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Laser therapy
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Laser therapy - March 30, 2006 9:50:00 AM
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truthseeker
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Does anyone know much about laser therapy? I am reading more and more about it but it is all, or almost all, from sales pitches. I really don't know even what the rationale is for its supposed effectiveness. My current PT student plans to go to a seminar next weekend by Chukuka Enwemeka PhD PT to learn more and share with us the following week. Any thoughts??
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Re: Laser therapy - March 31, 2006 7:55:00 PM
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JDMBBuilder
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dr enwemeka is the dean at my school...
there are some studies that support it...but not too many rct's
_____________________________
"Anyone can throw you on a "state of the art" machine and call it physical therapy. The only high-tech equipment I need are my brain and two hands..." -JSDPT
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Re: Laser therapy - April 1, 2006 3:18:00 AM
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Andrew M. Ball PT PhD
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Before examining articles, it's important to know what laser therapy is generally used for, and why. Most (but not all) of the time, it's used for wound healing and/or diabetic peripheral neuropathy. In the non-diabetic patient, Calcium interacts with L-Arginine to produce NOs (nitric oxide synthase). The NOs is activated into –NO, which fuels the capillary vasodilatation cascade (NO combines with Fe++/Guanylate Cyclase to form cGMP. cGMP is the actual biochemical that drives capillary vasodilation). In the diabetic patient, however, increases in blood sugar levels result in almost immediate inactivation of NO via two mechanisms. First, increased free radical levels (O2) results in an increased level of interaction with –NO to form NO2. NO2 does not have the vasodilator effect of NO. Second, any NO that doesn’t end up as NO2 ends up tightly bound to Red Blood Cells (RBC’s) so it can’t easily be released to cause vasodilatation and a resultant increase in blood flow. The bond between NO and the RBC seems to be stronger in diabetics than non-diabetics. Peripheral vasodilatation, therefore, does not occur and peripheral nerves are choked of their blood supply --- ultimately, this leads to the symptoms of pain and loss of sensation associated with DPN. In addition, patients with diabetes (type 2 diabetes specifically) appear to be less capable of converting L-arginine into NO. Anodyne laser therapy severs the bond between NO and the RBC’s, releasing the NO into the bloodstream where it exerts its effect upon the capillary walls --- resulting in vasodilatation and restoration of blood flow and nutrients to sensory nerves. Patients with plantar pain and compromised protective sensation generally realize cumulative improvements in both pain and sensation over the course of 6-12 Anodyne treatments. 66% of patients realize a full restoration of protective sensation, 71% realize sensory improvement (e.g. an additional 5% realize incomplete sensory improvement).
Dr. Andrew M. Ball, PT, DPT, PhD
Physical Therapist
REFERENCES
Leonard DR, et al. Restoration of Sensation, Reduced Pain, and Improved Balance in Subjects With Diabetic Peripheral Neuropathy: A double-blind, randomized, placebo controlled study with monochromatic near-infrared treatment. Diabetes Care. 21(7), 2004. In this sham-controlled, double-blind study of twenty-seven patients (9 of whom were insensitive to the 6.65 Semmes Weinstein monofilimant (SWM) and a modified Michigan Neuropathy Screening Instrument (MNSI), and 18 who were sensitive to the 6.65 SWM but insensitive to the 5.07 SWM) were studied. Each lower extremity was treated for 2 weeks with sham or active Anodyne Therapy System (ATS), and then both groups received active treatments for an additional 2 weeks. The group of 18 patients who could sense the 6.65 SWM but were insensitive to the 5.07 SWM at baseline obtained a significant (decrease from an average of 3.5 to 1.9 insensate points), decrease in the number of sites insensate after both 6 and 12 active treatments. Sham treatments did not improve the sensitivity to the SWM(4.0 insensate points), but subsequent active treatments did (3.7 insensate points). Pain reported on the VAS decreased progressively from 4.2 at entry to 3.2 after 6 treatments and 2.3 after 12 treatments. At entry, 90% of subjects reported substandial balance impairment; after treatment this decreased to 17%. Given the ease of administration of standardized balance tests such as either the BERG balance test or the Timed Up and Go, it is unclear as to why the authors used no more than a subjective question to monitor improvements in balance. Among the nine patients with greater sensor impairment measured by insensitivity to the 6.65 SWM at baseline, improvements in sensation, neuropathic symptoms, and pain reduction were not significant.
DeLellis SL, Carnegie DH, Burke TJ. Improved Sensitivity in Patients with Peripheral Neuropathy: Effects of Monochromatic Infrared Photo Energy. J Am Pod Med Assoc. 95(2), 2005.
In a retrospective analysis of 1047 patient files of patients with diabetic peripheral neuropathy using monochromatic infrared laser treatment, 66% of patients fully restored protective sensation and an additional 5% reported an improvement in protective sensation. Directly applicable, but a lower level of evidence than the double-blind, randomized, placebo controlled study conducted by Leonard DR, et al.
_____________________________
Dr. Andrew M. Ball, PT, DPT, Ph.D.
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Re: Laser therapy - April 1, 2006 4:32:00 AM
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jma
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Thank you for the information and the specifics. An interesting modality.
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Re: Laser therapy - April 1, 2006 5:06:00 AM
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Tom Reeves DPT ATC
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Wow, thanks Drew, that was more than I expected. Now I have to review my biochem.
Tom
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Re: Laser therapy - April 1, 2006 5:23:00 AM
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SJBird55
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Except, reality is that the sales reps tend to paint a wonderful picture that their product treats every "itis" and "osis" within pretty much every body part with great success...
Drew, maybe the reason that standardized balance tests were not used in the study had to do with the simple fact that the researchers were not aware of any. Also, it just looks to me that the researchers may have been more focused on altered sensitivity versus functional change. An increase in protective sensation could potentially lead to a reduction in amputations. They may not have technically realized importance of sensation in regard to balance. I would be more willing to bet that function/balance was definitely not the main focus.
I can't remember exactly what I recently read, but there are a couple of questionnaires that ARE pretty good at capturing whether a patient will demonstrate balance deficits via the Berg and the TUG. I can't remember which was better, but for some reason I'm thinking the ABC scale, which I think is the activity-specific balance confidence scale. I don't even remember the other tool's name. I researched both tools 3-4 years ago and discovered that the ABC suited my population better.
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Re: Laser therapy - April 1, 2006 5:45:00 AM
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tucker
Posts: 182
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From: Texas
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What? Anodyne is not laser therapy..it is infrared and the recent studies are not favorable when compared to sham anodyne in improving sensation for diabetic neuropathy. They were also slapped by the FDA a few months ago for not reporting several superficial burns and marketing for things not covered with the FDA...which is only pain and circulation. Many of the studies that they show in the sales pitch are either poorly designed or have potential financial conflicts of interest.
Reference:
Clifft JK, Kasser RJ, Newton TS, Bush AJ. The effect of monochromatic infrared energy on sensation in patients with diabetic peripheral neuropathy: a double-blind, placebo-controlled study.1: Diabetes Care. 2005 Dec;28(12):2896-900.
CONCLUSIONS: Thirty minutes of active MIRE applied 3 days per week for 4 weeks was no more effective than placebo MIRE in increasing sensation in subjects with diabetic peripheral neuropathy. Clinicians should be aware that MIRE may not be an effective modality for improving sensory impairments in patients with diabetic neuropathy.
The authors do a great job of discussing possible reasons why sensation improved with the placebo unit...Hawthorne effect or the patients become more aware of proper foot care with educational handouts.
Darin Trees, PT, DPT, CWS
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Re: Laser therapy - April 1, 2006 6:09:00 AM
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tucker
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From: Texas
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By the way. The Hawthorne effect was new to me and very interesting when compared with the placebo effect. Here is one definition:
The Hawthorne effect: simply of being studied. Aspects of this suggest that the effect did not depend on the particular expectation of the researchers, but that being studied caused the improved performance. This might be because attention made the workers feel better; or because it caused them to reflect on their work and reflection caused performance improvements, or because the experimental situation provided them with performance feedback they didn't otherwise have and this extra information allowed improvements.
Darin
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Re: Laser therapy - April 1, 2006 9:10:00 AM
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Andrew M. Ball PT PhD
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Correct me if I'm wrong Darrin, as you're the CWS and, I'm sure, have much more exposure and experience with Anodyne/MIRE than I do (I conducted my DPT case study on a patient with DPN, using a combination of Anodyne and Aquatic therapy) . . . I have thought that MIRE was emitted at a light wavelength that was excited, straight, unscattered and (by definition) L.A.S.E.R.
SJ --- My case study did show dramatic improvements with respect to BERG and TUG, but alas, a case study isn't exactly high level evidence. I'm currently in the process of an outcome study on the subject, and patients have improved dramatically with respect to the BERG and TUG. Type II patients seem to do better. Currently my co-author and I are in disagreement over how to examine the data (he thinks a % improvement is a sufficient way to report, while I think that a regression analysis or ICC is more telling esp. with respect to the difference between good-balance-pre-treatment patients and poor-balance-pre-treatment patients). I'm sure it will be kicked back upon submission for that reason, so I'm not putting up much of a stink about it now, and he gets sensistive when I try to calculate the regression from our data). If you're interested, I'll see what I can garnish without raising a stink.
As for the Anodyne and the FDA, I've not heard the full story, but burns ARE a risk, and I wouldn't put Anodyne over an active metastisis --- although the company is "iffy" on it's safety in that situation. Seems that it's "just a high-tech flashlight" in some instances, and a class II FDA device in others . . . but that's a topic for another thread.
Finally, the Clifft study that Darrin references is, to me as an evidence-based CLINICIAN, worthless. It is, in my opinion, silly to examine increases in sensation with the assumption that increases in sensation increase balance abilities when it's so much more functional (and easy) to measure balance in the first place! Does anodyne improve balance? My data supports that it does. Does anodyne decrease pain sufficiently to allow for patients to walk further? My data suggests that it does. This, in my opinion, is more functional, and more important, than a singular focus upon sensation. Also, the Clifft study examined (unless I'm thinking of the wrong study), protective sensation and discrimination only. I've seen many, many, patients that improve with respect to INSENSATE ZONE (e.g. the parasthesia "boot" moves further down the leg), accounting for improvement in balance and ambulatory tolerance --- but not sensation as measured by Clifft et al. To throw out MIRE because of the Clifft study is, in my opinion, an overgeneralization of the study, and not a particularly good use of the evidence-base or (my) clinical data.
Drew
_____________________________
Dr. Andrew M. Ball, PT, DPT, Ph.D.
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Re: Laser therapy - April 1, 2006 9:50:00 AM
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SJBird55
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Protective sensation is quite important in the population of folks with diabetes. Protective sensation has nothing to do with balance, but in my opinion, is an important characteristic that without protective sensation has a great potential of leading to an amputation for folks that do get injured and do not visually assess their skin intactness. It all depends on what one wants do do with the information learned. In the whole scheme of things, since CMS IS addressing diabetes and DOES have preventative stuff in place for this particular diagnosis, a lot of money is spent on care for individuals with diabetes. So, sometimes, what we as physical therapists may not find valuable does have value in the big scheme of things. Depending on the long term results of treatments that increase protective sensation, it may be common place in the future for patients to have those treatments for amputation prevention reasons... I don't know enough about the particular modalities - but I would be willing to bet (based on the current fee schedule) that it is probably a LOT cheaper to have a few of those treatments and have repeat treatments in the future if long term effects only last say 1 year? I haven't seen any research on long-term effects, but who knows... I'd still bet that if there were decent long-term effects, it could be probable that based on mortality rates and the frequency of amputations that it may be more cost-effective to do the passive treatment to reduce future costs. (Although, in my opinion, a mirror is a cheaper alternative that incorporates patient responsibility and accountability - although with patients with dementia that may not be realistic or for patients in the long term care facilities.)
Balance though, you know, balance is tricky. My thesis was on balance and there are a lot of components to balance. I'm not sure what your definiton of "dramatic" improvements with respect to BERG and TUG would mean, but because balance has variables at all sorts of levels, personally, I wouldn't choose to use just anodyne alone to address anyone with balance deficits. Sensation and proprioception are components of balance, so yes, improvement in that area would technically improve balance to a degree. To answer the sensation/balance question... you could probably look at your data to see if there was a correlation between the amount of sensation and the balance deficits present prior to treatment intervention and then any changes in either post treatment. And then, the only other thing that I'd question would be, what else occurred through the provision of physical therapy services? Technically, it is frowned upon to only provide a passive modality in the eyes of CMS. And, I'm also making the assumption that your main population is 65+, but at the same time I have no idea how large of an n value you have and then I would also question the current functional level of the population being tested... combined with whether there was a control group.
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Re: Laser therapy - April 1, 2006 10:47:00 AM
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Andrew M. Ball PT PhD
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From: Charlotte, NC
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SJ,
All good points. Anodyne is, of course, not used in isolation for the treatment of patients with DPN and balance difficulties. We're combining it with balance retrainiing land-based and in an aquatic medium (e.g. there is more than just one treatment group)
As for your other questions, Anodyne usually takes 6-12 visits to "work" depending upon the outcome desired, and the goal isn't to provide long-term relief, but rather to justify to Medicare that the modality works for the individual patient and that a home-unit may be indicated. Patients either get an opportunistic window to produce more NO due to greater ease with exercise and lifestle changes (which is less common), or return of symptoms (with a vengence) between 32 and 38 days after in-clinic treatment has ceased.
There are a few patients that get anodyne only, and considering that (according to my supervisor and fiscal intermediary) we only get $7 from Medicare for anodyne-only treatments, we usually take a loss in treating such patients --- but most of the time end-up with a strong patient advocate for our clinic (and physical therapy at large), and the diabetic patients usually return with frozen shoulders, etc. --- so in those cases it's more of a long-term investment in public relations.
Drew
_____________________________
Dr. Andrew M. Ball, PT, DPT, Ph.D.
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Re: Laser therapy - April 1, 2006 12:36:00 PM
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tucker
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From: Texas
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Here is the warning letter from the FDA:
http://www.fda.gov/foi/warning_letters/g5660d.htm
It was a good thing because the company claimed it healed or worked on everything. You must be skeptic when you hear that many claims. If it's too good to be true...
As for Clifft and colleague's study, it was looking at increasing protective sensation to prevent neuropathic wounds and later amputations as SJ mentioned. It did not address the balance claims. I just found it surprising that the sham group improved just as much as the active group. This definately requires further investigation by independent researchers before saying it 'works'.
Darin
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Re: Laser therapy - April 1, 2006 1:18:00 PM
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tucker
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From: Texas
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Drew,
Regarding the DeLellis study you cited, Burke works for the company as the 'Director of Research and Clinical Affairs'...that is the potential conflict of interest. The University of Tenn study I cited was an independent with the equipment supplied by the company. I am sure they did not like the results.
Darin
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Re: Laser therapy - April 1, 2006 1:27:00 PM
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SJBird55
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From: Michigan
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LOL Darin... if it's too good to be true... and I do know that when a sales rep walked into my clinic and started blah, blah, blahing about how wonderful their thing was and then I asked if there was any independent research to support the claims, the guy got pretty quiet. And, then when I told him that all I read had to do with patient's with sensory loss secondary to diabetes, he got even quieter. I then looked him straight in the eyes and told him that when he had independent research to justify his claims that he was more than welcomed to come back and discuss the product with me. Of course, ummm, he said he had stuff and he'd be back - he quickly left and I haven't seen him since. LOL
Drew, yeah, I was pretty sure reimbursement sucked.
Drew, your sentence that patients get an opportunistic window doesn't make sense to me...
So... if the symptoms return in 32-38 days... well, then how dramatic are the changes that you actually get? Do the balance deficits return with a vengence too? I'm really lost at the benefit of 6-12 visits to give a potentially desireable outcome in which the outcome only lasts 32-38 days...
AND... since there are "burn" warnings with use of that particular product, does it actually make any sense for a patient to use the thing at home? An already sensory deficit combined with a product that has a burn risk.... I don't think I'd personally put my license on the line and recommend something that has that kind of risk to be used independently in the home with the elderly population. Especially the current elderly population who aren't used to technology and from what I have seen can have a difficult time with their darn oxygen tanks with just using that thingy to turn it on or off....
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Re: Laser therapy - April 1, 2006 3:09:00 PM
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PTupdate.com
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Those that I personally know who use Anodyne have been very happy with the results...as have their patients. It does not work for everybody, and those who have success will need a home unit, as it has been shown the gains will slowly disappear. BUT, this treatment is often a last ditch effort for these people, and why not? The literature I have read may not be perfect, but it has less flaws than some of the studies the EBM guru's stand behind. Have some burns occurred? Sure, but who hasn't burned someone accidently with a hot pack, ES, or iontophoresis in their career?
The modality seems to work in conjunction with a program of exercise, balance and coordination, and I plan on getting one for my clinic as soon as I can get my butt moving. Another fairly good study is out there using H-wave therapy on neuropathy patients.
John Duffy, PT OCS
[URL=http://www.PTupdate.com]www.PTupdate.com[/URL]
_____________________________
John M. Duffy, PT
Board Certified Orthopaedic Clinical Specialist
www.PTupdate.com
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Re: Laser therapy - April 1, 2006 6:34:00 PM
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Andrew M. Ball PT PhD
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Patients with DPN are usually inactive --- this reduces both NO production as well as the efficiency at which it's used. Anodyne patients often report a decrease in pain, which allows for exercise (usually in a pool), which in turn helps the patient break the aforementioned cycle of pain --> lack of exercise --> lack of NO production and use --> pain. Without the pain, patients can sometimes begin (and maintain) a therex program that they would not otherwise be comfortable with. If they use the "opportunistic window" symptoms usually don't recur. If they don't, that's when symptoms return with a vengence. If they return, however, the need for a home unit is justified.
Also, you don't be serious about, "I'm really lost at the benefit of 6-12 visits to give a potentially desireable outcome in which the outcome only lasts 32-38 days.." Think about it SJ, that's a heck of a lot longer than dialysis works --- and like anodyne, it's a chronic condition that requires constant treatment --- but I don't think any of us would question the benefits of dialysis with respect to patient function!
As for the home unit, sure there is a risk of burns, but personally, I've only seen one once. It's like any other device, it must be used to specifications. Sure the company MAY have downplayed the burn risk, but it's not all that great to begin with. That said, it is up to the clinician to screen out which patients may be appropriate for a home unit and which may not. All patients with OA and knee pain are not THA candidates . . . why should Anodyne be any different? It's a God-sent for the right patients --- but can be like giving a gun to a baby for others.
As physical therapy moves toward autonomous interdependece, these are the kinds of calls we're going to make. If (D)PT's aren't prepared to make them, we should get out of the DPT game and forgo direct-access efforts right now.
Drew
_____________________________
Dr. Andrew M. Ball, PT, DPT, Ph.D.
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Re: Laser therapy - April 1, 2006 6:36:00 PM
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Andrew M. Ball PT PhD
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From: Charlotte, NC
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John,
I'd like to see that H-wave study if you've a copy. The problem with H-wave testing in patients with DPN is that the sensory nerves that we're trying to examine are usually too small and inexcitable to be measured by nerve conduction study.
Drew
_____________________________
Dr. Andrew M. Ball, PT, DPT, Ph.D.
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Re: Laser therapy - April 1, 2006 6:51:00 PM
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tucker
Posts: 182
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From: Texas
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LOL SJ. We're on the same wavelength!
John, you seem to downplay the risk of burns. We're talking about a group of patients that are already compromised for wound healing..not your average patient with low back pain. FDA reports 28, there were 2 in Clifft's study, and I have seen 3 in our hospital caused by outpatient or HH PTs. I also recall from a Healthcare Law class that burns were the number one lawsuit filed against PTs. Weigh that against the QUESTIONABLE benefit of improved temporary sensation...Risk outweighs benefit in my book.
Also, no disrespect, but responses such as 'literature may not be perfect' and 'if it helps the patient why not' are exactly what the manufacturers (or gurus) love to hear because they know they have at least a few years of PROFIT before independent researchers cannot replicate the studies and the claims are not true. But who cares...by that time the company has made a ton of money and are out the door. One example that comes to mind is topical hyperbaric oxygen units used in the late 80s for wound healing.
Point is...when it comes to a questionable product or concept (Ex. Craniosacral Therapy), we should demand some hard evidence before forking over the cash...otherwise it just encourages more scams in the future.
Darin Trees, PT, DPT, CWS
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Re: Laser therapy - April 1, 2006 11:07:00 PM
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Randy Dixon
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I agree with Darin, but...in the outpatient clinic there was a patient who really wanted to try out Anodyne and had the money burning a hole in her pocket so she purchased one for the clinic. Since it was there, it was used and now it is very popular with both patients and therapists, as they are seeing improvement, especially in edema, in cases where they weren't seeing improvement before. There have been no burns, I believe it is safer than a TENS unit, ice or a hot pack for patient home use so while it is an issue, it isn't one that I see as overly worrisome.
This leads to a small dilemna, it is easy to justify it's use, there is no charge for it most times, and it seems effective but what will we do if the studies find it is ineffective, we have to decide if we have all tricked ourselves or not.
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Re: Laser therapy - April 2, 2006 3:09:00 AM
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SJBird55
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LOL Drew
The benefits of dialysis are WAY different than the benefits of anodyne. And, to my knowledge, one stops dialysis if one decides to terminate life. You are arguing apples with oranges.
You didn't answer what happened after 32-38 days - pain probably increases, sensation probably decreases... and functionally?
Darin brings up a good point... good results are supposedly achieved.... but, that study seemed to indicate both the sham and the anodyne provided improved sensation, right? So... is this just another tool that with increased expectations, with lots of hope and some technology that that patient will improve? Short term results are NOT good enough with this population. Drew, for you to say that in 32-38 weeks a return of symptoms with a vengence is completely unacceptable. If the unit is so great and if a unit has a risk of burns with a population that we for sure never want to have a burn... ummm, I would think that as PTs we should skip having to decide who should have a home unit or maybe we should come up with a valid and reliable way to screen whether a patient would be safe with the unit (DPT or no DPT, there isn't any evidence that anyone would choose a home unit patient appropriately)... but maybe the appropriate fight would be that because of the risk factors with the tool with this specific population that maybe a fight should be made so that the population receives the appropriate care from the appropriate professional. One burn or 3 burns, for this population ANY burn is going to cost LOTS of money secondary to lack of healing factors and you better believe that the location of that burn will definitely be in an area that has vascular compromise because that's the area that is being targeted... Drew, the issue isn't a DPT issue.. it is a physical therapist issue.
Personally, the way that I see these devices. The cold hard truth is that there isn't a lot of convincing evidence out there. But many of us in our own little ways, want to stay on top in the rat race. How better of a way to do that than to offer "something" that isn't mainstream yet? It gains referrals just by having the thing via making contacts with referrals and the public. Yep, there's a reimbursement loss, but it gets the word out, patients come through the doors with hope... the PT does more than just the new tool to justify him/herself so profit occurs. Darin, the profit isn't just for the manufacturing company - we as professionals get roped into it too and if the manufacturing company does a good job of convincing us the value of their product and we go along and use it, then they generate profits too. AND, we all know that patients are loyal - they'll be back along with their family, neighbors, relatives IF the need for services arises again. For a patient to be right back in the same old boat in 32-38 days just isn't what physical therapy is about... at least not to me, but hey, I'm not a DPT. LOL
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