouldn't surprise me if this is how the idea for it came about).

Don't know if the above is a typo, but the artical says

As a prescription device, I would think it would only be intended (legal) for the person it was prescribed for. Depending on how it works, settings might be different for different individuals. OTOH, goggle shows it's already being sold on Amazon, and at Costco in Canada.

http://www.amazon.com/Default-10102-...pr_product_top

Here are the customer reviews there:

http://www.amazon.com/Default-10102-...ews/B004DLTZU8

Doc

Hey Doc. It is pretty much a TENS unit...I wonder how it differs from a standard TENS. Maybe the application of it is easier?? Here is the website: http://www.cefaly.ca

I do see where that press release does say that it is indicated for ages 18 and older. The Cefaly website is where I got the age 8 and older from...sorry for that confusion.

I googled it as soon as I saw it on the Nightly News last night and saw those Canadian sites (Amazon and Costco). Pretty good reviews I thought. Thanks foe linking them.

I am very curious about this....

Quote:

... migraine headaches are less frequent, less painful, and simply disappear.
http://www.cefaly.ca/

emphasis mine

...while the 67 patient study showed:

Quote:

The device ... did not reduce the intensity of migraines that did occur.
http://www.fda.gov/NewsEvents/Newsro.../ucm388765.htm

For us (migraine patients), any improvement is good news, but if any claim is/can be brought into question, that casts doubt/raises questions about any/all claims.

I also noted that...

Quote:

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.
Ibid.

So while about half were satisfied, about half weren't satisfied (i.e. convinced). :rolleyes:

My take on it at this time is... A decent TENS unit can be gotten for <$100, with a lot more versatility than Cefaly @ ~$250-$400. I'm sure the high pricetag is due to patent and the sellers hoping insurance will pick up the tab. From what I know about electronics, a fair/reasonable (and still profitable) price would be more like $25-$40, which I think more people would be willing to take a flyer on, on basically a 50/50 proposition. Many will wait until someone figures out how to use a regular TENS unit for the same effect, or until TENS mfrs. include migraine settings/options on their units (which I'm guessing won't be very long). :Ponder:

Doc

Quote:

Originally Posted by Dr. Smith (Post 1056682)

I don't know if the age discrepancy is an error in the press release or if the FDA is taking a conservative stance and only approving it for adults at this time. :Dunno:

Another discrepancy I noticed (which IMO is material) is that the company website claims...
emphasis mine

...while the 67 patient study showed:

For us (migraine patients), any improvement is good news, but if any claim is/can be brought into question, that casts doubt/raises questions about any/all claims.

I also noted that...

So while about half were satisfied, about half weren't satisfied (i.e. convinced). :rolleyes:

My take on it at this time is... A decent TENS unit can be gotten for <$100, with a lot more versatility than Cefaly @ ~$250-$400. I'm sure the high pricetag is due to patent and the sellers hoping insurance will pick up the tab. From what I know about electronics, a fair/reasonable (and still profitable) price would be more like $25-$40, which I think more people would be willing to take a flyer on, on basically a 50/50 proposition. Many will wait until someone figures out how to use a regular TENS unit for the same effect, or until TENS mfrs. include migraine settings/options on their units (which I'm guessing won't be very long). :Ponder:

Doc

Great points Doc. I agree with you!!
Thanks for your detailed replies :)
Nanc

My TENS unit instructions said to not use it on the head. Don't know why though.

I used it on my neck for the horrible pain and tightness I get with my migraines this past week. I've used it before, but sometimes I put it away and totally forget about it :Doh:

I have TMJ too and was thinking it would be good for my jaw.

Now that I finally have insurance again and can go to the doctor I plan to ask them about it.

Quote:

My TENS unit instructions said to not use it on the head. Don't know why though.

My offhand guess would be what the FDA has approved the unit for, but I could be wrong.

IME, doctors don't know a lot about TENS units; they tend to leave that up to physical therapists, but it can't hurt to ask.

I don't know how old your TENS unit is. Mine says don't cross the spine, yet a friend's unit comes with specific instructions & pads to cross the spine.

There are obviously different units with different features & modalities, and technology moves on. I wouldn't recommend doing anything anyone's unit says not to do; my previous comments were more in the way of future speculation.

Doc