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Internal report
Crystal Plaster Double‐Blind Test
Bo Nordell & Hans Hede
Division of Water Resources Engineering
SE‐97187 Luleå University of Technology
March 2015
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Crystal Plaster Double‐Blind Test
Hans Hede1 and Bo Nordell2
March 2015
Summary
This report summarizes the background, development and testing of the Crystal Plaster (CP),
which refers to a (crystal) patch in which tiny quartz crystals are the active part in reducing
pains. The physical background is the piezoelectric property of bone, i.e. bone subjected to
pressure variations generates an electric current. The opposite, the piezoelectric effect is also at
work, which means that if bone is subjected to an alternating electro‐magnetic radiation then
the bone will respond by volume changes and corresponding mechanical stress. The
piezoelectric crystals of the CP are in different ways interacting with the corresponding
properties of the body.
It would be possible to read out much more of the test results from the CP tests that were made
in 2006‐2007. In any case, the performed study shows clearly that the Crystal Plaster reduces
nociceptive pains. We can see that the placebo effect is adding to the results but the test also
shows a clear difference between the Placebo and the real Crystal Plaster in favor of the real CP.
1/ Eng. Hans Hede CEO 2/ Prof. Bo Nordell
Crystal Plaster ltd. Renewable Energy Group
FIN – 66600 Vörå Div. Architecture and Water
FINLAND Dept. Civil, Environmental and Natural Res. Eng.
Mobile: +358 (0)407157864 Luleå University of Technology
[email protected] SE-97187 Luleå, SWEDEN
Phone: +46 (0)920 491 646
Mobile: +46 (0)725 390 736
http://www.ltu.se/staff/b/bon
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Crystal Plaster Double‐Blind Test Background
History
Crystal Plaster (CP) refers to a (crystal) patch in which tiny quartz crystals are the active part in
reducing various pains. The physical background is partly because of the piezoelectric property
of bone, i.e. bone subjected to pressure variations generates an electric current. The opposite,
the piezoelectric effect is also at work, which means that if bone is subjected to an alternating
electro‐magnetic radiation then the bone will respond by volume changes and corresponding
mechanical stress. The piezoelectric crystals of the CP are in different ways interacting with the
corresponding properties of the body.
The embryo of the CP started to grow in 1998 during discussions between Prof. Bo Nordell,
Luleå, Sweden, and Engineer Hans Hede, Vasa, Finland. Among the topics discussed were
Nordell’s dowsing studies and the fact that the human bone is piezoelectric in vivo. His
conclusion was that the piezoelectric property of bone was behind the mechanism of dowsing
reaction (Nordell, 1988).
From this fact we speculated about whether the human body, including the bone, has been able
to adapt to the strong increase in electromagnetic radiation during the last century, or if it could
possibly be damaged under such conditions. From an evolutionary point of view, humans are
adapted to small amounts of electromagnetic radiation emitted from Earth and also from space.
Today we are surrounded by huge amounts of electromagnetic radiation from various sources.
If bone is harmed by such additional electromagnetic radiation then rheumatic diseases could
be a symptom of such damages. Our speculations continued on the possibilities to shield bone
from exposition of such radiation.
Electromagnetic radiation cannot be removed from our modern society. On the contrary it is
strongly increasing but maybe it would be possible to prevent that radiation reaches our bones.
A "Faraday cage" could be used but seems to be too impractical. Then the idea struck us to use
piezoelectric materials at the surface of the skin, This would then absorb some of the electro‐
magnetic radiation and thereby prevent part of the radiation from reaching the bone.
After numerous attempts, we developed bracelet of stiffened polyamide velour coated with
piezoelectric crystals on one side. The bracelet was fastened to the skin by Velcro.
The first attempt was made on Hede's stepmother Kirsti Hede who suffered from severe
rheumatoid arthritis in her hands and ankles. The disease causes difficult pains that had
disturbed sleep for several years. Four bracelets were fastened around the hands and ankle
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joints so that the crystals were pressed against the skin. The results of the experiment were
astounding. Kirsti Hede called the following morning and told that she for the first time, of
countless nights, had slept undisturbed through the night and she wake up refreshed. Half an
hour after applying the bracelets in the evenings at bedtime the pain started to reduce become
so weak that the old lady could sleep.
Encouraged by the results, we made tests also on other people in our circle of acquaintances
who suffered from rheumatism. In most cases, the results were positive and similar to that of
our first test with Kirsti Hede.
One disadvantage with the bracelets was that they could chafe and irritate the skin especially as
the edges tended to be sharp. Attempts were made to use medical tape (wound tape) or
surgical tape used to protect the wound edges.
Different amount of crystals were applied on the adhesive surface of the tested patch on the
patients. It was found that the amount of crystals that was glued onto the patch could be
limited to a small 12 mm circle. We fund that it was enough to use four patches, close to the
aching area, to ease the pains.
At this stage all the patches were handmade and we never intended to commercialize this
technology. All tests that and attempts that were made during the first years were done without
any other interest than just curiosity about how it worked.
Commercialization
The positive test results meant that increasingly more people contacted us as they wanted to
buy CP for their ailments. All patches until now had been manually made and the increasing
demand required a more efficient production. So, we started to think about a developing an
apparatus for semi‐automatic production of the patches. This first patch production line was
designed and built 2003/2004 and produced patch on a roll. However, the individual patches
were manually cut with scissors. During the same year we also submitted the first patent. Vörå
R & D was manufacturing the patches which were sold mainly in Finland and Germany. In 2006
Crystal Plastics Ltd, a company owned by Hede and Nordell, overtook the production.
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How it work – theories
Since the positive test results were in line with our first theories, we assumed initially that our
theories were correct and that the pain relief was due to the reduction or shielding of
electromagnetic fields.
After the CP has been sold on the Finnish market for some time, it turned out that we had
several groups of patients who had received pain relief for other pains, i.e. they did not have
any rheumatic disease. Examples of such pains were alleviated pain after operations and
contusions. This was not in line with our initial theories and the number of such aberrant cases
was increasing.
After a CP lecture for nurses and doctors in Helsinki we were contacted by a doctor who were
interested in our patches. She expressed that the function of the CP seemed to have much in
common with another pain relief method, explained by the Gate Control Theory (GCT).
The GCT was first suggested by Melzack and Wall (1965). The theory is one of the cornerstones
of pain research and utilized e.g. in pain management with TENS in pain clinics. The theory
assumes in its simplest explanation that you can block certain types of pain signals by
stimulating other non‐pain‐producing nerve endings. The CP generates, due to its piezoelectric
crystals, small electrical currents in the skin which stimulates specific nerve endings. These are
also stimulated by the sharp crystals which penetrate the outermost layer of the skin.
The stimulation blocks such pains which by their nature are not acute but long lasting. Such
pains could be "grinding", "vibrant" suffering from e.g. infections, cuts, bruises, burns, etc. The
pain is by its nature nociceptive and stimulation takes place via the beta nerve endings in the
same hem.
This GCT explains very well why analgesia worked on all the different types of pain that we had
received positive feedback on (they were all of nociceptive type) but it could also explain why
pain relief does not worked in other cases. Many alternative pain relief methods used today
probably work in the same way for instance methods that use heating/cooling, spice patches
etc. They all seem to stimulate the beta nerve receptors.
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Testing the theories
After we understood the function of the patch, we want to obtain some kind of proof that
function theory was correct. The first tentative attempts to test the patches had been done
already 2000‐2001 at the Association for Rheumatism in Västerås, Sweden. See below.
Vörå 2003-09-21 / hhe Testing of how Crystal Plaster (CP) works for relief of pains caused by rheumatic diseases During the fall and spring of 2000 the CPs function as a pain reliever was carried out in Västerås, Sweden. The work was led by Mr. Ture Söderström, Västerås. The performed test was not a double-blind test but rather a subjective test in which the patient himself describes how he/she perceives pain change after using the CP. The scale included the numbers 0-5, where 0 is no pain relief and 5 means that all pain is gone. The grades 3, w and 5 are considered as good results. The test subjects also assessed how the CP worked in different body parts. In presenting the results, only the best result for the disease have been recorded. So, if a patient with Rheumatic Arthritis (RA) have given 5 (fingers), 4 (shoulders and one knee), then only the grade 5 was recorded for that person’s RA pain. At a later stage the evaluation was considering the different body parts. The tests included a total of 54 test persons of which two were interrupted and five test results were regarded unreliable. These have not been reported. Therefore, our test (and report) includes only 47 test persons. Out of these 47 are another 9 people have symptoms that cannot be directly classified as rheumatic diseases e.g. pain in a body part without any diagnosis, whiplash etc.
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The test method and obtained results are not scientifically correct but give anyhow strong indications that the Crystal Plaste is a pain relieving method Vörå 2003-09-21 Vörå R&D, Hans Hede
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Crystal Plaster Double‐Blind Test
The first tests in 2003 indicated clearly that the patch worked as an analgesic for rheumatic
pains. In 2006 we started planning for a double‐blind test that would provide clearer answer
and also give us a little more scientific weight behind the results. The tests were conducted with
Valioravinto, one of Finland´s leading health food companies in, which marketed the patches
within Finland.
The cost of double‐blind testing, conducted by accredited universities and research institutions,
was found to be greater than Crystal Plaster’s annual turnover. So, it was decided that Crystal
Plasters in collaboration with Valioravinto and a medical doctor would conduct the double‐blind
tests, at a much lower and acceptable cost. This decision obviously reduced the value and the
scientific level of the test but would still give us more information about the patch. We also saw
this new test would provide a basis for future new tests.
Search for patients
Patients for the double‐blind tests were found by publishing an article about how Crystal
Plastics relieves pain in two local newspapers, Vasabladet and Pohjalainen. In this article is s
mentioned that a double‐blind test would be carried out in the Vaasa region (Radison SAS
Vaasa) in the near future and that interested could sign up. The article resulted in more than
100 potential patients.
Selection of patients
Based on our experience from the Västerås tests it was decided that only patients who were
likely to have pain of nociceptive type (primarily from rheum) would be included in the tests.
This had already been stressed in the newspaper articles for the potential patients. All patients
were examined by a doctor who stated to which disease group the patient belonged, main
dysfunction and current medication. About 10% of the potential patients were rejected.
The placebo patch was made of glass spheres that were not piezoelectric or sharp but had the
same size and colour as the real crystals. It was not possible to differ the placebo parches from
the actual patches, without investigating the patches in a microscope.
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Test setup
From the beginning it was planned that the tests would include the following:
Test 1: A one hour test to see if the patient could notice a difference between Placebo and the real Crystal Plaster.
Test 2: A 24 hour test to see if the patient could notice a difference between Placebo and the real Crystal Plaster.
Test 3: A three months test to determine the customer satisfaction after 3 months with the
real Crystal Plaster.
Test 4: A six months test to see the customer satisfaction after 6 months with the real
Crystal Plaster..
During the evaluation of Tests 1 and Test 2 it was clearly seen that the patients were scared of
deciding how the patch worked. Patients were afraid of being labelled "stupid" when they
claimed they had pain relief from a plastic that turned out to be a placebo patch.
In Test 3 and Test 4, which only included the genuine Cristal Plaster (with the patients’
knowledge) the result can be regarded as more reliable.
Test 5: In order to get more reliable results, it was decided to make a two‐week test series
with genuine Crystal Plaster and the Placebo patch as before. The difference from before
was that the patients were informed that both patches were genuine, but that one patch
was an improved version. Thus, the patient´s task was to decide which patch that worked
better for him / her. With this arrangement the risk of choosing the "wrong" answer was
eliminated. Consequently, the results were more reliable.
The distance testing was done on 61 of the previous participants. The material was sent to the
patients and the results were reported (collected) over the telephone.
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Test parameters
Test 1‐3 ‐ documentation of all participants
V1 Patient number (consecutive numbers regardless of gender)
V2 Age
V3 Sex (Male = 1, Female = 2)
V4 Disease group (Arthros = 1, spondylosis = 2, Arthrit = 3 Myositis, Tendinid, Tenosynovitis = 4)
V5 Location of (main) dysfunction (Neck Vertebrae Column = 1, Shoulder = 2, Dorsal Column= 3,
Lumbar Spine = 4, Large Joints = 5, Small Joints = 6)
V6 Current (main) pain medication. Paracetamol = 1, NSAIDs = 2, Euforic pain medication/opiate=3,
Antidepressant = 4, Medical specified against neurogenic pain = 5, combinations of the above = 6
V7 Rheumatoid medication (Yes = 1, No = 2)
V8 Pain assessment (VAS) at rest when applying the patch. (0 = pain, 10 = infernal pain)
V9 Pain assessment (VAS) in motion when applying the patch. (0 = pain, 10 = infernal pain)
V10 Pain medication the day of the patch was applied (1 = Yes, 2 = No)
V11 Patch type applied 1 or 2 (to be completed by the test personnel during application)
V12 Patch placement. Neck Vertebrae Column = 1, Shoulder = 2, Dorsal Column = 3,
Lumbar Spine=4, Large Joints= 5, Small Joints=6)
V13 Number of patches on patient
V14 Pain assessment (VAS) at rest for one hour. (0 = pain, 10 = infernal pain)
V15 Pain assessment (VAS) in motion after an hour. (0 = pain, 10 = infernal pain)
V16 Pain relief after 1 hour. Yes = 1, No = 2
V17 Side effects after 1 hour. Yes = 1, No = 2
V18 Pain assessment (VAS) at rest after 24 hours. (0 = pain, 10 = infernal pain)
V19 Pain assessment (VAS) in motion after 24 hours. (0 = pain, 10 = infernal pain)
V20 Pain relief after 24 hours. Yes = 1, No = 2
V21 Side effects after 24 hours. Yes = 1, No = 2
Documented after 3 months of use.
V22 Patch use. Regularly = 1, Sometimes = 2, Stopped due to no effect = 3
V23 Pain assessment (VAS) at rest during the last 2 weeks (0 = pain, 10 = infernal pain)
V24 Pain assessment (VAS) in motion during the last 2 weeks (0 = pain, 10 = infernal pain)
V25 Pain relief after 3 months. Yes = 1, No = 2
V26 Side effects after 3 months. Yes = 1, No = 2
Test 4: Documented for each participant after 6 month of use
V27 Pain assessment(VAS) at rest during the last 2 weeks (0 = pain, 10 = infernal pain)
V28 Pain assessment(VAS) in motion during the last 2 weeks (0 = pain, 10 = infernal pain)
V29 Patch use. Regularly = 1, Sometimes = 2, Stopped due to no effect = 3
V30 Pain relief. Yes = 1, No = 2
V31 Side effects, Yes = 1, No = 2
V32 Patient has stopped using the patch. Yes = 1 No = 2
Test 5: The testing was limited to one question.
Which patch is the best? Patch 1 = 1, Patch 2 = 2, No difference = 3
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Test procedure
Test 1 and 2 were conducted at SAS Radisson Vasa. The patients were divided into two
groups, with one group were tested in the morning and the second group in the
afternoon. The test personnel consisted of two testers from Crystal Plaster Ltd and a
doctor Michael Eklund, chief physician in physical therapy of the Malmska hospital in
Pietarsaari Finland.
The tests began by informing the test persons about the test procedure.
The doctor filled‐in the form containing V1 through V10, see Test Parameters.
Tester No 1 chose to give each patient patches from one of the two different patch
boxes. The patches were labelled 1 or 2. The Tester No 1 did not know which of the
patches were genuine or placebo. Tester No 1 filled V11 through V13.
After some time Tester No 2 interviewed the patients and filled in V14 through V17.
The following day the patient and Tester No 2 met again at the Radisson SAS Vaasa. The
tester filled in V18 through V21 in the form.
Test 3 took place 3 months later. Tester No 2 and No 3 from Valioravinto were then
interviewing all the test persons over telephone and thereafter filled in V22 through V26.
Test 4 took place after the CP had been used for 6 months. Tester No 2 and No 3 from
Valioravinto were interviewing all the test persons over telephone and thereafter filled
in V27 through V32
Some data are missing, for various reasons, in the documentation of variables V22 to V32 e.g.
the patient stopped using the patches because they did not work; and such. A VAS analysis was
therefore in this case unnecessary. In some other cases the test persons ran out of patches
before the completion of the test.
Test 5 was performed so that Valioravinto did a printed Questionnaire that was sent to
61 of the former patients. The patients received two different patch packages labeled 1
and 2. After 2 weeks, patients sent back the questionnaire to Valioravinto. The
document included four questions of which only the selection of patches is available in
the report. The other questions were: 2) Where on your body did you use the patch. 3)
Any other comments. 4) Name
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Evaluation of CP Double‐Blind Tests
An updated analysis of the CP tests in the spring 2006 and the winter 2007 is enclosed. The
individual parameters are plotted in graph form next to the list of variables.
It is clear that the longer the patches are used, the more the pain shifted towards lower VAS
numbers which means less pain.
V8, Share of test persons (%) and their degree of pain before any patch where used. 0=no pain; 10 = infernal pain
V14, Share of test persons (%) and their degree of pain after one hour testing, 0=no pain; 10 = infernal pain
The bar graphs for parameter V8 (initial) and V14 (after one hour) shows very little difference
form the initial pain and the pain that was experienced after one hour with the patch.
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V18, Share of test persons (%) and their degree of pain after 24 H testing, 0=no pain; 10 = infernal pain
V23, Share of test persons (%) and their degree of pain after 3 months testing, 0=no pain; 10 = infernal pain
V27, Share of test persons (%) and their degree of pain after 6 months testing, 0=no pain; 10 = infernal pain
The bar graphs for parameter V18 (24 h), V23 (3 months) and V27 (6 months) clearly show how
that the CP reduces the pain with time.
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V16, Share of participants (%) who experienced pain relief after one hour.
V20, Share of participants (%) who experienced pain relief after 24 h.
V25, Share of participants (%) who experienced pain relief after 3 months. V30, Share of participants (%) who experienced pain relief after 6 months. .
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In general we can say that the difference between the genuine and placebo patches emerges
when the patches are used for longer than 24 hours. The difference between placebo and the
patch is insignificant for shorter time.
In this Placebo test (T2a) the participants got a Placebo patch or a real CP. However, the test
persons were told that both were real CP but of different types, one old CP and one new
improved version. This test showed stronger correlation in favor of the real CVP than the
previous Placebo test where it seemed like the test persons where afraid of making a fool of
them self by choosing the “wrong” patch. Since our studies show that the effect of the CP
increases with how long time it is used we have all the reasons to believe that a Placebo test
over long time periods would become even more favorable for the CP.
T2a, Comparison between Placebo and the real CP after 2 weeks of testing. 1 = Placebo 2= CP
It is possible that the results are unknowingly influenced in double‐blind tests. To obtain more
conclusive evidence on how efficient the CP is we should perform a double‐blind test over a
longer period, following best scientific standards. Even then there would be an element of
uncertainty about the results.
It would be possible to read out much more of the test results from the CP tests that were made
in 2006‐2007. In any case, the performed study shows clearly that the Crystal Plaster reduces
nociceptive pains. We can see that the placebo effect is adding to the results but the test also
shows a clear difference between the Placebo and the real Crystal Plaster in favor of the real CP.
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REFERENCES
Nordell, Bo (1988). The Dowsing Reaction Originates From the Piezoelectric Effect in Bone. Presented at
the 6th Int. Svedala Symp. on Ecological Design May 19‐21, 1988 Svedala, Sweden.
http://pure.ltu.se/portal/files/101715913/dowsing.pdf
Melzack R, Wall PD. (1965). Pain mechanisms: a new theory. Science. 1965 Nov 19; 150(3699):971‐9.