Abstract:
A method of treatment of pain from inflammatory diseases such as arthritis is disclosed. The affected areas of the patient are shielded from high frequency electromagnetic radiation while permitting low frequency electromagnetic radiation to reach the affected areas. The method may be accomplished by applying a radiation-shielding textile for an extended period of time, either by fashioning a garment from the textile or using a sheet or cover, or fashioning a wrap. The radiation-shielding textile found to be suitable is a cloth woven of yarn consisting of a textile fibre, such as nylon, and from two to thirty-five percent by weight of electrically conductive filament, preferably stainless steel.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application is a continuation-in-part of U.S. patent application Ser. No. 10/445,007 filed May 27, 2003, which is pending. 
     
    
     TECHNICAL FIELD  
       [0002]     The present invention relates to methods of treating pain arising from inflammatory diseases in mammals such as humans. More particularly the invention relates to methods of treating pain arising from inflammatory diseases by shielding affected areas from high frequency electromagnetic fields.  
       BACKGROUND  
       [0003]     Arthritis and rheumatism are general terms for acute and chronic conditions which are widespread in the population whose common symptoms are pain caused by inflammation. Arthritis is characterized by inflammation of a joint, accompanied by pain and swelling. Rheumatism is a general category of conditions characterized by inflammation and pain in muscles and joints and includes arthritis. Forms of arthritis include osteoarthritis. rheumatoid arthritis, ankylosing spondylitis (AS) and systemic lupus erythematosus (SLE). Rheumatic conditions include infectious arthritis, rheumatoid arthritis, arthritis due to rheumatic fever, arthritis due to trauma or degenerative joint disease, myositis, neurogenic arthropathy, bursitis, fibromyositis and hydroarthrosis. The causes of such disease may be other degenerative diseases, trauma or auto-immune diseases such as SLE. What these diseases, referred to herein as inflammatory diseases, share in common is inflammation, causing pain. Treatment has typically focussed on pain-killing and anti-inflammatory drugs.  
         [0004]     Fibromyalgia is a widespread arthritic or rheumatic condition which is characterized by chronic pain in fibrous tissues such as muscles and connective tissues, fatigue, multiple tender points, abnormal sleep patterns, stiffness, headaches, irritable bowels numbness and other symptoms. It is also associated with chronic fatigue syndrome. The cause of fibromyalgia is unknown and there are no known cures. Various medications are used to treat fibromyalgia, as well as hypnosis, but there are no known medications which permanently relieve its symptoms.  
         [0005]     The inventor of the present invention has previously discovered that pain resulting from exposed or damaged nerve ends, commonly referred to as phantom limb pain, can be relieved or alleviated by shielding the painful area with a cloth woven from a yarn containing threads of a conductive metal. As disclosed in U.S. Pat. No. 4,653,473, the contents of which are incorporated herein by reference, which issued to the inventor on 31 Mar., 1987, the yarn of the cloth used in this previously-discovered method is preferably composed of from 2 to 35% by weight of conductive metal filament, and the balance of natural or synthetic textile fiber such as nylon. The metal may be any conductor, but a stainless steel alloy has been found to be effective.  
         [0006]     The inventor of the present invention has also discovered that a similar method can be used to relieve muscle pain and soreness and reduce nervousness in horses. This method of treating horse pain and nervousness comprises fashioning a horse blanket of a cloth woven from a yarn containing threads of conductive metal, and placing it on the horse. This method is disclosed in U.S. Pat. No. 4,825,877, the contents of which are incorporated herein by reference, which issued to the inventor of the present invention on 2 May, 1989. The inventor of the present invention has also discovered that a similar method can be used to alleviate delayed onset muscle soreness as disclosed in U.S. Pat. No. 6,146,351 issued 14 November, 2000, the contents of which are incorporated herein by reference. See also Zhang J., Clement D, and Taunton J. “The Efficacy of Farabloc, an Electromagnetic Shield, in Attenuating Delayed-Onset Muscle Soreness” Clin J. Sport Med, 2000 January;10(1):15-21. PMID:  106995845  [PubMed—indexed for MEDLINE].  
         [0007]     Up to now the reason for the efficacy of these methods has not been well understood, but was believed to arise from the shielding of electromagnetic fields. While it was suspected that the same method may be beneficial for other types of pain such as arthritic pain, a theoretical or experimental basis for such an application had not been established. However it has now been discovered that a similar method may be implemented successfully in the treatment of inflammatory diseases generally, including fibromyalgia in humans and other arthritic and rheumatoid diseases by shielding affected areas from high frequency electromagnetic radiation while not shielding the area from low frequency radiation.  
       SUMMARY OF INVENTION  
       [0008]     The present invention provides a method of treatment of symptoms of inflammatory diseases in a patient comprising shielding the affected areas of the patient from high frequency electromagnetic radiation for a period of time sufficient to reduce the symptoms while permitting low frequency electromagnetic radiation to reach the affected areas.  
         [0009]     The invention further provides a method of treatment of symptoms of inflammatory diseases in a patient comprising the steps of: (i) providing an article of clothing configured to substantially cover the affected areas of the patient with a cloth comprising between two and thirty-five percent by weight of a continuous system of electrically conductive fibres; and (ii) the patient wearing the article of clothing whereby the affected areas of the trunk of the body of the patient are substantially covered by the conductive cloth over a period of time sufficient to reduce the symptoms. 
     
    
     BRIEF DESCRIPTION OF DRAWINGS  
       [0010]     In drawings which illustrate embodiments of the invention:  
         [0011]      FIG. 1  illustrates a hospital gown made from a cloth according to the invention. 
     
    
     DESCRIPTION  
       [0012]     Recently there has been increasing interest in electrobiological effects in humans. The use of low frequency electromagnetic fields to promote bone repair is well established. (See Pilla, “Low-intensity electromagnetic and mechanical modulation of bone growth and repair: are they equivalent?” J Orthrop Asc 2002; 7(3): 420-8). Electroporation, the use of high frequency, high voltage pulsed electrostimulation of cellular tissue to increase the permeability of the cell membrane has become well established and is used to enhance chemotherapy drug delivery (Neumann et al. “Fundamentals of electroporative delivery of drugs and genes” Bioelectrochem Bioenerg 1999 February; 48(1): 3-16; Gehl “Electroporation:theory and methods, perspectives for drug delivery, gene therapy and research”, Acta Physiol Scand 2003 April; 177(4); 437-47). Recent studies suggest low frequency electromagnetic fields reduce permeability of cell membranes ((Bordiushkov et al. “Structural-Functional changes in lymphocytes and erythrocyte membranes after exposure to alternating magnetic field” Vpor Med Khim 2000 January-February; 46(1):72-80; Heida et al. “Investigating membrane breakdown of neuronal cells exposed to non-unoform electric fields by finite-element modelling and experiments” IEEE Trans Biomed Eng 2002 October; 49(10): 1195-203). Recent studies have also suggested that application of electromagnetic fields may be used to treat inflammatory diseases (Nindl et al. “Experiments showing that electromagnetic fields can be used to treat inflammatory diseases” Biomed Sci Instrum 2000; 36: 7-13). The present inventor has discovered that pain from inflammatory diseases is reduced by shielding affected areas from high frequency electromagnetic fields. It is believed that by blocking high frequency EMF, the same effect on cell membranes is achieved as if low frequency EMF is applied, namely reduced permeability of cell membranes which in turn reduces inflammation. For purposes of this application, “high frequency electromagnetic fields” means electromagnetic fields having a frequency greater than about 1 megahertz. “Low frequency electromagnetic fields” means electromagnetic fields having a frequency less than about 1 megahertz. This may be accomplished, for example, by clothing in a cover, gown or other form of apparel or wrapping with a sheet of textile where the textile is made from a radiation shielding textile.  
         [0013]     A suitable covering material for the practice of the method of the invention which both provides the appropriate electromagnetic shielding and the comfort of a standard non-metallic textile is a fabric sold under the trade-mark FARABLOC. High frequency electromagnetic fields greater than 1 MHz such as radio waves are completely blocked by double layers of the FARABLOC material. However low frequency EMF are not blocked. The yarn from which the textile is woven is preferably composed of approximately 13% by weight of stainless steel filaments but may be from 2% to 35% by weight of stainless steel filaments. The balance of the yarn is a synthetic nylon fiber such as nylon. The yarn has an electrical conductance of approximately 330 ohms per centimeter. The preferred fabric has a warp of 24.5 threads per centimeter and a woof of 24.5 threads per centimeter but fabrics of other characteristics, such as knitted fabrics also will be effective. The weight of the woven fabric is preferably approximately 180 grams per square meter. The preferred binding is L 1/1—that is, one thread up and one thread down. The fabric may be knitted as well as woven. Other conductive materials would also be suitable for the conductive fibers, such as copper, silver or ceramics. Other natural or synthetic non-conductive fibers would also be suitable to comprise the yarn. It would also be suitable to utilize cloth woven or knitted of alternate threads of conductive and textile fibers.  
         [0014]     At the basis of the present invention is the discovery that shielding areas of the body affected by inflammatory diseases from high frequency electromagnetic radiation while permitting low frequency electromagnetic radiation to reach the affected areas has beneficial results in the alleviation of pain.  
         [0015]     Specifically with respect to fibromyalgia, according to the method of the invention, the fibromyalgia sufferer wears, for example, a gown as designated by reference numeral  10  in  FIG. 1 . The longer the period during which the gown is worn, the better the results, but preferably the gown is worn at least while the patient is sleeping during the night. The gown  10  need not be constructed entirely of the conductive cloth, but the gown should have a large enough area of the conductive cloth  12  to substantially cover the affected areas of the trunk of the patient&#39;s body. While the method preferably uses a gown  10 , other forms of apparel such as a shirt and pants or jumpsuit may be used, or a sheet or wrap secured about the patient&#39;s body using hook and loop fasteners, for example.  
         [heading-0016]     Summary of the First Study  
         [0017]     In a first study carried out on 126 patients hospitalized for 20 days, a double blind placebo controlled study was conducted to assess the efficacy of a FARABLOC gown worn at night compared to a placebo gown in alleviating the symptoms of fibromyalgia. Exclusion criteria included recent trauma, secondary fibromyalgia and inappropriate blood parameters. Inclusion criteria focussed on the classic bilateral nine point tender positions of fibromyalgia, scaled from zero to four. All drugs were stopped but paracetamol was provided on demand. Physiotherapy was consistently provided to all patients. Of the 126 patients who took part in the study, 84 wore placebo gowns and 42 wore FARABLOC gowns. Variables of total tenderness of the 18 fibromyalgia points, overall pain using the visual analogue scale and total drug use were assessed on admission and on discharge after 20 days in hospital. The following are the results of the first study.  
                                                                             FARABLOC   PLACEBO                                        # of subjects   42   84           Age (years)   49.02   48.08           SEX           Female   35   72           Male   7   12                      
 
         [0018]     The difference in pain and tenderness on admission and discharge was as follows:  
                                           MEAN +/− SD   MEAN +/− SD                   TOTAL TENDERNESS               Admission   48.86 +/− 3.71   49.40 +/− 4.02       Discharge   38.21 +/− 6.17   46.87 +/− 3.43       Difference   10.64 +/− 5.69    2.54 +/− 3.40       TOTAL PAIN       Admission    7.41 +/− 0.49    7.41 +/− 0.52       Discharge    5.39 +/− 0.99**    6.83 +/− 0.59       Difference    2.03 +/− 0.99**    0.59 +/− 0.71       TOTAL DRUG USE   10.69 +/− 6.68**   26.12 +/− 9.37                 **P &lt; 0.001 - Paired t-test             
 
 There was a strong positive effect of Farabloc on total tenderness, total pain and drug use in the study of fibromyalgia patients during 20 days of hospitalization. 
 
 Summary of the Second Study 
 
         [0021]     In a second study carried out on 25 patients hospitalized for 21 days, a double blind crossover study was conducted to assess the efficacy of a FARABLOC gown compared to a placebo gown in alleviating the symptoms of fibromyalgia. Exclusion criteria included recent trauma, secondary fibromyalgia and inappropriate blood parameters. Inclusion criteria focussed on the classic bilateral nine point tender positions of fibromyalgia, scaled from zero to four. All drugs were stopped but paracetamol was provided on demand. Physiotherapy was consistently provided to all patients. All patients were provided with new gowns on admission and at midpoint of the 21 day hospital period. This created three distinct groups who switched gowns as described. Variables of total tenderness of the 18 fibromyalgia points, overall pain using the visual analogue scale and total drug use were assessed on admission, midpoint and on discharge. The data was analyzed from the midpoint to the discharge period by assessment of change in three variables. The following are the results of the second study.  
                                                                                                     GOWN ORDER   GOWN ORDER   GOWN ORDER           FARABLOC/   PLACEBO/   PLACEBO/           PLACEBO   PLACEBO   FARABLOC                # subjects                11   7   7                        CHANGE    −6.5 +/− 5.559**    −0.29 +/− 2.56      8.71 +/− 4.75**       IN       TENDER-       NESS       CHANGE   −13.27 +/− 11.40**    −4.43 +/− 5.80     16.00 +/− 8.35**       IN       PAIN       CHANGE   −18.00 +/− 5.27**   −16.00 +/− 5.10    −9.29 +/− 4.39**       IN       DRUG       USE                 **P &lt; 0.001 - Paired t-test             
 
 The study found that the changes in tenderness and pain were significantly non-zero in the negative direction for the group which switched from Farabloc to placebo and positive for the group that switched from placebo to Farabloc. This supports the hypothesis that Farabloc reduces tenderness and pain in fibromyalgia patients. 
 
         [0023]     Based on the recent findings regarding electrobiologic effects, it is believed that the beneficial results of the FARABLOC material arise from reducing inflammation in cells due to both blockage of high frequency EMF to prevent increased permeability of the cell membrane and permitting low frequency EMF to reach the cell membranes to decrease permeability of the cell membranes. Consequently the results of the present method would also be applicable in the same way to reduce pain resulting from other inflammatory diseases, in particular the following specific diseases. While for fibromyalgia the trunk of the patient is shielded with Farabloc, other diseases would involve the shielding of the affected areas.  
         [0024]     The other inflammatory diseases with respect to which pain is alleviated by this method are Achilles tendinitis, Adhesive capsulitis, Ankylosing spondylitis, Anserine bursitis, Avascular necrosis, Bicipital tendinitis, Bursitis, Calcaneal bursitis, Calcium pyrophosphate dihydrate (CPPD), crystal deposition disease, Carpal tunnel syndrome, Chondrocalcinosis, Chondromalacia patellae, Costostemal syndrome, Degenerative joint disease, Dupuytren&#39;s contracture, Epicondylitis, Exercise-induced compartment syndrome, Fibromyalgia, Freiberg&#39;s disease, Gout, Hypertrophic osteoarthropathy, Impingement syndrome, Myofascial pain syndrome, Neuropathic arthropathy, Olecranon bursitis, Osgood-Schlatter&#39;s disease, Osteoarthritis, Osteochondromatosis, Osteoporosis, Paget&#39;s disease of bone, Patellofemoral pain syndrome, Plantar fasciitis, Polyarteritis nodosa, Polymyositis, Popliteal cysts, Posterior tibial tendinitis, Prepatellar bursitis, Psoriatic arthritis, Raynaud&#39;s phenomenon, Reflex sympathetic dystrophy syndrome, Retrocalcaneal bursitis, Rheumatoid arthritis, Rotator cuff tendinitis, Sacroiliitis, Scheuermann&#39;s osteochondritis, Scleroderma, Seronegative arthritis, Shoulder-hand syndrome, Spinal stenosis, Spondylolysis, Systemic lupus erythematosus (SLE), Tarsal tunnel syndrome, Tennis elbow, Traumatic arthritis and Trochanteric bursitis.  
         [0025]     As will be apparent to those skilled in the art in the light of the foregoing disclosure, many alterations and modifications are possible in the practice of this invention without departing from the spirit or scope thereof. For example, while a woven cloth has been specified in the description of the preferred embodiment, it will be apparent to those skilled in the art that a non-woven cloth having a grid of conductive filaments will also operate effectively in the method of the invention while retaining the qualities of a normal fabric. It will also be apparent that many variations in the type of conductive thread or yarn and textile fibers used in the cloth and in the manner of weaving or knitting the cloth are possible in the practice of this invention without departing from the scope thereof. Accordingly, the scope of the invention is to be construed in accordance with the substance defined by the following claims.