TESTS & REVIEWS
THE PRODUCT TEST
Before founding LUNEMED, the company that deals with the construction of Carpalello, a product test was conducted in order to verify that it could be effective on a good part of cases of Carpal Tunnel Syndrome.
The device was born and had been effective with the inventor's father, but before investing more resources, it was correct and logical to check its effectiveness on a wider range of cases.
This product test cannot be considered a scientific test, as it was started for a validation of the investment, a wise verification verifies that the benefits offered were received by a significant percentage of people affected by the disease.
Not being a rigorous scientific test that had a value that could be published in specialized journals, we did not start with a precise protocol, however considering the numbers of cases collected and the duration of the test, these results are to be considered extremely interesting and worthy of further investigations.
Towards the end of 2017, the first industrialized products in series were realized, with the aim of giving them to anyone who reported having this problem and the will to try it without commitment.
With the collaboration of local doctors and pharmacists, in a short time about seventy people who agreed to verify their effectiveness were identified.
Cases had been accepted in which volunteers declared to suffer from problems related to carpal tunnel, but some of them have a diagnosis confirmed by clinical tests, with others instead it was later discovered that they suffered from other problems, so the group was reduced to fortynine persons.
This miscellany of users allowed us to understand at first the pathologies for which the product was not indicated, such as, for example, cases of arthrosis and arthritis of various kinds.
The use by those who do not suffer from STC does not cause any benefit, while on the contrary it can significantly increase the pain of other pathologies, which disappears immediately once the device is removed.
Carpalello is not dangerous at all and does not generate irreversible damage.
The test group
- Nr. 49 participants
- Age: 38 years the youngest, 93 years the oldest, average age 62 years
- Composition: 10 men (20%), 39 women (80%)
* A 73 year old man who reports having tried the product for a few days but who does not notice any improvement; however, the date for the surgery was already set a few weeks later.
** a 76 year old woman who starts using the device with benefits, but who has to stop after a few weeks for pain caused by osteoarthritis. She does not undergo surgery, but cannot be considered satisfied patient.
*** a 62 year old woman, already recently operated on her left hand, decides to test the product for her right hand. She reports significant benefits and she is comfortable with the device, but unfortunately after a few months she still has to undergo surgery. She would like to report that her syndrome was in a very advanced state and the surgery was also long and annoying, in order to be able to completely clean the area of the hand involved. However, she leaves positive feedback because for several months she managed to sleep better, and was able to face the surgery in a better physical condition than her previous experience with her left hand.
The study methodology
All participants were interviewed several times.
The first time a few days after the start of use of the device, in order to verify the correctness of the size chosen, if the method of use of the device was clear, and of course for any other possible suggestions and advice.
Then other periodic interviews followed initially at monthly intervals, then with longer intervals, to ascertain the occurrence of progress, the improvement of the living condition or the onset of any problems.
The interviews showed that almost all the participants had benefited fairly quickly, some had noticed improvements already half an hour after use, while others had taken longer.
One aspect on which all those who suffered from it agreed were the nocturnal ailments: those who suffer from it usually wake up at the same time and struggle to get back to sleep, but by wearing this device they said they had started to sleep peacefully, almost always from the first night.
Some had said that before the test the hand was swollen, after 10-15 days of use, it had returned to normal size.
At this point, it became interesting to investigate and verify if the benefits were only temporary and subject to continuous use of the device, or if they are preserved even over time after a certain period of use.
This aspect has resolved itself over the months.
As time passed, the fact that some begin to forget to put it on began to emerge during interviews. If the forgetfulness happened in the initial periods of the test, they usually woke up at night and then put it on again, but after a certain period a certain period was found that they were well even without wearing it.
As a temporal indication for use, everyone was initially given a term around two / three months, an indicative and generic term since the duration of use is singular and depends on the personal situation of each of them.
In any case, it emerges that everyone understands for themselves when they can do without it, becoming use only one more commitment than additional benefits.
Significant cases exposures
The case with the faster solution refers to a 51-year-old woman who used it for about twenty days.
The case with the more dilated solution over time, refers to a 42-year-old man who used it for five months. It should be added that this man suffered from the carpal tunnel problem because of his work (he reported being the only employee who had not yet undergone surgery) and his orthopedic surgeon, unable to operate soon, advised him to try Carpalello.
The man complained that he hadn't slept peacefully for a few months, before the test, and was one of the first testers. He collaborated with Ing. Negretto in particular, allowing himself to be monitored often both through interviews and thanks to the participation of his orthopedic surgeon, who showed serious interest in the real functionality of the device.
After five months, the patient reports that he is feeling well even without the use of Carpalello, and that the evolution of the symptoms depends a lot on what happens during the day, being the problem basically caused by the type of work remained the same.
A third major case refers to a 50-year-old woman who has been suffering from carpal tunnel syndrome for over twelve years. Her twelve-year-old electromyography indicated a rather pronounced CTS that had not improved over time.
She said that for twelve years she had been unable to sleep a whole night, that she had adopted a series of strategies to force herself to sleep with her hands in certain positions that would allow her a minimum of rest.
During the first interview, she reports all his amazement, when on the first night of testing she had slept all night without waking up. With great sincerity, she revealed that she had thought of a placebo effect, but after a week, during which she had really slept every night without problems, she had confirmed the real goodness of using Carpalello, thanking her satisfied.
The woman made continuous use of it for about two months every night, then simply realized that she could sleep without it.
After one year from test start
After one year from the application start, we then finalized the test result with two simple questions to the testers:
1) Had they also undergone the related surgery?
2) Were they satisfied and happy with the product enough to recommend it to those suffering from CTS?
1) Of the 49 participants, only 2 had undergone surgery.
2) Of the 49 participants, 47 said they were very satisfied and would certainly recommend it to those suffering from this problem.
These two results apparently coincide, but in reality they are partially because, as we can read from the NOTES of the participants table, we have a case of a man who had not found any benefits and had then undergone surgery shortly after, while we have a case of a woman who had had benefits, but had to undergo surgery because she was in an extremely advanced state.
The third case was a woman who had initially benefited, but then other pains had arisen due to osteoarthritis for which she had to stop using the device, so no surgey but we can not even say that she was satisfied.
After this research and field application, we can draw some conclusions listed below:
In the short term,
The device is effective in reducing symptoms in almost all cases
Effectiveness is noticeable quickly
The device is effective in reducing symptoms in both mild and severe cases
No contraindications were found in the use
All the people involved have not changed their lifestyle or even work during the test, and it is an important factor to consider because the syndrome can appear because of work, and disappear if you change it
A good part of the people involved in the test were workers. None of them needed to take sick leave from work because of CTS
If there are no improvements in a few days, or even if you experience pain and new discomforts, the use of the device, which in this case must be suspended, is a serious reason to investigate any other causes and pathologies with your doctor.
In the long term,
Considering the results one year after the start of use, the device in most cases has proved to be also decisive and to be able to avoid surgery. If the syndrome is not serious and is in its early stages, the chances of its effectiveness in this sense are very high.
So, based on the data collected and the experience gained, this device could be a valid solution for those suffering from this syndrome, a solution that acts quickly, without the use of drugs, easy and simple to use, with no contraindications found, and that in most cases it is able to avoid surgery.
The logical conclusion was to proceed with commercialization for its diffusion among potential patients.
The test performed and described above, served for the purpose of project validation, for the verification of the usefulness and effectiveness of the product, but cannot be considered a real clinical test such as to be published in scientific journals.
Speaking of the device and its effectiveness to various clinics and doctors, an important and prestigious Italian CTO has shown a certain interest, and has accepted to test it on 50 among its patients, after handling the relative practices and authorizations.
The approval by the various bodies responsible for carrying out the test took several months, and in December 2019 the test began. Unfortunately due to Covid-19, it has been suspended, but it will resume once this emergency phase is over.
If there are clinics, researchers or doctors interested in carrying out tests or replicating what was implemented by the aforementioned CTO, Ing. Negretto will be happy to collaborate and provide all the necessary tools. Please write to firstname.lastname@example.org
In 2019, LUNEMED starts selling the first devices by collecting more information and feedback from customers. The device was sold online on our website carpalello.it, and on Amazon, in addition to the classic stores such as Pharmacies and Orthopedic and Health Articles.
The increased contact with customers allows to confirm first of all the safety of the device, and also its effectiveness, in the order of magnitude of what was found on the first product test.
Here are some reviews from our customers who have agreed to make them public.
Ambra Jessica Passalacqua (VA-Italy)
Following surgery, Mrs. Ambra had to take medications that caused her hormonal imbalances, hence the appearance of the carpal tunnel syndrome. Not being able to rest anymore, on the suggestion of an orthopedist, she started using Carpalello and in a couple of months she was fine.
Gianluca Lo Monaco (CO-Italy)
Mr. Gianluca suffered from carpal tunnel syndrome due to problems related to his work. The orthopedist, after diagnostic tests, told him that if he wanted to recover he would have to undergo surgery. Gianluca was against the intervention for any risks that ensue. The orthopedist suggested that he try Carpalello, and with this device he was fine, and he did not change his job.
Lucia Andreola (SO - Italy)
Carpal tunnel syndrome has been a problem for many years, the first symptoms began at the age of 19 in the left hand, even the doctor at the time told me that it was unusual for such a young woman, and then spread in the over the years to both hands.
It has always been a present and constant disturbance, with more or less intense periods, but it has never prevented me from carrying out a normal life because the disturbance is present above all during the night hours, at the first hours of dawn so it has influenced more what else about the quality of sleep that has punctually interrupted by numb and tingling hand pain.
Of course, over the years I have tried everything: from infiltrations, stings, resorting to reflexology and osteopath.
I also performed several electromyography tests that highlighted and confirmed the diagnosis.
Three years ago I was determined to have surgery on my left hand. To date, I can say that I have completely solved the problem on this side but personally, the restoration of the functionality of the hand and the recovery were very long: about six months.
Last summer he proposed to me to intervene also on the right hand as it continues to give me big problems, when I found Carpalello on internet.
I had already used other braces in the past, wrist braces and the like, but they did not benefit me.
I told myself to try again and ordered it from the manufacturer's website.
Arriving after a couple of days I immediately wanted to test it and I spent my first night after many years without experiencing any disturbance. I could not believe it!
I therefore continued wearing it every night and I immediately noticed the benefits of Carpalello. In the following nights, I continued to record on a diary whether the disturbances were present or not during 50 nights, and the result was: 60% the disturbance had completely disappeared, at 30% it was present in a light form, and at the 10% was still present, whereas before the disturbance was present every night.
Now that I am at the age of 60, the disturbance, occasionally, still accompanies me, especially when I do not wear Carpalello, but in a very mild form.
Certainly, I'll not go under surgery for the right hand.
Carpalello is a very comfortable and easy to wear brace. Unlike other invasive braces, you don't notice you are wearing it.
Marco Schiavini (MB - Italy)
We purchased the product in 2019 to treat neuritis in the left hand that also involved the wrist. The problem was not directly related to the carpal tunnel, yet, using the glove regularly every night, neuritis healed within a few weeks.
We recommend the product also and not only for the treatment of inflammation in the carpal tunnel, the therapeutic effect, at least in our case, worked progressively reducing inflammation.
My partner and I are motorcyclists, we travel about 20/30 thousand kilometers every year and we are subject to great strain on fingers, hands and wrists.
We are happy to have found a valid help to the inflammations of these joints.