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Messages - dti

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1
Treatment Questions / Re: Partial Tear of Long Head Bicep Tendon
« on: February 26, 2018, 04:24:04 PM »
Hi westripling,

I'm sorry this post was missed by our moderators.  How is your bicep doing?  Funny that I tripped across it today because I have some underlying injury, i think, in my left bicep too recently.  Like everyone, i'm hoping it will pass in a few days but when I'm doing curls, something just doesn't feel right.

Are you still wanting to discuss your situation?  I'll watch this thread or if you prefer you can call our Treatment Advisors who know a lot about treating injuries with our products.

I hope you're all better already,

Scott

2
Customer Feedback / Re: Post Operative Partial Knee Replacement
« on: February 26, 2018, 04:15:24 PM »
Hi Jeff,

How goes the knee?  Are you still lifting?  I hope you're keeping well!

Scott

3
LOL, that's awesome Andy!  You are not crazy, some of the units do 'sing' a bit when they operate.  The shoulder one in particular get's noticed the most because it's so close to people's ears.  I'd say most people don't even notice.  Your highly tuned ear pays attention!

Yes, the device is much more sophisticated than just being on or off.  The BFST actively modulates the treatment to get the best results.  We don't really discuss the underlying operation too much because how works really isn't as important as what it does so we try to focus on the results rather than the method. 

I'm an electrical engineer who participated in the design and it's interesting to hear your sound engineer interpretation of what we are trying to achieve.  I like it!  From what you've described your device is functioning perfectly.  There are definitely modes where the sound is more or less noticeable and sometimes you can't hear it at all but it is still working.  And you are also correct that the audible sounds will not be the same 'song' for the 3 different settings.  Each setting is optimized for best results.  As you can tell, a 20 minute treatment goes through a fairly complex routine.  Over the years we've made many changes, constantly trying to improve the performance of the device.  Today's 'song' is the result of many years of R&D and it's the best tune we know for your shoulder today.

In terms of the feeling you get on the 3 settings, more is not necessarily better.  People often want to jump to level 3 when they get it thinking more is better.  But if the higher setting causes too much blood flow at the surface of your skin then that pooling blood actually forms a barrier to the energy getting to the underlying tissue.  We always recommend people use it on the lowest setting and only move up when they don't feel the warmth during treatment anymore and when after a 20 minute treatment their skin is not noticeably flushed.  As your body's blood flow improves in the treatment area, these things will diminish and you can move up another level.  Only people who use our products for a year or more and are relatively healthy are likely to use it on lvl 3.  When you jump to level 3 you're pumping up the volume but your body is responding by putting cottonballs in your ears (sending blood to the surface).

Your senses are not deceiving you, Andy.  It sounds like your Shoulder wrap is working properly and so is your body's response!

I hope you get better soon :)

Scott



4
Hi John,

Thanks for your question.  I happened to have had a rotator cuff injury myself so I'm very familiar with what you're going through.  That was before KB products were available and mine - partly because I didn't care for it well enough - took years to heal.

If it isn't hurting when at rest, then I'd say you're okay to go straight to BFST treatments.  Like Jesse, said, if you have pain continuously/regularly then you probably need to address that first with the ColdCure product.

When you feel that pain during certain motions, those are little setbacks and big messages that the injury isn't fully healed.  In fact, even after the pain is gone, your body is still recovering from the injury and replacing collagen tissue with proper muscle and tendon tissue for a year or more.  Using BFST for an extended period of time will help with this process and reduce your likelihood of reinjury long after the pain is gone.

I'd say go ahead with the BFST.  Remember the most important treatment is first thing in the morning when you get up and the second one is at the end of the day (provided you haven't had a serious setback during the day).  One or two more during the day is a great help too.  Th shoulder product has an optional battery pack available if you're on the go and want it to travel with you.  The battery isn't required, but some people like to get one too.

Thanks again for your question.  If you want to discuss your injury and treatment further, our Treatment Advisors are at the end of the phone 7 days a week.

Heal Quickly!

Scott

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Questions & Answers About Our Products / Re: Electromagnetic radiation
« on: April 08, 2017, 08:36:59 PM »
Hi Jay,

I think many people get confused by the word 'levels' which can refer to two very different things.

In terms of frequency, level would mean high frequency versus low frequency (frequency is also sometimes referred to by its companion term 'wavelength').  But level can also refer to the power level at any given wavelength.  For example you can have 1 watt of power at a wavelength of 1 nanometer or you can have 1 watt of power at a wavelength of 1 micrometer or you can have 1000 watts of power at either wavelength. 

There are dangerous wavelengths and safe wavelengths, and they are classified as ionizing and non-ionizing respectively.  Yes, even at very low levels, ionizing EMR is dangerous.  Non-ionizing EMR is generally safe until you get to very high powers.  For example placing  a 1 pound weight on your body won't harm you, neither will a 10 pound weight.  Lifting moderate weight is actually good for you.  But placing a 10,000 pound weight on your body will injure you.  Until you get to stupid power levels, non-ionizing energy is not harmful at all.  Ionizing energy is risky at all power levels.

That's why we really avoid getting into the science on the site.  It's very confusing and knowing the engineering behind it doesn't make it more or less effective.  As CS posted, the key thing is that the technology is safe and they are medically registered medical devices that have undergone incredible development to be both effective and safe.  You simply aren't going to find a safer option than BFST.

6
General Discussion / Re: tfcc partial tear right wrist
« on: February 03, 2017, 05:37:54 PM »
Is it possible to send a picture of the 'plastic' piece to our CS group?  That may help us identify the problem part and recommend a solution.

7
This is a very good example that even when the pain and swelling are gone, the underlying issue is usually far from healed.

It appears that the stimulation provided by the BFST was more than the injury was ready for.  It is not uncommon for people to make the mistake thinking that "if some is good, more is better".  This thought process causes people to start their treatments on level 3 from day 1.  It is very important to start your BFST treatments at level 1 and only move to the next level after a period of several treatments where the warmth of the treatment becomes much less noticeable.  Very few people ever move past level 2 even after a year of use.  The instructions indicate that even on level 1, if the area gets quite warm then to stop and just do shortened (5 - 10 minute) treatments for the first little while.  Over treatment can result in aggravated symptoms of pain and swelling.

There is nothing wrong with just doing a 5 minute treatment on level 1 the first time you use a BFST.  If your body is good with it, you can increase the treatment time and power level gradually over subsequent treatments.  When you are well on your way to being healed, you will be able to give yourself 20 minute treatments at level 2 without issue.  Even at that point you may not be fully healed, but you will definitely be well on the road.

If your symptoms get worse following BFST, this does mean you need to let up on treatments though.  You have to give your body time to heal as well.  This particular user had an injury that only stopped hurting after 3 months.  That generally indicates full healing will take over 1 year!  In the case of severe injury this can be the case.  BFST is designed to help and accelerate the healing process.  With serious injury, even with BFST, the process can still take some time.  Ultimately though, the most serious injuries can still heal with the proper care.

Respect the pain - it is there to guide you.  Be vigilant.  Be patient.  You can get better.

8
Questions & Answers About Our Products / Re: fda registered products
« on: February 03, 2017, 05:27:15 AM »
Hi Esteban,

Thank you for your questions.  There is a lot to cover in such a simple remark!

People generally have very little understanding about the FDA's (and the regulatory bodies of other countries) role in ensuring people get safe and effective medical treatment.  The FDA is a very large organization and you can be certain that they truly are ensuring that medical devices and drugs are both safe and effective.

In the way you have presented it, I believe you have been looking at equivalence in terms of device code.  Yes, the FDA groups devices into categories based on similar characteristics that devices might have.  That does not mean though that all devices assigned a given code are identical.  That is far from correct.  Consider, for example, IV bags.  There are big ones and small ones, some made from different materials based on what they might contain, they must protect and preserve and not adversely affect the contents they hold, some can be frozen, some not, still they are grouped under common codes.  This coding system is just the most superficial level of classification.  Generally, it does group products with similar characteristics because it allows some general rules to be applied to the group that make sense - mostly regarding safety.  Two devices sharing a common device code does not mean that the products are the same.  The device code does though mean that there is a certain minimum set of criteria that every device of that code must meet but in no way does it mean the devices are universally interchangeable.  The regulators have to start somewhere and this is the beginning.

"FDA registration is no guarantee of efficacy" - this can be very true or very false.  Sadly, the general public has been misled by too many companies selling "snake oil" / sham products that it has undermined the credibility of what the FDA stands for.  Companies making homeopathic remedies that are consumed need only need to demonstrate that they are safe for consumption as a food to get labeled FDA Registered as a food.  Nefariously, they then go out and tout medical benefits only to end their ad with a disclaimer that the product "does not heal, treat, or prevent any disease".  This undermines the integrity of the FDA so much it is truly a disservice to the public.  People don't realize that when you get to real pharmaceuticals and medical devices, that same organization (FDA) goes to great extents to ensure the well-being of the public is protected.  Depending on the Class of a medical device (Class I, II, III, or IV) different levels of vetting are performed.

Safety is always the overriding priority for FDA.  First and foremost, an FDA registered device must be as safe as possible and the company must demonstrate that ongoing monitoring and improvement of safety related items are given proper attention.  People don't realize that many braces and supports and cold packs (including most sold in pharmacies) are not FDA registered medical devices but are really sold as athletic apparel.  FDA registered medical devices of this sort are typically of the lowest class (Class I) but that still means there are safety concerns that must be addressed that the athletic devices do not, and it also means that the device and the manufacturer are subject to FDA scrutiny.

Consider the fabric.  There are standards of safety that must be met for materials that are used in the manufacture of baby clothes – these are the toughest apparel standards and there is a whole list of known dangerous substances that the material cannot contain because babies are known to suck on their clothes.  There is another standard for adult undergarments that is slightly less restrictive but still tight because they are in constant contact with your body.  There is another standard that is less restrictive yet for pants and shirts because they are not in contact with your body as much as under garments.  There is yet a lesser standard for coats and apparel that are really isolated by other layers of clothing, and then there is sports equipment that is unregulated.  You would be shocked at how many braces are classified as sporting equipment (ie no regulation on the materials used even though people fasten them right to their skin).  Even scarier is athletic tape which people adhere to their skin and wear for hours while they sweat.  As soon as you get to an FDA registered medical device, there is instantly a legal obligation for the company to make the device safe for the application even at the minimum level.

At King Brand we don’t just meet the minimum level of material safety.  For our products it would be reasonable to submit to the FDA that material suitable for undergarments is suitable for our products.  We’re safer than that.  We’re safer than baby clothes too.  King Brand uses material rated ISO 10993.  This means that the material isn’t just free of known dangerous substances, but that the material has gone through extensive testing on living tissue to guarantee that it has no toxic or other adverse impact on tissue health.  There’s a big difference between just avoiding certain chemicals and actually testing and proving that the material is safe.  To be clear, baby rated material does not mean that it has passed ISO 10993, it means it just doesn’t contain the chemicals on the current ban list.

We are not required to use ISO-10993 materials in our products – that’s way beyond the requirements of our device classification – but we do use them because we have that commitment to the quality of our products and the well-being of our customers.
Our BFST devices are Class II medical devices that share a category with heating pads that are used as medical devices.  Do we like being in that group? No, but unless we go through an arduous process and millions of dollars to have FDA set aside our own device category, it’s the best category for the starting point of FDA minimum standards for safety.  In terms of beneficial use, we consider our device more akin to diathermic Ultrasound and Shortwave Diathermy, each of which have their own codes but we are sufficiently unique from those technologies that we don’t belong there.  Eventually we will have the resources to pursue a unique code for our technology, but the big motivation for that is really to get unique HCPCS codes so that insurers will pay higher reimbursement values for our products (they go by the medical device codes too).  Where efficacy and safety of our products are concerned, that really is the function of the FDA.

Let’s discuss our claims.  You wrote, “To simply claim that the BFST wraps are superior to other products that might be therapeutic is not sufficient, in my view”.  FDA does not share your view.  In fact, the claims that any medical device manufacturer makes are very much a concern of FDA (and Health Canada and other countries’ health regulators).  The claims of other products that share a device class don’t matter at all.  The claims the manufacturer makes about what their product does matters a whole lot.  You can be certain that FDA looks very closely at the claims and then looks to see if you have evidence to back up your claims.  The more significant the claims, the more closely they scrutinize how diligently the company has done their research.  Now, to be clear, FDA does not review the data itself nor do they try to make conclusions from the research materials.  What they do is examine whether due diligence has been done that it is reasonable for the company to make such claims.  Don’t interpret this as the FDA doesn’t care.  The FDA cares, but they simply don’t have the resources to review the data and make their own conclusions about every study for every device. Think about it, they’d need a specialist about every technology and they'd spend tons of time on every device!  This is part of the reason you will see statements disclaiming FDA’s responsibility for the claims. 

FDA isn’t responsible for the claims, but you can be sure that they hold the manufacturer entirely responsible for the claims being made.  To protect the public, they review that due diligence was done without actually pouring through the material.  Then, on an ongoing basis, they enforce practices and policies that would expose any failure of a device to meet those claims.  FDA strictly requires that companies record any alleged deficiency of a product or a products performance no matter how minor.  When they come to inspect a facility (usually a very in-depth process of a week or longer) they go through and take back with them all the records of these complaints and very closely scrutinize what the company did about each one.  If they saw evidence of failure to meet the claims they would be all over it.  When it involves medical devices – what a company claims their device does is paramount.  Your device has to fulfill the claims.  Every device in the same device category does not make the same claims.  What is claimed by a specific device is what is important – not the device code.

You are not the first person to express a desire that we expose more information about our technology.  One reason is because we have no desire to tell other companies how to make our products.  We’ve spent hundreds of thousands of dollars on R&D and we have no intention to give it away.  Has FDA seen this information?  Absolutely.  The other reason is because it prevents other companies from producing sham products claiming they are the same because they have a common property.  If we say this device uses 1 watt of power, someone else will say their product uses 2 watts of power ergo it must be better even though the power is doing something completely different.  If someone wants to compete with us, they can do so based on what the products claim.  And we can make our claims because our products do what they say they do.  It’s as simple as that.  FDA looks at our claims you can be sure of it.  So does Health Canada and so do our ISO regulators.

The proof is in the pudding, Esteban.  You’re welcome to give our products a try.  :)

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Treatment Questions / Re: Knee Treatment Requirement
« on: December 19, 2014, 10:41:19 AM »
Hi Sohail,

Well, you're doing pretty well then.  Your body is demonstrating resilience and to me it appears you're knee is going through the healing / reinjury cycle.

No pain is a great sign. But, just because the pain is gone doesn't mean you are even close to healed.  I'm not sure if you've looked at our Healing page (http://www.kingbrand.com/Healing-Home.php) but it nicely summarizes what is happening in your knee.  Even when the pain is gone, your meniscus will still be mending itself for probably 2 years given what it has been through.  And that is if you really minimize the reinjury component. 

Even though the pain is gone, I can't stress enough the value of taking the load off your knee and giving it more opportunity to heal.  Cutting back on activity is most effective.  But if you're determined to stay active, I think a properly fitted brace that offloads your meniscus during activity is a good call in addition to your regular BFST treatments. 

Definitely keep up with the BFST for months, even if you don't feel pain again.  If you are going to be active, give yourself a treatment before you take up the activity to increase the blood flow in your knee.  This can go a long way towards preventing reinjury.  But BFST alone is not a guarantee - you still need to respect your injury.  Please go easy on your knee even if you don't feel pain.

When you do feel pain, you can be sure this is a signal that you re-tore your tissue again, if even slightly.  Every time you do feel pain, even if it is from something minor like a little twist, that is a backwards step in your healing process.

I agree with you on the Arthroscopic Surgery.  They'd just cut away some flaps of meniscus hanging off the ends and you'd have less meniscus to work with.  In the Healing page you will read about the stage of healing where your body grows tissue that shrinks and pulls the jagged edges of your tear back together.  If that part of the healing cycle is successful but you have cut back the fringes, what is there to protect the outer edges as the inside becomes stronger?  The Athro procedure is something you do if you accept that you are ultimately going to do the knee replacement and just want to buy some time.

As for the total knee replacement, it's one heck of a procedure but it sure does work well.  The artificial knees work exceptionally well and all your pain will be gone (because that part of your knee won't exist any more as living tissue).   I'm actually a fan of this route if the damage / degeneration becomes irreparable (a point it doesn't sound like you are at).  If you ever get to this point, select your Surgeon and parts carefully.  All components are not created equally and you can get premium parts that perform much better than others.

Good luck with the healing process and remember to give your knee a rest and respect the pain!


10
Treatment Questions / Re: Knee Treatment Requirement
« on: December 15, 2014, 04:40:28 PM »
Hi Sohail,

It appears your condition has been pretty rough for quite a while.  I commend you for not taking pain killers - you don't want to mask the severity of your injury.

The confusing part for me is that you indicate you are very careful about loading your knee but your conditions seems to persist and change as though there is healing and reinjury occurring. Can you elaborate on how active you are and to what extent you have isolated/protected your injury?

What has your doctor recommended?  I would expect you to have been using a rigid brace since your first diagnosis.  Have you done any extended time on crutches with a brace / cast to immobilize the injury for a while?

It doesn't sound incurable without surgical intervention, but your situation is far from great as you know and if you don't heal before too much longer surgery will be inevitable.

11
The customer product was eventually received and the purchase amount refunded.  This was a very exceptional case.  Most returns come back very promptly and it is our policy to process returns and issue the full credit immediately upon receipt.

You can see from the customer's initial post that we are very proactive about getting our product out to you quickly.  Our customers are injured and in pain and it is important to get the products that will help them out quickly.  All of our customers are important and behind the scenes we were actively pursuing the carrier to get the product back for this customer.  It is unfortunate that it took so long but that element was out of our control, just as it was out of the customer's control. 

12
Treatment Questions / Re: Meniscus injury Left Knee
« on: June 25, 2014, 05:12:39 PM »
Regarding the power, the power supply that comes with the unit works from 100VAC-240VAC, 50Hz-60Hz.  This means it will work with any power in any country.  The only thing is you might require an adapter for the pin configuration of the country you are in.  If you have any questions you can contact us.  We can supply pinout adapters for any country.

13
Treatment Questions / Re: Best way to treat Carpal Tunnel Syndrome?
« on: June 25, 2014, 05:07:42 PM »
Hi eightthirty,

How has your treatment been going?

14
Questions & Answers About Our Products / Re: this verses tens unit
« on: December 12, 2013, 01:48:13 AM »
Hi kcbtyler,

The two technologies are actually very different.  To be clear, TENS units actually deliver electricity into your body.  In essence TENS electrocutes the muscles and nerves over and over again until they are exhausted and unresponsive once the TENS stops.  There was a time when electrocuting parts of the body was considered good medicine.  That is a lot less common now as medicine has advanced a lot since the 1950's.

TENS is a very old and primitive treatment.  It remains part of many insurance coverages simply because it was added decades ago and its kind of a matter of 'once your in your in'.  It is rare that insurance companies drop these kinds of items from their coverage because, as Doctors and PTs quit using old less effective methods, it pretty much becomes a non-issue for them anyway.

BFST does not electrocute your body.  The energy delivered by BFST travels through air and skin like the warmth from the sun or a television signal.  As it passes through your soft tissue, it energizes your circulatory system causing blood flow to increase.  The energy from a BFST Energy Web is 'tuned' to stimulate soft tissue the most while being fairly transparent to the skin so it can get deep inside your body.

BFST is relatively new.  We have been developing it since 2007 and have been manufacturing and promoting it since late 2011.  It is well evolved and fully FDA approved and available to the public.  But it takes a long time before Insurance companies add new technology to their policies.  It's very common for new medicines to be on the market for 10 years or more before they are commonly covered by most insurance companies.  It doesn't just happen automatically either, we have to go through a ton of work to get added to the lists.  We're working on it, but truthfully, widespread insurance coverage will be 2 or more years out.

To answer your question comparing BFST to TENS, BFST is 60 years ahead in technology but 60 years behind in working with insurance companies.

I hope this helps :)



15
Questions & Answers About Our Products / Re: Any efficacy research?
« on: December 04, 2013, 03:27:49 PM »
Hi WJ,

Thank you for your question.  We sincerely appreciate your interest in our products.

You have asked a great question which is loaded with issues that we are trying to work through ourselves.  You identified one of the biggest issues in your post, probably without even realizing it.  What do you consider "standard rehabilitation protocols alone"?  Is that doing nothing at all?  Is it phyisio?  If so what kinds with what therapies?  And for what conditions?  And for what parts of the body?  And for what grade of injury?  The scope of conditions is overwhelming and it is difficult to publish meaningful data that reaches the breadth of audience.  It is also prohibitively expensive to do unique studies on each condition.

We are currently working on an application that will allow all users of our products and non-users to participate in submitting data just for the purpose you describe.  We will allow people to identify their ailment and the treatment they are using.  They can then provide regular updates on their progress and that data will become visible to everyone (no personal identification information will be collected or reported).  In time this will hopefully give us a broad set of data to reveal to everyone what works best for people in their condition.  Hopefully this will be out in a few months time.

You asked specifically about BFST.  BFST stands for Blood Flow Stimulation Therapy.  Fundamentally this technology runs on the premise that, in the indicated conditions that we recommend it, increasing blood flow is demonstrated by tons of independent research to improve healing.  If increased blood flow to the area won't help, BFST most likely won't help.  If increased blood flow is desirable, then BFST is an excellent choice.  It is important at this point to understand how we design BFST products.  We don't develop BFST products specifically for a single condition such as your MCL injury.  We design and constantly redesign BFST products to improve blood flow beneath the skin and that's it.  We are confident that if we can make the best possible device at improving sub-dermal circulation, the benefits will be realized in the areas that are applicable. 

We spend a lot of time and money constantly improving our products.  The BFST and ColdCure devices we sell today are better than the ones we sold two years ago.  By better, I mean the BFST Energy Web is better at stimulating blood flow in deep tissue and the ColdCure gel has more cold capacity and better thermal transfer characteristics.  The versions from 2 years ago were better than the ones from 4 years ago, and the ones next year will be better than last year.  Our technology is constantly getting better.  I can tell you for sure that if you want to stimulate your circulation, the BFST product we offer is the best product we can devise after many years of constant research and re-engineering.  And with great certainty I can tell you there is no other company or product that has anywhere near the level of expertise and experience we have in this arena.  Whether your particular MCL injury will recover faster with even more blood flow is a question your physician is better qualified to answer.

I respect your diligence in looking for studies.  There is a lot of mis-information online.  This is a big issue for us as well.  There are many companies selling products that do no good, and in some cases even make conditions worse.  I could give you a long list of products that are commonly used but are nothing more than placebos and, sadly, in too many cases can make a person's condition worse.  How many times have you seen something marketed with the trailer "the preceding product has not been evaluated by the FDA and is not intended to treat, cure, or heal any disease" or something to that effect.  Yet people buy them in droves anyway.  It's very distressing.  We are not one of those companies.  Our BFST product is an FDA registered medical device and that means a lot to you.

The FDA is here to protect you and look out for your best interests.  The FDA (and related ISO standards) rules that govern our product REQUIRE that proof of efficacy exists.  FDA rules REQUIRE that our products are safe.  FDA rules REQUIRE that we maintain very high standards of testing and manufacturing and materials quality.  FDA rules REQUIRE that everything that matters is documented and signed and traceable.  When the FDA came for their routine audit last spring they came and stayed for an entire week.  We were inspected very intensely and you can be sure that they made sure that we complied with ALL of the rules that are there to protect you.  They went through tons of records and documentation.  Before they even got here they had examined and printed out what looked like our entire website to understand the claims we are making.  The US government has checked us out for you to make sure we are legit.  We're not special, all manufacturers of FDA devices get inspected.  That's why so few companies are FDA registered, because you can only pass if you are a legitimate company manufacturing legitimate products to a very high standard.  FDA registration means a lot.  I would hope any time you use any product or medicine to help with a medical condition you always check to see if the treatment is FDA registered.  If it isn't (and it might surprise you how often this is the case) then it's probably a waste of your time and money.

WJ, I'm sorry I can't turn around a say, "yes, here's a study on BFST and grade I laterally torn MCL injuries".  I can only tell you that the BFST Knee Device will certainly stimulate blood flow in your MCL and surrounding tissue.  I don't know the specifics of your condition so I would be irresponsible to definitively prescribe your treatment.  If your physician feels that blood flow stimulation would be beneficial in your case, I strongly recommend this product.  In this case, you would not be going on untested claims alone, the FDA has been here on your behalf to look out for your best interests.

Thanks again for considering our product.





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