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[escepticos] Re: Imanes
En la red, he encontrado el proyecto del ensayo clinico del Dr. Vallbona.
Ahi va.
Post Polio Syndrome Research Study
by Baylor College of Medicine
1.PROJECT TITLE: A Pilot Study of the Effect of Magnetic
>Fields on Pain Control in Patients with Post Polio Syndrome
2.PRINCIPAL INVESTIGATORS: Carlton F. Hazlewood, Ph.D. Carlos
>Vallbona, M.D.
>
3.PARTICIPATING DEPARTMENT(S): Department of Molecular Physiology
>and Biophysics; Department of Community Medicine and Department of Physical
>Medicine and Rehabilitation, Baylor College of Medicine
>
4.GRANTING AGENCY: None at present
>
5.PERIOD OF PROJECT: September 1, 1994- August 31, 1995
>
6.COLLABORATING INSTITUTIONS: The Institute for Rehabilitation
>and Research (TIRR), Houston, Texas
>
7.LOCATION WHERE RESEARCH IS TO BE DONE: The Institute for Rehabilitation
>and Research (TIRR), Houston, Texas
>
8. RESEARCH PROPOSAL:
>
A. Background Information: The post polio syndrome occurs in
>a high percentage (about 35%) of polio survivors, approximately 30-to-35
>years after the onset of acute poliomyelitis. One of the typical manifestations
>of the syndrome is pain in the muscles initially affected by polio, as
>well as the muscles that seem to have been initially unaffected. The pain
>is considered to be due to myofasciitis secondary to progressive denervation.
>
In addition, most patients complain of joint pain. This is due to degenerative
>arthritis caused by age and by a longstanding asymmetrical load on the
>joints which results from the typical asymmetrical skeletal load distribution
>brought about by the muscle paralysis. Subacute or chronic sacroiliitis
>occurs very often, but many times it is not recognized because it is masked
>by other forms of low back pain. </P>
><P>Static and time-variable electromagnetic fields have been applied with
>apparent success in the management of pain in a variety of orthopedic
conditions,
>most commonly traumatic bone factures or surgical osteotomies. 1,2 Poorly
>documented reports on the usefulness of static magnetic fields in pain
>relief have been published. 3,4 Unfortunately, most of the studies on the
>application of static magnetic fields have been of the descriptive type
>and a search of the literature does not show any reports of scientific
>clinical trials. To our knowledge, the use of static magnetic fields has
>not been tried on post polio patients. </P>
>
><P>Anecdotaol reports of the benefits of these devices abound (even in
>post-polio patients who have reported pain relief to us), but the literature
>does not contain reports of well designed scientific evaluations of their
>effect. The investigators of this study have placed magnets on themselves
>on painful joint areas affected by arthritis and have observed significant
>benefits after a very brief application of magnetic discs (within minutes).
>Also, by applying the magnets to trigger points5 referred pain associated
>with that trigger point has been relieved within forty (40) minutes or
>less. </P>
>
><P>Static magnetic fields can be delivered to a localized area by placing
>magnets of different field stengths on the skin over the affected area.
>These magnets usually vary in strength from 300 to 500 Gauss, are disc-shaped,
>40 mm in diameter and 1.5 mm thick. The disc magnets can be kept in place
>by means of adhesive tape. A variety of magnets are commercially available.
>They have different shapes, but all of them can be easily kept in place
>over any selected area of pain (or trigger point associated with referred
>pain) on the post polio patient. (The specific magnets to be used in out
>study are the Bioflex Biomagnets with a pattern of cencentrically aranged
>circles of alternationg magnet polarity.) </P>
>
><P>The mechanisms of the effect of magnetic fields on soft tissues have
>not been elucidated. We postulate that in addition to the known effect
>of magnetic fields on the nuclei of water molecules, there could be a change
>in the tensile properties of cartilage, ligaments, and other soft tissue
>structures whick secondarily may relieve tension on arthritic joints or
>on chronically "inflamed" areas. Clearly, if subjective benefits
>of magnetic therapy are scientifiacally documented, detailed studies should
>be conducted to evaluated the local and possible systemic effects of magnetic
>fields. </P>
>
><P>The FDA has told us that it is permissible to use magnets in specific
>studies since there have not been any published reports of ill effects
>resulting from the external application of magnets over any part of the
>body. Furthermore, the World Health Organization reports "the available
>evidence indicates the absence of any adverse effects on human health due
>to exposure to static magnetic fields up to 2T".6,7 (2T=20,000 Gauss).
></P>
>
B. Purpose of the Study: </B>This pilot study aims at assessing on
>a double blind basis whether or not the application of static magnetic
>fields to elective points of pain or to trigger points for areas of referred
>pain will result in a significant improvement of subjective pain levels
>in patients with post-polio syndrome. C. Description of the Study: </P>
>
><P>We intend to evaluate firty (50) patients seen in the TIRR Post Polio
>Clinic by one of the investigators (Carlos Vallbona, M.D.). Those who complain
>of pain in specific areas of the body will be invited to participate in
>the study by the attending physician of his designee (usually the Clinic's
>physical therapist or nurse). The purpose of this study will be thoroughly
>explained to the patients and those who agree to participate. </P>
>
><P>Those patients selected for the study will be randomized to receive
>active devices (magnetized discs) or inactive devices (placebo). All the
>devices (active and inactive) will be kept in labeled boxes from which
>they will be pulled out at random before applying them to the patient's
>skin above the pain area. All the devices will have identical size and
>shape and their magnetic activity will be known only by the manufacturer
>by a code number affixed on each device. The code number used in each instance
>will be duly recorded in a log kept by the investigators. Thus, neither
>the investigators, the clinic personnel, nor the patient will know which
>disc is magnetically active until the code is broken at the end of the
>study. An observer will be assigned to each room to ensure that neither
>patients nor investigators will check for magnetic activity of the discs.
></P>
>
><P>Prior to the placement of the placebo or magnetic disc, the patient
>will be asked to manifest the intensity of pain in the area to be treated
>either by answering the McGill Pain Questionnaire* and by using a simple
>0-10 point scale. After the disc (magnetically active or inactive) has
>been in place for 40 minutes, the patient will be asked to rate the pain
>in the same area on a scale from 0-10. The disc will be removed and returned
>to the box for future use. (The magnetized discs do not lose their magnetic
>activity in spite of multiple applications over an extended period of time.)
></P>
>
D. Study Population:</B> We intend to recruit fifty (50) patients
>from the Post Polio Clinic at TIRR. The patient's ages vary from 40 to
>70 years. The women:men ratio is approximately 60:40. Because the magnets
>that will be tested are between 300-500 Gauss and because the magnetic
>field strength decreases as the square of the distance, grossly obese patients
>will be excluded from this study. </P>
>
9A. DISCOMFORT TO PATIENTS/POTENTIAL RISKS:
>
><P>None of the papers reported in the literature indicate that the application
>of static DC magnetic low fields (under 1,000 Gauss) causes any discomfort
>or any ill effect to the patients. One might postulate that by freeing
>the patients of pain, they might have a tendency to carry out more strenuous
>physical activities than in the past, and this could be a long-term detriment
>to the preservation of energy in the post polio patients. Since these patients
>return to the Clinic for follow-up on a regular basis, we will monitor
>this possible effect. Also, we will place telephone calls to the patients
>a few days after the magnets have been applied to assess their levels of
>discomfort. </P>
>
9B. COSTS:
>
><P>The only cost involved for the investigators in the study will be those
>of the magnetic discs or placebos. The manufacturer will make the discs
>available to us at no cost for this pilot phase. The patients will not
>be charged for the participation in the study; however, the patient will
>be expected to pay for the usual post polio clinic visit independently
>of the study. </P>
9C. CONSENT PROCEDURES:
>
><P>Every patient will be asked by the attending physician (or a designated
>physician extender) to sign a consent form prior to the application of
>the magnets. (A consent form is attached). </P>
>
><P>Inasmuch as all the patients coming to the Post Polio Clinic have good
>understanding of the English language, there is no need to provide a written
>translation of this informed consent to language other than English. </P>
>
10. RISK/BENEFIT RATIO:
>
><P>Since pain is one of the hallmarks of the post polio syndrome, any attempts
>to alleviate this pain could have a major impact on the management of this
>condition. </P>
>
><P>The pilot study will also pave the way for future studies to elucidate
>physiological mechanisms of action of low intensity magnetic fields on
>water and soft tissues. The reuslts could have far-reaching effects since
>they might apply to other conditions such as chronic arthritis, or other
>types of pain caused by a variety of conditions. </P>
>
10A. RISK/BENEFIT TO PATIENT:
>
><P>Since the risk is extremely low or non-existent and the benefits could
>be great, the risk/benefit ratio is very favorable. </P>
>
><P>11. This protocol conforms with OSHA/HHS Guidelines for HIV/HBV Occupational
>Safety. </P>
>
REFERENCES
>
><P>1. Becker, R.O., and Selden, G.: The Body Electric: Electromagnetism
>and the Foundation of Life: William Morrow & Company, Inc., New York,
>1985, p 364. </P>
>
><P>2. Becker, R.O., Cross Currents: Jeremy P. Tarcher/Perigee, Los Angeles,
>Ca 1990,p 336. </P>
><P>3. Davis, A.R., and Rawls, W.C.: Magnetism and its Effects on the Living
>System: Exposition Press; Hicksville, New York 1974, p 132, Chapter 10.
></P>
>
><P>4. Davis, A.R. and Rawls, W.C.: The Magnetic Effect: Exposition Press,
>Hicksville, New York, 1974., p 128. </P>
>
><P>5. Travell, J.G. and Simons, D.G.: Myofascial Pain and Dysfunction The
>Trigger Point Manual: Volume 1, The Upper Extremities, published in 1983
>and Volume 2, The Lower Extremities, published in 1992. Williams and Wilkins.
></P>
>
><P>6. Environmental Health Criteria 69: Magnetic Fields World Health
Organization,
>Geneva 1987, p 197. </P>
>
><P>7. Health and Safety Guide No. 27: Magnetic Fields Health and Safety
>Guide. World Health Organization. 1989, p 24. <BR>
>