Report on non-surgical CTRAC treatment

DougCuk
Offline

I am a 54 year old male living in the Redbridge & Waltham Forest NHS region.
I had suffered transient tingling in my left hand, following specific activities, for several years - but this was avoidable.
I started to get persistent numbness and tingling in my left hand in December 2010 this got worse into January 2011.

I was diagnosed with bilateral carpal tunnel lesions following nerve conduction and EMG tests (31-Mar-2011).
I was sent a copy of the neuropysiology results and ran through the grading scheme you have on the website.
This appeared to resolve as a R/H Grade 3 - L/H Grade 4

I wanted to avoid surgery if at all possible - as I am a full time carer for my father who has dementia and mobility issues.
I therefore did some online research into non-surgical treatment options - and decided to give the CTRAC ligament stretching device a try. While waiting for the NHS cogs to split out a recommendation for CTS surgery I was able to purchase a CTRAC device, from the USA, have it delivered and complete 5 weeks of treatment on my left wrist.

I used the CTRAC device as directed - (2 minutes stretch - 1 minute recovery - 2 minute stretch) repeated 3 or 4 times/day for 4-6 weeks. After five days the constant background tingling was obviously reduced. After 10 days both the numbness and tingling were much improved - and the aching pains in my fingers and forearm had disappeared.

After 14 days I was experiencing near normal feeling in my left hand for an hour or so directly after each treatment - with mild symptoms returning prior to the next treatment. By day 26 the only remaining symptom was a very slight residual numbness in the treated hand - and this has gradually improved through to day 38 (5 weeks) when I took a break from treatment. I am currently at day 50 (7 weeks) after start of CTRAC treatment and am symptom free apart from a vague residual numbness in the tips of my thumb and fingers.

At 38 days I discussed with my GP the offer of surgery and decided to decline/postpone - pending the longer term results of my CTRAC treatment. I have now started preventative treatments on my right wrist, which was virtually symptom free. I intend to continue to use the CTRAC treatments as required and am hopeful that it will allow me to manage my condition. Comments and questions?

jeremydpbland
Online

The C-trac device is quite promising but is lacking in good quality trials to support it's effectiveness. I believe that there is now a UK distributor for it so you do not have to purchase directly from the USA. We have a half finished trial which was started in Canada and which we hope to complete in Canterbury but this is held up awaiting ethical committee approval at present. It would be nice to know whether your NCS results have improved in line with the symptoms - they usually do but in this unusual circumstance it would be useful to have any change documented  JB

DougCuk
Offline

Thanks for the reply - good to know there is ongoing interest in better trials.

Another UK trial (Reg No: ISRCTN26618585) was supposed to be in progress at the Pulvertaft Hand Centre - Derby Royal Infirmary, sponsored by the UK importer Heritage Medical - and due to complete this summer. However neither party have released any details - do you know if this trial actually got off the ground?

I would also be interested to know how my NCS results have changed - just not sure how easy it will be to get a follow-up test on the NHS. My symptoms are now in full remission - and I am continuing with a single treatment each day (which only takes 8 minutes for both hands) to maintain my current status.

The UK distributor will only supply to health professionals, so once I had a confirmed diagnosis it was simpler and quicker to order from the USA. Even with shipping and import duty it was still cheaper ordering from America. Even better value now, the price has just dropped again - now available at $150 plus shipping and taxes.

jeremydpbland
Online

Thanks for the follow-up. The Pulvertaft do a lot of work on CTS though I think it's fair to say they come at it from a much more surgical angle than I do. I wasn't aware they were trying a c-trac trial - they don't talk to me much :-) - thanks for the reference. They have gone for a 5 year follow-up which is pretty ambitious for 50 patients and I imagine that this a single blind trial as it will be pretty obvious to the patients which type of device they are getting. Hopefully we will see some results in 2012 though curiously there is no mention of this on the Pulvertaft Centre website that I can see.

MIKE1985
Offline

it's great to read your success story Doug

I'm 26/MALE and have tried everything to treat the diagnosed CTS in my right hand (surgery is booked but could be a lifetime away) the splints/exercises/nsaids/B6 - even a steroid injection only helped for 2-3 days

it's been just shy of 10 months now with the usual symptoms constantly but the last two months have been agony

i start my CTRAC treatment very soon and will be happy to report back here with hopefully good news

fingers crossed (left hand!)

jeremydpbland
Online

The pulvertaft hand centre trial should be appearing in print soon. I'll post the findings here once they are public. JB

Anne1
Offline

Hello Doug, I am new to this forum but have been diagnosed with Carpal Tunnel syndrone. I have been offered the steroid injection and if I had said yes the operation. However, both are a bit scary to me plus I look after my 2 1/2 year old grandson aswell as being self employed. I note with interest your story do you know of any risks in this contraption C Trac i.e anthing stated on leaflet /instructions that I assume would have come with it?

jeremydpbland
Online

I have come across no reports of ill effects (other than to the wallet!) and one would not really expect any if the thing is used as advised for fairly short periods. Whether it really is effective however awaits some better quality evidence.. Conventional splints have a known, though modest, effectiveness and are completely free of significant side effects so they should probably be tried before anything else. JB

Cecilia Abejo
Offline

I too, was diagnosed with bilateral carpal tunnel syndrome, i am a hands on mom right, we no maid to do the repetitive household chores , how I wish i could avail of this CTRAC treatment , what is this? how is this? I am from the Philippines, i am formerly a hard working teacher and a mother of two...i want to avail ..please do help me ..i want to know more of this treatment, i used to research CTS ,its treatment , at home and pain releiver, i do not like to undergo surgery as much as possible..hope to hear from you ,ASAP.

jeremydpbland
Online

I do not know if there is any local supplier in the Philippines but the American manufacturer is happy to ship the device abroad for a price. The downside of course is that the evidence that it actually works is not of very high quality and I could not endorse its use until some decent trial evidence of effectiveness is forthcoming. Two trials are in progress so we may have some better guidance in a little while. In the meantime paying a considerable amount for it may not be a good investment though it is probably fair to say that, used as advised, it is unlikely to do any harm other than to your wallet. If you do manage to get hold of one and try it out please let us know what sort of results you get as the more reports of this device we receive the more we will understand whether it is worth trying or not. JB

ChasN
Offline

Hello I am a 59 year old male recently tested (wired) at macclesfield for CTS and diagnosed for surgery on RHS in nov, but also have problems with LHS.
I am keen to try C Trac & have found it available at discount in Cardiff. I have also found Carpal Solution (disposable kinesiotape) from First Hand Medical, salt lake city-£46 for 6 week trial on one hand, has anyone tried this, it offers benefit that you sleep with tapes on & dont have to spend time exercising with the special support ? CN

jeremydpbland
Online

I have come across the 'Carpal Solution' advert but there seems to be no satisfactory evidence that it has any effect on CTS. Like the c-trac device however it seems unlikely to do any harm, other than to your wallet. Has any treatment other than surgery been tried/offered - I am curious about practice in managing CTS elsewhere in the country. JB

DougCuk
Offline

When I started this thread I had always intended to come back and post an update on my experiences using the CTRAC device - but life as a full time carer for my dad just got in the way.

It is now 20 months since I completed the original course of CTRAC treatment back in May 2011 - and my carpal tunnel syndrome is still being kept at bay - I continue to use the CTRAC treatment a few times a week as required. After the initial intensive 6 week course of treatment my symptoms went into full remission for around 4 months. When I noticed the first signs of a relapse I used the CTRAC device in a less intensive way to keep the symptoms under control.

If you have serious CTS symptoms you do need to use the CTRAC treatment at least 3 or 4 times per day for 4-6 weeks to obtain long term remission of symptoms. You also need to be very organised to keep the CTRAC device with you and carry out treatments throughout the day and keep track of all the treatment sessions - you really do need a log-book to keep track of it all. If you manage to stick to the routine my experience is that the device does give very obvious remission of symptoms and can then be used to manage any relapses. Obviously if you already have nerve damage due to long term or aggressive CTS then the CTRAC treatment may not be as successful,

I treated both wrists even though I was only getting active symptoms in my left wrist - the nerve conduction tests showed both wrists had problems. By swapping the CTRAC device from left to right and back again you can complete a sequence of treatment on both wrists in 8 minutes - each wrist gets 2 minutes of treatment followed by 2 minutes relaxed then 2 minutes of treatment - with no wasted time between treatments.

The CTRAC treatment is quite an aggressive process and you need to stick to the treatment times and inflation pressures for the first few weeks. However as your carpal tunnel begins to respond to the decompression it may be possible to increase the treatment times and the number of repeats in each session - this can speed up the decompression process. Be guided by any after effects of the treatment and reduce treatment intensity if you experience any tenderness in the wrist. Do not be tempted to increase the inflation pressure beyond 200 - you can however top up the pressure if it falls during a treatment session.

That's all for now - but I do have some more pointers on using the CTRAC that I will try and post sometime soon. I also have some feedback on using the Carpal Solution device mentioned in one of the previous posts.

jeremydpbland
Online

Thanks for the update. From that description I would take your experience as indicating a palliative rather than curative effect - it's a great deal of recurring use of the device over a long period so a significant degree of nuisance value as a treatment. One might wonder about what you mean by 'any after effects' of the treatment. Pulvertaft have still not managed to get their trial into print so far as I know. JB

DougCuk
Offline

I supposed that depends on your definition of palliative. CTRAC achieves relief of symptoms by stretching the ligament that is causing the nerve compression - and as long as you persist with treatments to maintain the ligament in its stretched state then the cure can be permanent.

While persisting with treatments can be a minor nuisance the benefits can be freedom from any symptoms. In my experience you seem to need a maximum of one treatment per day - taking 8 minutes of both wrists - which can be done while relaxing each evening. Even this may be overkill and I have certainly gone for many months with either no treatments or just a weekly topup treatment. I view it in the same way as doing stretching exercises for my bad back - either I do them regularly or I have a relapse and suffer the pain.

While in theory surgery could be a one time fix I think you would have to admit that this is not always the case - and I for one prefer to keep the ligament intact - and doing the job it was evolved for - if at all possible.

As mentioned above if you choose to increase the treatment times and/or the number of repetitions then you may experience tenderness or persisting soreness in the wrist. This is not beneficial and you should reduce the intensity of the treatment to avoid this "after effect" of the CTRAC treatment.

After a few weeks of treatment I was able to tolerate 3 minutes of stretching and several extra repeats on each session. Each person needs to assess their own comfortable limits. Performed correctly there should be no discomfort after each treatment and you should absolutely avoid causing any inflammation of the ligament or other structures of the wrist during treatments.

jeremydpbland
Online

I'm not at all sure I believe the manufacturers theory that this device stretches the ligament - there is actually no concrete evidence that this is the case and I think it is equally plausible that it is simply massaging fluid out of the carpal tunnel by applying sustained pressure. The transverse carpal ligament is an extremely tough structure - stronger than steel in tension. I do agree that avoidance of surgery is desirable though. Although it is generally successful I see far more people who are unhappy with the results of surgery than I would wish to, and you can see a few self reports in the forum here. JB

PhilL
Offline

I live in the US. What are the problems to which you are referring that people have faced following surgery ? I am scheduled for nerve conduction tests. If they support CTS, surgery has been recommended. The surgeon I'm seeing does endoscopic surgery. Do the issues you're referring to relate to specific surgical techniques? Over the past several months I used a night splint, had acupuncture, chiropractic treatment, and have used yoga stretches. I've obtained minimal relief. I discovered CTRAC in an article in Journal of Hand and am considering using it.

jeremydpbland
Online

You will find an extensive discussion of surgery, it's prognosis and outcome on this site - have a look under treatments - it makes no real difference whether you use the traditional 'open' operation or one of the endoscopic methods. Trying a night splint is a good idea as they are modestly successful but I'm not surprised at the lack of benefit from acupuncture, chiropractic and yoga as there is minimal good quality evidence to support the use of these interventions in CTS. The CTRAC device is interesting but it really needs a decent trial carrying out as so far the only evidence that it works is either anecdote or essentially published by the manufacturer. JB

PhilL
Offline

Are you familiar with J Hand Therapy 2007 Jan-Mar? Link to the abstract http://www.ncbi.nlm.nih.gov/pubmed/17254905
I have a PDF of the complete research paper. PL

jeremydpbland
Online

There is something amiss with that link but I presume you mean Porrata et al which is the paper I was referring to under the ligament stretching devices section of this page. It is rather a poor study which would be automatically rejected from any serious meta-analysis because of the lack of control subjects. A colleague of mine has a half finished trial of the C-trac which was started before he moved from Canada to the UK but we have been unable to get ethics and research governance approval to finish it off so far here. There was a trial of C-trac in progress at the Pulvertaft hand centre in Derbyshire but this seems not to have been published so far (if anyone knows where it has appeared please tell me) and I only have an informal communication of the results from the authors which I cannot share! JB

Edit - the Pulvertaft trial is now published - see below

mayerlene
Offline

I have just found this thread and, although I haven't yet been definitively diagnosed with CTS, DougCuk's experience, and my worsening symptoms, have left me wondering whether I should blow my savings on C-Trac! I'm sure JB will advise me to grit my teeth and be patient until I've been seen by someone.

jeremydpbland
Online

If it's a case of 'blowing your savings' then definitely wait - try a much cheaper conventional splint first. JB

ML
Offline

Hello all

I am new to this forum. I was diagnosed with CTS in December 2012 by a nerve conduction test. Since then my symptoms have been worsening and I now have constant tingling in my hand. Sometimes this can be hardly noticeable, other times it can be quite painful accompanied by shooting and burning pain in the thumb, index and middle finger of the affected hand. I have today had delivery of a c trac from the USA and have carried out the first two sessions of three that I have to do every day for the next six weeks.

I see other members have had some success with this device and I understand a trial was carried out in Derby but the results have yet to be published.

For anyone interested I will post my progress with this device in a few weeks.

jeremydpbland
Online

The Derby trial results should appear shortly but more patient reports on here are always welcome. They are probably most useful when someone commits to reporting the response before trying the device out and then does so after a few weeks. Reports from people who have already experienced some benefit are subject to severe reporting bias. I have fairly serious doubts about whether the C-trac works in the way it claims to (stretching the transverse carpal ligament) but there are other possible effects it might have and I'm keeping an open mind about it. Have you tried the much simpler and cheaper neutral angle wrist splint? JB

ML
Offline

Hello Jeremy

No I haven't. My GP told me I could buy a splint and wear this at night, but to be quite honest the symptoms have not disturbed me when sleeping as yet.

It would be impractical to wear one during the day as my job involves a lot of driving and it would probably be a little impractical

jeremydpbland
Online

They seem to work sometimes for controlling daytime symptoms even when worn only at night. I think the effect is related to giving the nerve/tunnel 8 hours of 'recovery time' while you are asleep without the additional stress imposed by most people's normal sleeping position. CTS starting with daytime symptoms alone is of course comparatively unusual and always makes me wonder if there is something intrinsically different about such patients but I haven't got around to doing any serious statistics on the issue yet. JB

ML
Offline

JB, I said in my earlier message that my symptoms didn't bother me at night. They don't wake me up, but when The alarm sounds and I wake up the symptoms sometimes are there, numbness in the thumb,index and middle finger. I read that some members know what grade of severity their CT symptoms are. I was not given this information when I was told the results of the nerve conduction test by my GP. Only that they had come back as positive for CT in my left hand, which incidentally is my leading hand. I would think that having read some of the threads from other members my symptoms are still relatively new and mild although they have worsened over past couple of months.

I have now completed nine sessions with the C trac and already feel some improvement. Early days I know and probably to early to tell. Will keep you posted.

jeremydpbland
Online

Not everyone grades CTS severity in the same way and if you only have tests done using one of the hand held simple testing machines which are marketed directly to GPs, orthopaedic surgeons and others then all you will get is normal/abnormal on the whole. The Italians are better than we are at this and at least 22 centres in Italy all use the same severity grading so that you can make some kind of comparison between different labs. When I am talking about severity grades these apply only to the degree of measured physiological abnormality and these grades are not closely related to the severity of symptoms experienced by the patient. JB

jeremydpbland
Online

The Pulvertaft Hand Centre trial of the C-Trac has just been published and I have amended the alternative treatments section of this site to give a short summary of the findings but it boils down to - no more effective than an ordinary splint but more expensive and perhaps with more side effects. JB

ML
Offline

Thanks JB. I have studied the results with curiosity. I am 10 days into my c trac treatment now. It does seem to be providing some relief of symptoms but is still to early to tell. I will report my findings in four weeks time.

mayerlene
Offline

I am writing to add to the general experience of CTRAC. I am a 66 year-old female, who developed bilateral CTS in January. Nerve conduction tests showed that both were of grade 4 severity. I was keen to avoid surgery and, impressed by the success that DougCuk had reported, ordered the machine. I tried it for 4 weeks, but, sadly, it made no difference to either of my hands and I had to opt for surgery. Luckily, I was given a nearly full refund for the machine. I certainly hope others find it more helpful.

ML
Offline

I have just completed the first six weeks of three times a day sessions with C trac. I have to say I am a little disappointed .

After using it for this period of time it does give some relief from symptoms providing I continue to use it every day. If I miss a day or two they return.

My advice to anyone considering buying one. Don't waste your money.

jeremydpbland
Online

Thanks for the update - this thread is beginning to provide a more useful overall impression of this device but we really need about 100 people to report their experiences with it I guess. We'll see how it progresses over time. JB

porratah
Offline

This is not advertisement
Dr Bland,

I had the oportunity of reading and reviewing the article published by Dr Storey and Dr Burke at The Pulvetaft Hand Center regarding C TRAC. I have to comment on the study.

The Pulvetaft Hand Center study commented, and I quote "The decision to continue with the splint (treatment success), or to proceed to invasive treatment (surgery) and therefore leave the trial (treatment failure), was at the discretion of the patients"

The data from the study Figure 1 showed that 72% of the BWB users failed and went to surgery vs just 42% of the C TRAC users. Meaning that 58% of the C TRAC users were able to avoid surgery vs just 28% of the BWB users. Those results are similar to the numbers of the manufacturer who states 69-75% are able to avoid Carpal Tunnel Syndrome Surgery.

There is obviously a financial bias by the manufacturer, could there be a financial bias by the surgeons (authors) since only 42% of C TRAC users proceed with surgery? vs the 72% that proceed with surgery when the BWB brace is used? that bias should be commented on in the article.

I also noted on table 2 that patients on C TRAC had a decrease in the symptom severity score by -0.7 out of 1-5 compared to a reduction of just -0.1 on the BWB brace. There was also a reduction on the Levine function score of -0.3 on C TRAC vs -0.1 on the BWB brace. On a Levine scale of 1-5, where many and probably most of the patients have a 3/5 score, a median (not mean, mean may be more or less) 0.7 decrease in symptom severity may be something patients would find important and worth trying.

In the conclusion Mr Storey states, and I quote:

"we have shown that it (C TRAC) is an alternative to the BWB for the non-operative management of idiopathic CTS in patients aged between 18 and 65 years".

I see the above comment in your post is a from the abstract, not the published article conclusion and I am trying to understand why the discrepancy between the abstract and the article. Also of note, Mr Storey expressed that his article may suffer of Type 2 statistical error, can you please elaborate on what that means?

Considering that many more patients opted to avoid surgery in the C TRAC group 58%, and that C TRAC offers a money back guarantee of 30 days where patients can try it, and the cost is $149 dollars, not pounds as expressed in this blog, I agree with the conclusion of the Pulvetaft Hand Center C TRAC study and also believe C TRAC is an option for those who do not want surgery for Carpal tunnel Syndrome.

Financial Disclosure:. I invented C TRAC and I have a financial interest.
This is not advertisement.

Humberto Porrata MD
Inventor C TRAC
Owner Carpal Doctors LLC
Board Certified Physical Medicine and Rehabilitation
Board Certified Interventional Pain management

cg
Offline

I have to say that this has been the forum with the most information on how to use Ctrac I have found. I took the time to read all the postings since I am trying to decide on the best way to go about treating carpal tunnel. I did read the study from Pulvertaft and curiously, same as in this thread of postings, findings contradicted themselves. There is a posting that states that even with relief of symptoms, the device is a waste of money. Then, even though there are a few postings stating that Ctrac has helped, the replies insist on the need for more research. There is a critique of the manufacturers biased research results, (which I was able to read on their website), still the Pulvertaft study is done at a surgical institution which will not be interested on finding any device that will steer patients away from what they do. The Pulvertaft study had a small number of subjects and they used controls. They state in their results that there will be an error in the study because of the limited number of study subjects. The number of study subjects was determined by the Ctracs donated for the study, not by the study design. If they would really have look for significant results they would just have enrolled the number of subjects needed for a study to have significant findings.
In the end they go ahead to say this is a good option for non invasive treatment, but the message in the abstract says otherwise, that is it not worth the try, since the difference between using Ctrac vs using a conventional splint is not statistically significant.
So, my interpretation of the Study and the information I have found on the net is that this is a product that will have a positive impact on the right patient, that is, a patient correctly diagnosed by a physician, and that does NOT have any of the contraindications mentioned by the manufacturer. I think that for the patient that it saves the surgery the statistical findings of a study will not matter. And they can always return it within 30 days for a refund.

jeremydpbland
Online

1 ) Dr Porrata - if you do not amend your posting to declare your financial interest (or absence of it) in C-TRAC I will delete the message in its entirety as advertising. If you are the inventor/manufacturerr of the device and the author of Porrata et al 2007 then the reader should know this and with a suitable declaration I will allow the message to stand as some of the issues raised are worth discussing.

2) Quoting the numbers from the paper as showing differences is obfuscation. The differences between the two groups did not reach statistical significance. The correct interpretation of this is that there was NO detectable difference between the two treatments. It is true that there MAY have been a difference between the groups too small to detect with this sample size but Storey and Burke correctly point out that the claim made for the C-TRAC is that it is as effective as surgery - not that it is just as good as an ordinary splint. The trial was adequately powered to detect a therapeutic effect similar to that of surgery and did not find one.

3) It is unlikely that there is a major financial bias on the part of these surgeons as UK hand surgeons do not derive the majority of their income from carpal tunnel surgery and generally have plenty of other things to do but there probably is a general bias among hand surgeons in favour of surgery as the ideal treatment for CTS. This was not a trial comparing surgery with C-TRAC however.

4) The line from the conclusion which you quote means exactly what it says ie C-TRAC is an alternative to a coventional splint.... NOT an alternative to surgery (and a relatively expensive alternative at that)

5) My own last posting on the subject in this thread is not a quote from the abstract but a 1 sentence summary of the findings - a fuller version (I too have read the full paper of course) of my assessment of it appears in the alternative treatments page. There is no true discrepancy between the abstract and the full article.

6) A type 2 error, in statistics speak, is the failure to reject a null hypothesis - sometimes referred to as a false negative - failure to detect something which was really there. In this case the small sample size means the study could not detect very small differences between the two treatments.

7) The UK cost of the C-TRAC at the time of the article was £130-00 but the cost for it's use over 1 year including replacement of faulty ones averaged £146-25 compared to £13-20 for conventional splints calculated on the same basis. I note that the US cost of the device has now fallen considerably and will be adjusting my paragraph on it in alternative treatments accordingly.

8) Your final paragraph is simply wrong - the trial did not show that more patients avoided surgery in the C-TRAC group - there was no statistical difference between the groups and the actual numbers shown in figure 1 could easily have arisen by chance. You are not agreeing with the paper at all and it should be pointed out that ANYTHING can be decribed as an 'option' for patients who do not want surgery - that does not mean that it is a demonstrably cost effective option. I do however admire the confidence shown by your money back guarantee and I see that at least one patient on here has taken advantage of it.

JB

jeremydpbland
Online

'cg' You are making almost exactly the same comments as Dr Porrata - are you related? I have responded in full to him and you should read that reply. Note especially that Storey et al did not say that the C-TRAC was a 'good' option for non-invasive treatment - only that its effect was equivalent to that of an ordinary splint. Being the same as a standard treatment (while costing 10x as much and possibly having more side effects) does not constitute a 'good' treatment. I believe we now have three user reports on the forum, one patient who found it useful, one who did not and one equivocal - what is clearly needed is a lot more. By all means go ahead and buy a splint and report back on how it influences your symptoms. Ideally complete my symptom questionnaire at the outset and then do another symptom severity score once a month for a year - though not a trial it would all add to the woefully inadequate evidence base for this device. JB

porratah
Offline

I provided the disclosures as requested.

jeremydpbland
Online

Thankyou. Your device is an interesting approach to CTS which I believe still deserves further study but at present the evidence available to support it's use is inadequate. The Storey trial is not perfect by any means - most especially there was no attempt at blinding either the patients or assessors. It does however represent a significant addition to the very limited available literature. JB

porratah
Offline

Dr Bland,

Greatly appreciate your dedication and the time and effort you put into this blog.

I see you acused me of obfuscation or confusing the numbers from the study.

I did not change or make up anything up. I reported what figure 1 of the study shows, that 9 of 21 patients in the C TRAC group asked for surgery vs 13 of the 18 patients in the BWB group that asked for surgery. Everybody and anybody can go to the article published by the Pulvetaft Hand Center and count how many patients had surgery in the C TRAC group vs the BWB brace group and come to their own conclusions. The numbers are there and were published. We just pointed the obvious that the patients in C TRAC group had less surgery that the BWB group.

I see your interest in economics of health systems. You stated that C TRAC is very expensive, lets see.

C TRAC

It costs 150 dollars. The Pulvetaft Hand Center does about 3000 Carpal Tunnel Surgeries a year.

Using C TRAC on all those patients will cost $450,000. Based on the Pulvetaft study 42% of the C TRAC users asked for surgery, that would be 1260 patients at a cost of $1100. That would total $1,836,000 in total expenses plus rehab and time out of work, etc.

BWB brace

It costs $20 and just $60,000 to put on 3000 patients. But, 72% in the study went to surgery in the BWB group that would be 2160 patients at a total cost $2,376,000 total expenses. Add to that the pre-op eval, therapy before and after surgery, complications on 6% of the patients including RSD and infections, and, time out of work between 19 and 29 days.

I do not think C TRAC is more expensive and it is very likely the NHS would like to save this kind of money.

What is not so obvious in the study is the use of the median of the values instead of the mean values for Levine Symptoms severity scale and Levine Functional scale.

The Levine scales were designed to evaluate Carpal Tunnel Syndrome Symptoms and as a follow up measure of improvement. The scales , as reported by Levine et al are reproducible and reliable and are reported as mean improvemnt, not as median. Statistically these are very different things as you well know and could dramatically affect the results of the study.

Is it true the Pulvetaft Hand Center study on C TRAC was used by the NHS to evaluate if C TRAC was suitable for the UK population?

Maybe the results of this study should be reevaluated by the NHS.

Financial Disclosure:. I invented C TRAC and I have a financial interest.
This is not advertisement.

Humberto Porrata MD
Inventor C TRAC
Partner Carpal Doctors LLC
Fellowship Trained Interventional Pain Management
Board Certified Physical Medicine and Rehabilitation
Board Certified Interventional Pain Management

jeremydpbland
Online

Dr Porrata - I am afraid you are wholly missing the point about the trial results. The findings are what they are and no-one is disputing the measured numbers. What you are conveniently ignoring is the statistics which are telling you that these numbers could have resulted from pure chance rather than any beneficial effect of the C-TRAC. Until you produce statistically sound evidence that C-TRAC is considerably better than an ordinary splint then the obvious policy should be to try patients with an ordinary splint before surgery. I'm afraid there is no getting around the findings. The Pulvertaft study - so far the only independent randomised trial of C-TRAC, whatever its failings - was unable to show a significant difference in outcomes between C-TRAC and an ordinary splint. This places the onus firmly on you to produce some better evidence - not try to misrepresent the results of this trial by inviting readers to consider statistically insignificant differences in numbers as representing evidence of a benefit. The obfuscation lies in quoting the numbers from trial accurately... but without the critically important bit of information that the difference seen did not reach conventional statistical significance. JB
 

ML
Offline

I feel I must point out the following: When I received my C trac the instructions that are here in front of me as I write state and I quote " Repeat the process 3 times a day for 6 weeks " I have carried out the instructions exactly as stated. There is also a yellow sticker on the mould in which you insert the affected hand which states and I quote again " If symptoms increase or feel no relief contact your physician.

I do not consider my treatment successful when after using this for this a period of 6 weeks my symptoms return after ceasing only for two days. So yes I would consider it a waste of money. I cannot return the device because obviously it is out of the 30 day money back guarantee.

This is not a contradiction as suggested by someone else here.

Am I seriously expected to use this every day indefinitely to keep the symptoms at bay. that to me is not a success .

I will do what it states on the yellow sticker now.

When I was first diagnosed with mild CTS I mentioned C trac to my Doctor. He told me it would be a waste of money. I wish I had listened.

jeremydpbland
Online

Dr Porrata - One other point about the Levine Scales. My reading of table one in Storey's paper is that the numbers quoted for the baseline SSS and FSS are means, not medians. The table caption refers to median values for continuous variables - except as indicated otherwise... and the individual lines for SSS and FSS are clearly indicated as mean +/- SD. In table 2 they appear to have quoted the median reduction and interquartile range - the reason for which is unclear from the paper but is likely to be because the distribution of the data is non-gaussian - without the raw figures we cannot tell. I often have reservations about the analyses I do myself with these scores because they are bounded scales - values cannot fall below 1 or rise above 5 and this often gives rise to odd distributions. JB

cg
Offline

I am not at all related nor I am a carpal tunnel patient. I am a health practitioner here in the USA and I have come across Ctrac several times through fellow physicians, patients and advertisement. I do use other orthotic devices in my office as well, and this one looks to be a new approach worth trying. What I have been doing is gathering more information about it and this blog seemed interesting.
It is usually the case that there will be no similar points of view in the analysis of a research paper and the conversation turns to be really interesting. It would be rare to find an agreement on this issue.
I just thought that my thoughts as a practitioner would be appreciated. I still think that there is not good evidence against the device and would like to see better evidence trials on it, but what I have found definitely brings a lot of attention to it. I think I will offer it to patients and let them make an informed decision on it. They can return it, which is more that we can do with any other device in the market or with any medication we commonly use. The FDA has given it clearance and this device is "over the counter", but as with aspirin or paracetamol, we need to give patients some guidance on its use.
If the blog is only for user patients, then please ignore my comments and sorry for the mistake. If I have patients use Ctrac I will direct them to the conversation.

jeremydpbland
Online

I'm happy for healthcare professionals to contribute to the site but we try to practice evidence based medicine and the content of this site reflects that. One of the principles is that we do not recommend new treatments until there is positive evidence telling us that they are better than what is already available. It is not up to the medical world to produce evidence AGAINST a treatment - the onus lies upon those proposing it to produce evidence FOR it.

It is rather worrying that both you and Dr Porrata have misconstrued the findings of the Pulvertaft trial. Considered as evidence based medicine it did NOT prove a difference between the two treatments. This is not just a matter of different interpretations of a result by two heatlh professionals - it is basic statistics. To put this in a very simple way for the public reading this - if I throw two dice and one comes up with a 5 and one with a 2 that is not 'evidence' that the '5' dice is a better scorer than the '2' dice, even though in that throw the actual performance of the two dice was different. Similarly in the Pulvertaft trial the actual performance of the two devices as measured on that occasion was different - but the statistical analysis of the numbers shows that those results would be expected to occur purely by chance quite frequently. JB

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies. Find out more here.

close