The Exogen 4000 is a LIPUS device -- Low Intensity Pulsed UltraSonagraphy. It comes with a) a strap with a little hole in it; b) the unit, which has a black circular transducer attached by cord, and c) two bottles of gel (which is WAY too much). It comes with a limited # of "charges" (more on that later), with each charge being a 20 minute session of ultrasound treatment to your injury.
It's remarkably easy to use. Detailed instructions are here, but basically you strap it to the location of your injury, and push the one and only button on the device. Once you do this, it runs through a system check, cycles screens showing how many times you've used the device, and then confirms that it's actually in contact with your body and has conductivity. If it doesn't have a connection, then it turns off without expending a charge, which is nice for those times when your cat accidentally (or intentionally) steps on the button.
Then it starts its work, counting down from 20:00 to 0. You don't feel a thing. At the end of the 20:00, it beeps to let you know it's done. You remove it, clean off the gel, and put it away. Putting on the Aircast afterwards is more difficult than this thing.
How It Works:
To the best of my limited understanding, the device, by pulsing ultrasound from the transducer, applies a stimulus that causes the "upregulation" of genes, promoting faster action by the body's healing processes, including removal of dead tissue and growth of new bone, capillaries, etc. Smith & Nephew's discussion of this process is here. I'm not quite sure what "upregulation" is, but it sounds effective, and I suspect that there are politicians that oppose it.
The area of the pulse is supposedly about 2.5 times the size of the transducer (which is in the shape of a quarter, and is approximately a centimeter thick). So, you don't have a large area of effect, and you need to get the transducer as close to the fracture as possible. For this reason, the Exogen is best used on bones that are close to the surface; and those who are larger may be more limited in the areas of the body where the Exogen will be effective. And if you have a cast, you'll have to have a window cut within your cast.
The clinical trials all were based on one use per day, and so that's what the recommendation is. I've heard from different sources that most sales reps recommend using it twice a day, spaced as evenly as possible (the idea being that you apply the stimulus, and then allow the body to react, so it doesn't make sense to queue up your uses back to back). As I note below, I used mine 3 times a day, at 8 hour intervals, with no ill effect.
The Exogen 4000 comes with a guaranteed 150 uses, aka "charges", according to their patient brochure (link to pdf). In practice, you can likely get many more -- I'm currently on use 200, and I've read reports of others getting 250 or more uses. But, you can only count on 150, so you want to be judicious in your use of the device. I do note that the PDF linked above implies that you can send the device back to Smith & Nephew for more charges if you're still healing your injury, but my sense is that that only holds true if you buy the device directly from S & N (as opposed to the Ebay/Craigslist option).
I also understand that the battery life is also limited by time, with approximately a year of battery life before the device fails. Mine is still going strong, but since it was manufactured in 2/10, I'll be putting battery life to the test shortly.
As a general rule, insurance companies have different criteria for whether they'll cover LIPUS, based on whether your fracture is fresh, or some time has passed since your fracture. Quite a few insurers post their coverage memoranda on-line, so that you can dig it up (albeit with some effort). Here's a few that I found. I do note that many distinguish between "fractures" and "stress fractures" - I'm not sure what the criteria is there.
- Anthem - For fresh, they'll cover fractures of the middle of the tibia, a "Colles Fracture" of the wrist, closed fractures that are at high risk for non-healing due to vascular issues and soft tissue/vascular damage, and closed fractures for people that are at "high risk", including smokers, diabetics, anemics, steroid users, the obese, the nutritionally deficient, and alcoholics. Yes, there's a bit of irony here, as well as disappointment that training-obsessed runners aren't considered high-risk.
Otherwise, if you wait 45 days and your fracture hasn't progressed, and you meet certain other criteria, they may cover. Stress fracture? Specifically excluded.
- BCBS-Delaware - looks like they'll cover fresh closed fractures, as well as fractures that have shown no sign of healing for 3 months (except for skull and spine, and see other limitations). They don't cover stress fractures.
- Cigna - for fresh, they'll cover fractures of the middle of the tibia, a "Colles Fracture" of the wrist, or closed fractures where there's a high risk of not healing due to either poor blood supply or "comorbidities" like "smoking, diabetes, renal disease, or other metabolic disease where bone healing is likely to be compromised". If you've gone more than 3 months without healing, and it's not your skull or vertebrae, then they may also cover it (see other conditions). If your stress fracture has gone 90 days without healing, but can be seen by imaging, they should cover as well.
Well, the answer is actually pretty obvious. EBAY! There's generally at least 20-30 of these babies up for sale at any time. And it's really not that bad a deal.
The Exogen 4000 is generally priced at about $4000 to the insurers -- if you have a 10% copay for durable medical equipment, that's $400 out of your pocket. Of course, in exchange for that, you get a brand new device that's under warranty, and the peace of mind that comes from supporting our nation's pharmaceutical/medical research industry.
Or, there's the world of online auctions - the devices seem to be priced for about $200-400 on eBay. You are taking a risk by buying a used device online, but at least the hit to your pocket will be the same or less. There is an excellent guide to buying these things on eBay that is worth reading. I will briefly note two things to look for/ask about:
- The number of charges left on the device. As noted above, these do come with a limited # of charges. You should be able to assume 150 charges; you may get many many more out of the specific device, but why risk it by buying a device with 145 charges? The seller should be able to provide a photo of the start up screen showing the number of full and half uses -- if s/he doesn't, I'd buy elsewhere.
- The age of the device. Supposedly, these have a limited shelf life too -- the battery ages. Also, there was a FDA recall on these in 2008-2009; it's probably a good idea to avoid those. You can identify the age of the device clearly by the serial #, as explained here. Again, if the seller won't provide the serial #, don't deal with him/her.
On November 3, I was diagnosed with a traumatic spiral fracture of the second metatarsal on my left foot -- the fracture clearly showed on x-ray, and was NOT a stress fracture as traditionally seen (stress fractures have a gradual onset, are splintery rather than a clean break, and often don't show on x-ray; mine was a sudden clean fracture that was immediately visible).
My podiatrist recommended this device pretty strongly, and placed me in touch with a representative from Smith & Nephew who was charged with trying to get my insurance to cover the device for me. After 3-4 days passed without her returning my calls, and I had confirmed via my own research that my insurance was very unlikely to cover, I went the eBay route, and purchased one with 29 uses on the counter for $340, plus $20 to overnight it.
As noted above, the official literature recommends that you use the device once a day; I had read multiple comments on various message boards indicating that sales reps advise to use it twice a day. When I asked my podiatrist how often to use, he responded "the more the better."
With that advice in mind, I used three times a day, with 8 hour intervals -- 5:00 am, 1:00 pm, and 9:00 pm. I would fudge the exact timing a bit -- sometimes 1:00 pm would be 12:30 or 1:30 -- but I consistently used it three times a day seven days a week up until the day I was told the bone was healed, and I was cleared to run.
Since them, I've still been "zapping" my foot once a day -- I don't know whether this is accomplishing anything, but it can't hurt.
I was originally projected for 12 weeks before the bone would be healed sufficiently to run; in the end, I was cleared to run at 7 weeks. This is consistent with the "best case" predictions for results of a 38% reduction in healing time (patient brochure pdf, p.26).
Can I be sure the bone stim reduced my healing time? No. There's no way I'll ever know. But I think my $360 was money very well spent, and I'd make the same decision the next time around.
Addendum - some interesting links: