Assisi Loop: Breakthrough or Woo?

[Amateur_Barbarian]

So I am browsing through the magazine published by our local animal rescue league (because I’m feeling slightly guilty about buying a breeder puppy, and maybe looking for a way to donate some time or help), and here’s a column by their vet tech advisor, about how incredibly wonderful the Assisi Loop is for treating wound healing and other persistent injuries in animals.

Put briefly, it’s a loop about a foot across with a sealed electronics box attached, that reportedly puts out magnetic pulses that enhance healing. It’s “FDA cleared” and only available by veterinary prescription, to the tune of $289 or so.

All of my woo detectors go off, full strength. So I start looking around. You can find quite a few reviews, mostly by veterinary techs (not vets, although there are a few) and the vast majority of which include a paragraph to the effect that “they were given a sample Loop in return for an unbiased review.” Most of the views rave in fairly extreme fashion and few contain anything like controlled study or comparisons.

So you go to Assisi Animal Health, which is a very sober and convincing website, and get the assurance that this is based on science and medical research, and they do have a list of abstracts reporting research in which magnetic pulses do seem to enhance healing, especially in stubborn cases like abscesses. There’s even a rather complex biochemical breakdown about the underlying theory of why it works.

So maybe this is a real breakthrough. But the alarms in my head, tuned by years of sensitivity to paranormal, alternative med and CT nonsense, still think there’s something suspicious here. So 'ave a look at the website and abstracts, google around to read some of the reviews, and weigh in…

[ul]
[li]Complete woo? (Probably not.)[/li][li]Complete breakthrough, heading towards new forms of treatment for both animals and humans?[/li][li]Or (my suspicion) six layers of woo on a small grain of scientific basis - either too small a sample or uncorroborated results, or a very specific treatment and trial expanded to generalities, or (again my suspicion) something achievable under lab conditions with relatively powerful and focused emitters but barely replicated by a sciencey-spacey-kewl-looking plastic ring with a beeper in it?[/li][/ul]

[running_coach]

The Effect of Magnetic Fields on Wound Healing
While the study had a good result, it is noted in the article that other studies had conflicting results.

Personally, I had a gadget after my accident that used magnetic fields to help heal the broken femur I had.
Can’t say if it helped or not, I had a partial non-union for 18 months with only minimal bone growth. It wasn’t until I could finally bear weight that the rate of healing the break increased and progressed to a full union.

[Amateur_Barbarian]

@running_coach

Personally, I had a gadget after my accident that used magnetic fields to help heal the broken femur I had.

Was that completely external, or did it use implanted receptors that generated current across the break? I’ve seen the latter (may be no longer used or obsolete).

[engineer_comp_geek]

I have never heard of any sort of electromagnetic fields being successfully used for healing, so I went googling. I found this wikipedia page, and about 3 pages of google woo.

Pulsed electromagnetic field therapy

While PEMF therapy may offer some benefit in the treatment of fractures, the evidence is inconclusive and is insufficient to inform current clinical practice.[9]

The wikipedia article says that it may be useful for bone healing and depression treatments, though consistent evidence for both uses seems to be a bit lacking. My google search makes it clear that whatever real effect might be there is buried under great big piles of steaming woo. According to the google hits, PEMF cures cancer and all kinds of stuff, none of which is even mentioned in the wikipedia page.

Here’s the wikipedia page on transcranial magnetic stimulation:

Transcranial magnetic stimulation

Evidence suggests it is useful for neuropathic pain[4] and treatment-resistant major depressive disorder.[4][5] A 2015 Cochrane review found not enough evidence to make any conclusions in schizophrenia.[6] For negative symptoms another review found possible efficacy.[4] As of 2014, all other investigated uses of rTMS have only possible or no clinical efficacy.[4]

[running_coach]

@Amateur_Barbarian

Was that completely external, or did it use implanted receptors that generated current across the break? I’ve seen the latter (may be no longer used or obsolete).

External. 2004. It looked generally like this unit.

[xizor]

My initial suspicion would be that if this worked at all, the company would make it for humans rather than animals, because of financial gain.

[engineer_comp_geek]

One thing that concerns me about the Assisi loop in particular is how thin the coil is. If you want to generate a decent electromagnetic field, you need a decent sized coil to do it. That thing looks more like a TV loop antenna, and I suspect that it’s going to generate a very weak electromagnetic field.

Compare that to how thick the coil is in running coach’s link. I’d expect to get a more substantial electromagnetic field out of a much thicker coil of wire like that.

[Czarcasm]

Yes, there are a number of peer-reviewed studies that the company touts…but the studies are for the general effect, not for their particular product, and all of the studies are for much larger strengths than can possibly be put out by their little loops.

[pieceoftheuniverse]

Anything that uses “magnetic fields” is probably woo. There was a big study in 2007 that basically debunked a lot of “scientific studies” with static magnet devices.

According to the same group that did the 2007 study, there’s no conclusive evidence that PEMF devices (like the Assisi Loop) have any tangible benefit.

I couldn’t find the Assisi Loop on the FDA website. The only thing I found was approval for Assisi Research Laboratories’ drug Asparaginase used “for the induction of remission of multicentric lymphoma in dogs.” Useful, certainly, but not particularly relevant. A search on “PEMF devices” came up with a lot of warning letters against another group for improper marketing of their device for things it has never been proven to actually do (for people, not for animals).

[Amateur_Barbarian]

@Czarcasm

…all of the studies are for much larger strengths than can possibly be put out by their little loops.

That was one of my specific questions - I could see something the size of a small cyclotron or MRI machine hitting a focused point with magnetic waves and possibly causing an effect, but a small, thin loop powered by small, sealed batteries good for 150 or more treatments? Uh-huh.

@pieceoftheuniverse

Anything that uses “magnetic fields” is probably woo.

I’d take that as a given, but I was willing to suspend judgment on the overall claim here.

I couldn’t find the Assisi Loop on the FDA website.

Well, “FDA cleared” is meaningless, no matter how much it looks like “FDA approved,” and could mean the FDA glanced at a submission and declined to issue any opinion.

Anyone else, maybe with some connections to what magnetic/electrical healing techniques are known to be valid in human medicine?

[Czarcasm]

The site claims that their loop gives a minimum of 150 15 minute electromagnetic therapy sessions from that little pendant hanging off the loop-. What the hell are they using for a battery source that is powerful enough to do all that, yet small enough to fit in that pendant with all the electronics that supposedly inhabit it?

[Riemann]

As others have said - electrotherapy specifically for wound healing is not woo. There is real evidence from scientific studies. The question really is how large the effect is for any device; and whether there is any evidence for this particular type of device.

If you’re interested in reading the research (on the general principle) yourself, usually the best way is to find the most recent study out there, because the citation list will then link back to everything else in the field. The most recent that I can find is fortunately on PLOS ONE, so it’s open access, see here:
Angiogenesis Is Induced and Wound Size Is Reduced by Electrical Stimulation in an Acute Wound Healing Model in Human Skin
And if you go down to “References” in that paper you will find a lot more material.

Of course, none of the above constitutes evidence that this particular device is anything but hokum, and if the best evidence this company has is giving samples to vets, I’d be extremely skeptical.

Re the FDA: so far as I can discern, although the FDA has authority to intervence, they do not in practice regulate veterinary devices, so “FDA cleared” is meaningless.
http://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm047117.htm

Pre-market Approval is Not Required: The FDA does not require submission of a 510(k) or formal pre-market approval for devices used in veterinary medicine. Firms that manufacture radiation emitting devices need to register their products under the radiological health regulations, administered by the Center for Devices Radiological Health (CDRH).

Device manufacturers who exclusively manufacture or distribute veterinary devices are not required to register their establishments and list veterinary devices.

FDA does have regulatory oversight over veterinary devices and can take appropriate regulatory action if a veterinary device is misbranded or adulterated.

It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices are safe, effective, and properly labeled.

[Riemann]

Taking a quick look through the 2015 study that I linked to above, here is the description of the device that was shown to have a signifcant effect on minor wounds in humans:

The electrical stimulation device used was the Fenzian system (Fenzian Ltd, Hungerford, UK) which is Food and Drug Administration (FDA) 510(k) registered and Conformite Europenne (CE) approved. It is a transcutaneous low intensity device, which detects changes in skin impedance. This device forms part of a biofeedback link with the individual’s normal physiological repair. This modality follows the theory that the normal electrical potential of skin forms a global electrical network, which reflects the underlying neurological activity through changes in skin impedance. Using a concentric electrode the device detects the skin’s electrical impedance and adjusts the outgoing microcurrent electrical biofeedback impulses. The device produces the degenerate waves and delivers 0.004 milliamps, 20–80V, has a frequency default of 60Hz and impulses, which last approximately six-hundredth of a second.

[Czarcasm]

@Riemann

Taking a quick look through the 2015 study that I linked to above, here is the description of the device that was shown to have a signifcant effect on minor wounds in humans:

That totally sounds just like a lightweight necklace and pendant that can operate off of a watch battery. :rolleyes:

[Riemann]

@Czarcasm

That totally sounds just like a lightweight necklace and pendant that can operate off of a watch battery. :rolleyes:

But… but… electromagnetism! Quantum epigenetics!

[Czarcasm]

@Riemann

But… but… electromagnetism! Quantum epigenetics!

Leaving aside all the woo science involved, can someone with the proper background tell me if it is possible for that device to put out the 150(at a minimum) 15 minute long electromagnetic therapy sessions that they claim their device is capable of? it doesn’t charge up, and the internal battery can’t be replaced.

[Amateur_Barbarian]

@Czarcasm

Leaving aside all the woo science involved, can someone with the proper background tell me if it is possible for that device to put out the 150(at a minimum) 15 minute long electromagnetic therapy sessions that they claim their device is capable of? it doesn’t charge up, and the internal battery can’t be replaced.

I’m thinking it has nothing much more in it than a timer and buzzer, so it beeps or buzzes when activated, and again 15 minutes later, and the battery wires run through the loop.

I’d love to lay hands on one and measure any field it might generate.

I started with a grain of consideration for this product, and now I’m thinking about those phenomenally expensive bomb detectors some company sold the US Army… which had nothing but plastic bits in a high-tech dowsing rod.

And okay, it’s not little kids or humans of any kind… but preying on desperate pet owners isn’t a whole lot less morally acceptable.

[Riemann]

The ironic thing with weak electromagnetic fields is that the conspiracy theorists and the alt-med woo peddlers are *both *so excited about them. Cellphones and cell towers cause cancer, throw away your cellphones and wrap your head in foil; at the same time, electrotherapy cures cancer, and just about eveything else, provided of course that it is applied holistically.

I imagine that there must be a huge market for holistic cellphones.

[Amateur_Barbarian]

How odd… I entered a specific thanks to Riemann for all the focused info, and must have forgotten to hit Post. Thanks for all the good anchors.

[Isilder]

@engineer_comp_geek

One thing that concerns me about the Assisi loop in particular is how thin the coil is

How’s it meant to work anyway ?
Increase cell respiration by pushing the ion channels faster ? But pushing the one direction of ion channels ( eg the east ones_ faster stops others (eg the west ones) as the ones in the opposite direction would be pushing against the applied field…