TENS stimulation for WED/RLS: Effective parameters

Please share your experiences, successes, and failures in using non-drug therapies for RLS/WED (methods of relief that don't involve swallowing or injecting anything), including compression, heat, light, stretches, acupuncture, etc. Also under this heading, medical interventions that don't involve the administration of a medicine to the body (eg. varicose-vein operations, deep-brain stimulation). [This forum contains Topics started prior to 2009 that deal with Non-prescription Medicines, Supplements, & Diet.]
badnights
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Re: TENS stimulation for WED/RLS: Effective parameters

Postby badnights » Tue Sep 22, 2015 4:05 am

It could be that the FDA only seeks proof that a product is effective and safe in order to approve it, and does not consider whether similar results can be obtained with generally available products that are much less expensive.
I would think so. The FDA has no mandate to consider cost, as far as I know, only safety and efficacy.
Beth - Wishing you all restful sleep tonight
WED/RLS AUGMENTATION:
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Norm
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Re: TENS stimulation for WED/RLS: Effective parameters

Postby Norm » Thu Sep 24, 2015 11:49 am

badnights wrote:
How did you access this unpublished statistical information? Are you affiliated with CP Wand manufacturers in some way? It would be nice if these results were published so others can learn from and build on them. The main reason people choose not to publish in my experience is when their results do not actually support their claims.


Hi Badnights,

The statistical information I referred to is not any sort of claim. It is only what I have seen from a distributor who has no intent to further science but every intent to help their patients. The reason I mentioned this is because the demonstration from this distributor is free. So no one has anything to lose and everything to gain. That is a lot better than most products where you have to buy something before you find out if it works. There is no current effort as far as I know by the manufacturer, to do scientific studies aimed at making specific formal claims on the device in question. Their product is sold after a free demo to prove the efficacy for a particular patient. Far too many claims are made on products that are not effective for certain patients and that is one of the reasons for such skepticism on new medical devices. Each patient is different.

Also, may I suggest that the main reason manufacturers choose not to publish studies is the high cost. It is easy to spend $250K on a study and find that the results are negative. The best approach is for individual doctors who have no connection with the company to publish a totally independent paper showing their own experience with their patients. These doctors spend their time for the benefit of their patients, furthering science, and helping others. That is also the same reason most of us "non professionals" are here.

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Re: TENS stimulation for WED/RLS: Effective parameters

Postby Norm » Thu Sep 24, 2015 12:25 pm

prpl luv wrote

"The statistical info cited by Norm was based on a “study” conducted by the makers of the CP Relief Wand, and not published in peer reviewed professional journals. I’m very skeptical about this info, since it is not based on studies conducted by independent parties with no vested interest in the outcome."

I referenced "statistical information that I have seen". There was no intent to suggest it was a "study". You presumed that. Distributors keep detail records under their operating protocols. I am not allowed by law to see anything other than "statistics" if the distributor is willing to show them at all. This distributor sells the product only if the device is demonstrated to be effective for each patient. After a successful demonstration, the patient decides if they want to buy the unit. In my opinion, this is how all medical devices should be sold and there would be no unhappy patients out there like there are now. If a medical device reduces pain from 10 to 2 in minutes for a particular patient, cost is not really a factor. This distributor works out payment plans for tight budgets. In a perfect world, everything may be free but if that were the case, in my opinion most would not do anything except have fun. Also, throwing a few trinkets together to get the same results would be great if it works but as I understand it, this is a patented device, and there is a legal question to that.

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Re: TENS stimulation for WED/RLS: Effective parameters

Postby badnights » Tue Sep 29, 2015 9:22 am

The reason blind and double blind studies are done is because patients and experimenters alike can have biases - whether they realize it or not - that affect their evaluation of a treatment. The effect of subconscious bias can be substantial. One might feel that a treatment has worked simply because one wants it to work so badly. The effect of bias is well established, and the blind protocols were developed to eliminate it as much as possible.

A demo is not evidence to a scientist, who sees only that a patient believes he has been helped by a device he was told would help him. There being absolutely no control for the placebo effect, the evidence doesn't have the weight it would have if, for example, the patient had alternately received the real treatment and a non-treatment, not knowing which was which, and consistently picked the real treatment as benefiting him.

Data from a single patient is not convincing evidence. Such case studies are interesting, but to draw conclusions about the efficacy of a product, data from thousands of patients is typically needed. (That's why the studies cost so much.)

the demonstration from this distributor is free. So no one has anything to lose and everything to gain.
ummm ... they're a distributor of the product. They will gain a sale by convincing the patient it works, so the patient consequently will lose the cost of the product if he's erroneously convinced that it works.

It is easy to spend $250K on a study and find that the results are negative.
In an ideal world, all these negative results would be published. Negative results are valid and significant; they mean the product doesn't work. Unfortunately, a company with a financial stake in the product has a big incentive to keep negative results out of the public's view.
Beth - Wishing you all restful sleep tonight
WED/RLS AUGMENTATION:
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Discussion Board Moderator's posts don't reflect the RLS Foundation's opinion & are not medical advice

Norm
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Re: TENS stimulation for WED/RLS: Effective parameters

Postby Norm » Fri Oct 02, 2015 10:21 am

Hi Badnights,

Re: Double Blind Studies

I agree with everything you said. Thanks for clarifying any misunderstanding.

The misunderstanding was that I spoke of "Statistics" from a DME Distributor. DME distributors are licensed in almost all states. All are monitored closely by Medicare and insurance industry accreditation services. Each DME distributor has a licensed medical practitioner on staff and normally each medical technician would be a licensed nurse and/or have specialized medical training. They are required by insurance carriers to use specified medical protocols for each category of product they sell. They can be an extension of a practitioners staff when the practitioner does not sell prescription medical devices. They also provide in home followup as required by insurance or medical protocol.

The statistical information they obtain can be useful for insurance carriers to determine effectiveness of insurance coverage and/or to evaluate a distributor. A practitioner may also be able to access this statistical information to evaluate the distributor or make some particular judgement regarding their patient(s). Importantly, this is privately held information and is not published. Individual patient names and any such personal information is strictly confidential as prescribed under hipaa laws. It is what it is and does not compare to a scientific study.

I might only add that there are numerous scientific studies on TENS units. TENS units have a history of hit and miss with patients since a slight movement of the electrode can alter the direction of the electric current due to the varying resistivity of veins, muscle tissue, and other tissue within the body. In addition to this, each patient has unique vein locations which have relatively low impedance and are a prime conductor for electrical current. The veins (or arteries) can easily be the major determining factor of the flow of the bulk of the TENS current within the body. TENS nerve stimulation is generally effective in proportion to the amount of electrical current actually reaching the pain center. (Additional long term brain chemistry effects from therapy not being considered.)

Sorry for any misunderstanding.

Norm
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Re: TENS stimulation for WED/RLS: Effective parameters

Postby Norm » Sat Oct 03, 2015 11:53 am

badnights wrote:
"the demonstration from this distributor is free. So no one has anything to lose and everything to gain." ummm ... they're a distributor of the product. They will gain a sale by convincing the patient it works, so the patient consequently will lose the cost of the product if he's erroneously convinced that it works.


Is there a better way to do it? DME distributor protocol requires that the patient be checked in 30 days to verify that the patient has continued satisfactory relief. The DME distributors that I know, all make a refund if the patient is not satisfied after 30 days.

I guess there must be a lot of animosity out there regarding buying products that don't work. I would say that one should buy only reliable products from reliable medical suppliers.

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Re: TENS stimulation for WED/RLS: Effective parameters

Postby Polar Bear » Sat Oct 03, 2015 3:39 pm

I guess there must be a lot of animosity out there regarding buying products that don't work.


Many of us have been down the road of trying all sorts, reading what others have tried, and of course ploughing through the reviews of difference products and 'cures.'
If some product/vitamin etc. costs little then there's nothing to be lost by trying it out.
A piece of equipment may be prohibitive by its cost, even if a money back refund is offered.

However, whatever works for someone..... keep at it. We are all so different in our RLS and it's wonderful to see another sufferer find some relief.
Betty
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ViewsAskew
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Re: TENS stimulation for WED/RLS: Effective parameters

Postby ViewsAskew » Sat Oct 03, 2015 5:54 pm

Polar Bear wrote:
I guess there must be a lot of animosity out there regarding buying products that don't work.


Many of us have been down the road of trying all sorts, reading what others have tried, and of course ploughing through the reviews of difference products and 'cures.'
If some product/vitamin etc. costs little then there's nothing to be lost by trying it out.
A piece of equipment may be prohibitive by its cost, even if a money back refund is offered.

However, whatever works for someone..... keep at it. We are all so different in our RLS and it's wonderful to see another sufferer find some relief.


To add to your list....

Part of it for me is the dashed hope cycle.

Part of it is that some people deliberately take advantage of others.

Part of it is that you don't want anyone duped and the science behind many things is nonexistent. Even if tenuous or possible, it's not proven.

Part of it is that many people are not familiar with the scientific method and don't know that just because there is correlation doesn't mean there is causation.

Part of it is that researchers have been caught lying many times in the past. Many things trump honestly and ethical behavior.

And so on. It makes a person very leery.
Ann - Take what you need, leave the rest

Managing Your RLS

Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation, and are not medical advice.

Norm
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Re: TENS stimulation for WED/RLS: Effective parameters

Postby Norm » Mon Oct 05, 2015 1:41 pm

ViewsAskew,

Without doubt, I have been down that road myself. All the ads for products that don’t work...Grrr. Even the best scientific studies leave plenty of room for doubt for the individual patient. Nothing works for everyone.

RLS remains a hideous disease. As it progresses over the years, it sucks the life right out of a person. When sleep becomes impossible, life can almost become unbearable. Far too often, drugs that have serious consequences can bring the only relief, and that is a real shame. The same can often be said of serious pain.

I believe that anyone with RLS should not give up. There are a lot of medical scientists working on RLS and there will continue to be new things out there that will bring help to many.

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Re: TENS stimulation for WED/RLS: Effective parameters

Postby badnights » Tue Oct 06, 2015 12:25 am

Do you have RLS/WED, Norm?
Beth - Wishing you all restful sleep tonight
WED/RLS AUGMENTATION:
viewtopic.php?f=5&t=6532&p=61601#p61601
Discussion Board Moderator's posts don't reflect the RLS Foundation's opinion & are not medical advice

Norm
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Re: TENS stimulation for WED/RLS: Effective parameters

Postby Norm » Tue Oct 06, 2015 10:21 am

Yes I do, Badnights. I have severe RLS/WED below the knees. My left leg is much worse than my right leg.

pinkynose
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Re: TENS stimulation for WED/RLS: Effective parameters

Postby pinkynose » Sun Oct 11, 2015 2:06 pm

I bought my tens machine-7000 through Amazon for $25.00. It has helped me with muscle cramps and twitching. My usual placement is my low back and I use the 2 other pads on one calf, then the other. I can not tell which is positive and which is negative as there are no markings.

I also bought the separate sock that can be attached to the tens machine. It works but I find it to be stronger. The intensity can be lowered and there are several modes you can choose from but it is still harder for me to use because it almost hurts. I was woken last night because of twitching. I used it for 20 minutes and the twitching was gone and did not come back. For me that sure beats walking all over the house for an hour or longer.

My other issue is my skin in certain spots gets irritated. The irritation goes away eventually.
* Just a reminder my twitching may be RLS or may be due to Neuropathy. I have no dx

ViewsAskew
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Re: TENS stimulation for WED/RLS: Effective parameters

Postby ViewsAskew » Sun Oct 11, 2015 3:57 pm

That's great that it's working!
Ann - Take what you need, leave the rest



Managing Your RLS



Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation, and are not medical advice.

prpl luv
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Re: TENS stimulation for WED/RLS: Effective parameters

Postby prpl luv » Sun Oct 11, 2015 7:21 pm

Hi pinkynose. The wire with the red part just before the metal part that inserts into electrode is positive; the black is negative.
I would greatly appreciate if you would post what settings (mode, pulse width, rate) you use on the TENS-7000. (I know that it’s “different strokes for different folks”, but it may be helpful to know what works for another person.)
I'm also considering getting a “conductive garment”—such as the sock that you mention. There are many of these socks and arm/leg “sleeves” on the internet, but it’s difficult if not impossible to figure out which ones work well. (The dimensions - stretched and unstretched - of these garments are also not generally given.) I would like to know the model and manufacturer of the sock that you bought, and where you bought it from. Thanks very much.
Gayle. Searching for non-drug ways to treat my RLS

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Re: TENS stimulation for WED/RLS: Effective parameters

Postby peanut1 » Mon Oct 19, 2015 7:04 pm

I tried TENS too and it didn't do a damn thing for the RLS. Maybe it can work for people with muscle cramps and/or mild RLS, but I don't see how it can help people with severe RLS.


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