CA2102759C - Electrical stimulation for treatment of osteoarthritis - Google Patents
Electrical stimulation for treatment of osteoarthritis Download PDFInfo
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- CA2102759C CA2102759C CA002102759A CA2102759A CA2102759C CA 2102759 C CA2102759 C CA 2102759C CA 002102759 A CA002102759 A CA 002102759A CA 2102759 A CA2102759 A CA 2102759A CA 2102759 C CA2102759 C CA 2102759C
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- 201000008482 osteoarthritis Diseases 0.000 title claims abstract description 23
- 230000000638 stimulation Effects 0.000 title description 20
- 208000002193 Pain Diseases 0.000 claims abstract description 21
- 230000036407 pain Effects 0.000 claims abstract description 19
- 230000002917 arthritic effect Effects 0.000 claims abstract description 9
- 206010023230 Joint stiffness Diseases 0.000 claims abstract description 8
- 210000001503 joint Anatomy 0.000 claims abstract description 6
- 208000024891 symptom Diseases 0.000 claims abstract description 6
- 230000001953 sensory effect Effects 0.000 claims description 9
- 208000018934 joint symptom Diseases 0.000 claims 5
- 238000007493 shaping process Methods 0.000 claims 5
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- 239000003814 drug Substances 0.000 description 11
- 229940079593 drug Drugs 0.000 description 11
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- 238000009826 distribution Methods 0.000 description 5
- 238000004458 analytical method Methods 0.000 description 4
- 230000003349 osteoarthritic effect Effects 0.000 description 4
- 230000035807 sensation Effects 0.000 description 4
- 206010067484 Adverse reaction Diseases 0.000 description 3
- 208000006820 Arthralgia Diseases 0.000 description 3
- 208000010201 Exanthema Diseases 0.000 description 3
- 208000003947 Knee Osteoarthritis Diseases 0.000 description 3
- 230000006838 adverse reaction Effects 0.000 description 3
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- 208000036487 Arthropathies Diseases 0.000 description 1
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- 229940124599 anti-inflammatory drug Drugs 0.000 description 1
- 210000001188 articular cartilage Anatomy 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- OJIJEKBXJYRIBZ-UHFFFAOYSA-N cadmium nickel Chemical compound [Ni].[Cd] OJIJEKBXJYRIBZ-UHFFFAOYSA-N 0.000 description 1
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- 210000000629 knee joint Anatomy 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Biophysics (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Pain & Pain Management (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Electrotherapy Devices (AREA)
Abstract
A method and apparatus for treating osteoarthritis symptoms including pain, joint stiffness, limitation of range of motion and limitation of overall function through the use of subsensory unidirectional voltage pulses in the frequency range of 90 to 110 hertz applied to non-invasive conductive electrodes in contact with a patient's skin proximal to an arthritic joint.
Description
ELEGTRIC.AL STIl~dilLelTIO~I FOR TlE%E~TIbIEIIIT
OF OSTEO~R.TI~RITIS
The invention relates to a method and apparatus for the treatment of osteoarthritis.
Osteoarthritis or osteoarthrosis is a degenerative joint disease which commonly affects both axial and peripheral diarthrodial joints in humans. Moreover, since 'the incidence of this disease increases steadily with age, it is an almost universal occurrence in the elderly.
pathological characteristics of osteoarthri.tis include progressive deterioration and loss of articular cartilage from the surfaces of joints, as well as reactive changes at 'the joint margins and the underlying bone. Manifestations of the disease that are treatable are joint pain, stiffness and limitation of motion. Synovitis or joint inflammation is also a common secondary manifestation of the disease th at is also treatable. Although, as aforementioned, high incidence, of the disease occurs in the elderly, the treatment is highly individualized and may inaludee (a) prescription of a pharmacological agewt, (b) a surgical procedure, or (c) a physical modality.
Conventionally, patients exhibiting symptomatic osteoar~thritis arm initially treated by their physician by the administration of a nonsteroidal Id anti-inflammatory drug (NSAID). As indicated by U.S. patents 4,997,850 issued to Kimura et al and 4,944,949 issued to Story et al, many such nonsteroidal anti-inflammatory drugs are known ,nrl are ~reqtiently effective in reducing the symptoms o.1' osteoarthritis. That is to say, they have demonstrated value in helping to relieve pain, improve activity levels, and in some cases improve function in osteoarthritic patients. Many members of this class of drugs have been approved by the U.S. Food and Drug Administration for the treatmetnt of osteoarthritis.
None of these drugs, however, have been proven in carefully controlled clinical trials to re~rersP
the long term natural history of this degenerat:.ive joint disease. Moreover, while many of these drugs have demonstrated effectiveness in treating the symptoms of osteoarthritis, they also have been associated with significant toxicities and other risks, such as deleterious effects on cartilage when used over prolonged periods of time. In March o.i:
1989, for example, the U.S. Food and Drug Administration moved to warn both doctors and the public about the use of, such drugs which were said to have become the No. 1 cause of complications among all prescription drugs. Moreover, in add9.t:i.on to being ~rery expensive the toxicit:ies of such drugs limit 'their usefulness, particularly in elderly patients.
In this regard, the above nested patent to Story et al recognizes that nonsteroidal anti-inflammatory drugs are the drugs of choice for various forms of inflammatory arthropathy including osteoarthritis, but that their prostaglandin inhibiting property responsible for their effectiveness may also be responsible for reducing the protective effects of prostaglandin on gastroiwtestinal mucosa. Story et al indicate that conventional enteric coatings applied over such drugs have not been fully effective and thereafter it is said that they have discovered that the use of micelles enables a particularly appropriate form of such nonsteroidal anti-inflammatory drugs to be achieved.
A second form of treating osteoarthritis involves surgery including non-replacement as well as joint replacement procedures. The latter procedures are usually offered only after non-operative as well as non-replacement surgical measures have been exhausted. Siach surgical procedures as currently used vary greatly as to complexity, cost, success rate and risk, and in many respects are not alternative therapies vis-a--~ri.s pharmacological agents and physical modalities.
The third major known form of treatment for osteoarthritis; namely, physical modalities, are useful in reducing pain and/or restoring function, particularly in patients for whom pharmacological agents have either been minimally effective or. have been poorly tolerated. Although this general form of treatment would include simple bed rest, traction and heat treatment, among other things, the most widely studied is that of modifying pain perception via electrical nerve stimulation using noninvasive transct~taneous electrical nerve stimulators (TANS).
lain modulation or control of pain by electrical stimulation is conventionally '\
~.~~~~~J~
accomplished in three ways; namely, (1) sensory level stimulation, (2) motor level stimulation, and (3) noxious-level stimulation. As to the first, which is the most widely recognized and studied, electrical stimulation is delivered at or above a level felt by the patient but below motor level threshold. Such sensory level stimulation is generally obtained with low level pulses in the frequency range of 50-100 hertz with pulse widths in the range of 2-50 microseconds. Such sensory level stimulation is for the purpose of stimulating or activating only the largest diameter superf~.cial nerve and is generally effective in the relief of acute pain problems.
Motor level stimulation, which by definition produces muscle contraction, is most often used clinically with chronic pain patients. Such motor level stimulation is generally accomplished in a frequency range of 2-~ hertz with pulse widti~s greater than 150 microseconds and intensities lzigh enough to produce a strong visible muscle contraction.
Noxious level stimulation will produce a painful stimulus at the pain site or a site remote from the pain site and is generally accomplished in the frequency range of 1-5 hertz or greater tl~».n 100 hertz with long pulse durations of up to 1 second and at intensities which produce painful sensory stimulation with or without muscle contraction.
Such stimulation may cause a quick onset of pain relief identified as "hyperstimulation analgesia".
Substantially all commercially available transcutaneous electrical nerve stimulators (TENS) ~:~fl~''~~fl can produce stimulation at each of 'the aforementioned levels, and several are mar)ceted with instructions for using the device at each of the noted levels by way of adjustment of current, voltage or other delivery characteristics.
Exemplary prior art transcutaneous electrical nerve stimulators may be found in IT.S. Patent No.
3,$$1,494 to Paul et al and 3,9012,502 to Liss. The Paul et al device is said to be provide temporary pain relj.ef to arthritic patients when the level of current used in the treatment is the maximum level the patient can comfortably endure. Liss, on the other hand, discloses a device for producing a one-way low current at a frequency of 20 kilocycles to 1 megacycle with an on duty cycle of 75%
modulated at 1C)-40 hertz. It is said that the apparatus with the electrodes properly positioned along nerves provides a nerve stimulator, which, although battery powered, employs a small current that often requires a viewing of the meter to be sure that treatment is in process. A manual control is provided whereby the patient may reduce the input to tolerable levels until repeated use builds up a conditioning acceptance, It is additionally indicated that the current flow is applied to give a pumping action to the nerve train between the applied contact points, and the impedance of the patient is compensated by the constant current circuit which is automatically readjusted to the needs of the patient.
Most commercially available transcutaneous electrical nerve stimulators are current sourced and have a common goal in addition to pain relief of comfortable treatment so as to reduce apprehension as to the electrical aspect of the treatment.
Conventionally, the patient using such devices is instructed to slowly advance the amplitude control until the electrical stimulation is felt with subsequent higher settings used as the patient becomes accustomed to the stimulation. As demonstrated by such devices, electrical stimti).ation employed in the ~orm of transcutaneous electrical nerve stimulators is a potentially important physical modality for the treatment of pain in a broad variety of medical problems. Although a number of such devices have indications pertaining 'to effective pain treatment under the broad term of arthritis and a few include osteoarthritic pain, such prior devices have not been carefully clinically studied or consistently employed to directly treat still other important aspects of osteoarthritis, such as joint stiffness, range of motion and function.
Accordingly, it is the primary object of the present invention to employ a method and apparatus having demonstrated statistically significant improvement for all of the primary clinical mPasurA~
of osteoarthritis. Such measures include independent clinical measures of joint stiffness, range of motion and overall function in addition to reduction in pain. More specifically, I have discovered a method and apparatus for the treatment of the broader aspects that define osteoarthritis by using electrical Stimulation at a subsensory level whereby the amplitude of the voltage source signal is first adjusted to pravide a slight sensation to s' - ~) ~' C' ~~~~, le) the patient and thereafter immediately reduced to a subsensory level for the duration of the treatment.
Such treatment has been clinically shown in carefully cowtrolied double-blinded trials to reduce osteoarthritis joint pain, improve the range of joint motion, reduce morning stiffness and improve joint function as judged by the patient, as well as a physicians global evaluation in five medical centers.
These, as well as other objects and advantages of this invention will be more clearly appreciated by carefully studying the following detailed description of a presently preferred exemplary embodiment of this invention in conjunction with the accompanying drawings in which:
FIGURE 1 is a block diagram of an exemplary electrical stimulator apparatus;
FIGURE 2 is a more detailed schematic diagram of a presently preferred embodiment of my electrical stimulator apparatus;
FIGURE 3 is a voltage waveform illustrating the characteristics of the electrical treatment signal under no load condition as produced by the electrical stimulator apparatus; and FIGURE ~ illustrates two examples of electrode placement in the treatment of osteoarthritic joints.
g As may be seen from a consideration of the block diagram of FIGURE 1 illustrating 'the electrical stimulator apparatus for implementing my methad of treating osteoarthritis, the stimulator includes a relaxation oscillator 1 with 'the output thereof differentiated at 2 so as to produce spilced negative going R-C time constant type pulses of the nature illustrated in FIGURE ~. Such voltage pulses repeat within the frequency range of 90-110 hertz.
Such differentiated output voltage pulses are connected to an attenuator for varying the outpr~t level of such pulses from zero to the maximtam battery voltage minus approximately 2 volts. Tlzat is to say, the use of a 12 volt battery will allow the production of a maximum amplitude pulses of approximately -ZO volts. The output of the attenuator in turn is buffered by a unity gain push-pull transistor output stage 4, which in t~.~rn is coupled to the output leads by a large capacitor and a DG restorer circuit 6. The capacitive output stage is designed so as to prevent the application of full battery voltage on the output leads in the event that the oscillator or amplifier section should fail. Additionally, as may be Seen from FIGURE L, the electrical stimulator is powered by batterjr 7 by way of power switch 8.
As implemented for clinical testing, the elements of FIGURE 1 include the components as detailed in FIGURE 2. For example, the relaxation oscillator may include a conventional integrated circuit 10 for generating a pulsed output which is shaped by the associated capacitors, resistors and diode of differentiator 12. The amplitude of the differentiated voltage output pulses are adjusted by way of the variable setting of potentiometer R6 with the output of the attenuator buffered by way of the unit gain transistor output stage comprising 91 and Q2 followed by a capacitive output stage. The stimulator unit is powered by an internal 12 volt nickel-cadmium battery pack 17 by way of power switch SW-1.
As may be seen from FTGURE 2, the battery pack may be charged by an external transformer (not shown) which is connected by way of the charger jack 19. The presence of a charging voltage is indicated through the use of a yellow LED 20. Moreover, the unit may be tested for an output voltage by momentarily closing test switch SW-2 which will activate a red LED 21 in the presence of an otttput voltage. Additionally, a complete circuit path through a patient is indicated by way of a green I,FD
22. When the electrical stimulator is turned on and a patient is connected to electrodes that are normally attached to output jacks J1 and J2, LF;D 22 is connected to the output jacks by way of the series connected input winding of transformer T).
with the secondary winding connected to an amplifier.
stage comprising transistors Q3 and Q4.
The stimulator circuit shown in FIGUF2E 2 is illustrative of two types of such stimulators identified as "active" and °'inactive" as used in the carefully controlled double--blinded clinical trials. '.Chat is to say, as used in the clinical study both types of stimulators were essentially the same except that the "active" patients were connected to the stimulator by way of output jacks Jl and J2 and the "inactive" patients were connected to the stimulator by jacks J1 and J3. Both units contained the switch SW-3 that was used by the patient during the set up period. During the clinical studies patients were instructed to turn the stimulator on and to depress switch SW-~ while turning the output to a level that was felt by the individual patient. Thereafter, the patient was instructed 'to slowly reduce the output level to one which was not felt at which point the switch SW-was to be released. The patient was additionaal.y told that there should be no change in sensation when the switch was pressed and released and that iE
a change was felt the stimulator should be further reduced so that no change in sensation was detected for either position of the switch.
As may be seen from FIGURF 2, patients using the "inactive°' stimulators with electrodes attached to output jacks J1 and J3 would not receive any electrical signal after switch SW-3 was released.
Whereas, patients using "active" stimulators received an electrical signal at a subsensory level when SW-3 was released since for "active" patients the electrodes were connected to output jacks J1 a..nd J2. Thus, the design allowed for a "placebo"
treatment o~ patients with "inactive'" stimulators, as well as an active treatment of patients with °'active" stimulators. Moreover, the placebo devices physically looked and functioned like the active devices including the production of the stimulator output during the set up period. Thereafter, however, when SW-3 was released at the end of the set up process, no electrical stimulation was produced at the electrode outputs of inactive devices. Accordingly, each placebo control patiAnt wore a device which provided no electrical stimulation during the treatment time.
Prior to the above noted clinical trials in humans, a confidential Premarket Approval Application was filed with the U.S. Food and Drug Administration summarizing research on animal models wherein the research had clear implications for the treatment of arthritis in humans. The application and research results presented indicated that the stimulator device used was both safe for anima.l.s and had the potential to treat injuries and diseases involving cartilage damage such as osteoarthritis.
These studies combined with previous work of others using different electrical signals resulted in an approved FDA Investigational Device Exemption which permitted the conduct of human clinical studies o.~
osteoarthritis and rheumatoid arthritis using th a disclosed simulator system.
Thereafter, clinical investigation of the disclosed system was carried Ou t in five medir.al centers using both active and placebo devices wl~.irh were visually indistinguishable from one anotliPr.
Moreover, the investigation was conducted using the double-blind technique wherein neither the patients nor the physicians were aware of which units were active or placebo devices, and the devices were randomly distributed. Within each sequence of ten devices there are five active and five placebo. The ten devices were given to patients on a randomized ~~ ~''~ ~~
basis, and neither the patient nor the physiciarv was made aware of which devices were active.
Patients with osteoarthritis in at least onP
knee were qualified by their treating physician using criteria whereby 'the patient was required to be over twenty years of age with degenerative joint disease supported by radiographic and clinical evidence of same. Moreover, patients were expected to maintain their current medication throughout the study interval. The study interval was eight weeks in length with the first two weeks used for pretreatment base line observations. Thereafter, the device (active or placebo) was to be used daily for the next four weeks with a two week post-treatment follow-up interval for the detection and observation of adverse reactions if any.
Treatment consisted of a portable battery operated device with non-invasive electrodes applier~
to the designated knee daily for four weeks.
Placement of the electrodes for the knee was as shown in one of the two examples illustrated in FIGURE 4 wherein the negative electrode (C) was placed over the osteoarthritic knee joint with the positive electrode "A" placed on the same limb proximal to the negative electrode.
Patients were instructed in the proper use of the device as described above and were told to use the devices for six to ten hours per day. The devices were generally worn during the night whale the patient was asleep. As previously noted, the placebo device looked arid seemingly functioned like the active device including the production of the sensation for setting the stimulation level for each instance of use.
The five medical centers summarized in this study provided data for 41 patients in the active group and 37 patients in the placebo group.
Evaluable patient counts are: active device 38 patients and placebo device 33 patients. Two patients on the active device and four patients on the placebo device dropped out early in the treatment phase of the study. One additioIlal patient on the active device cornpleted the study with favorable results, however, this patient did not have a matching placebo control in this data set and was not included in the analysis.
There were three primary efficacy criteria reported on standardized ten centimeter visual analog scales marked with numbers 0 to 10 to indicate scores of increasing numerical severity.
These criteria are: physician overall evaltaati.on, patient evaluation of function of the treated l:nea and patient evaluation of pain in the treated knee.
These efficacy criteria were expressed as scores and as percent change from baseline. Statistically significant differences for all primary efficacy criteria favored the disclosed stimulator therapy in the three and four week treatment data.
percent change from baseline data were expanded to present frequency distributions showing counts of patients who experienced ranked categories of percent changes for each primary efficacy criterion.
Changes of 50 percent or greater were defined as marked clinical improvement. These qualitative data were combined to develop new frequency distributions ..\
1~ ~~~~~~~5~
showing counts of patients with 3, 2, 1 or 0 criteria with a change of 50 percent or greater.
One objective was to provide a single predictive index far physicians. For the active device, one-half of the patients experienced marked cl.inicaL
improvement in at least one primary efficacy criterion compared to only one-third in the placebo device group. Approximately one-fourth of the active device treated patients experienced marked clinical improvement in all three primary affica~y criteria compared to only sax percent in the placebo device group. The comparison between the active and placebo device frequency distributions was statistically significant (P <0.05).
This study also included average responses for several secondary efficacy criteria. The treating physicians evaluated tenderness, swelling, circumference, range of motion, extension and walking time. Tenderness and swelling did not provide discrimination between groups.
Circumference of the 'treated knee, however, imprnvpd with a mean decrease of -0.30 inches in the active device treated group in contrast to the placebo device treated group that worsened with a mean increase of + 0.13 inches. Walking time was not significantly different between groups and wm~l.cl not be expected to be so because the study treated only one knee and walking time is a function of both knees and hips. The range of knee motion as measured by flexion, showed an improvement for patients treated with the active device compared to the placebo device patients. A frequency distribution analysis of knee flexion showed degrees 15 ~~~~ f of improvement that were statistically significant in favor of 'the active device treated patients. n11 three secondary efficacy criteria evaluated by the patient s, (general morning stiffness, stiffne,s of_ the treated knee and overall symptoms) showed trends favoring the active device. The analysis of morning stiffness in minutes showed a mean improvement of 20 minutes in the active device treated patients compared to a one minute increase in morning stiffness in the placebo device patients. Moreover, results for the duration of morning stiffness in the treated knee were expanded to show frequency distributions for three ranked time intervals that support a statistically significant (P< 0.05) active versus placebo comparison.
Approximately equal percentages of patients on active and placebo devices (20%) reported experiencing a transient and m~.ld skin rash at thA
electrode location. The skin rash reported hPOP i.s comparable to that reported by other FDA appr.ov~~i electrical stimulators for non-union fracture.~, ,°W
for scoloisis. The rash prompted one active caevice patient and one placebo device patient to discontinue their study participation . One pat.i.ent on an active device reported a single episode o.f diarrhea. There were no new adverse reaction., reported in the two week follow-up iwterval after treatment.
Three of the medical centers treated private practice patients, and the two veterans° medical centers treated veterans only. All of the efficacy data analyses were carried out for the full data set 16 ~~_~r~~~~~
(five centers) and mast were carried out for the private practice patients (3 centers).
In summary, the two basic objectives o.f thi.s clinical investigation were clearly met. The disclosed method and apparatus can decrease pain anti improve joint function in patients with osteoarthritis of the knee. This is supported by statistical and clinically meaningful improvement in the efficacy criterion that measured change in the most widely recognized clinical features of joint pain, stiffness and limitation of motion. In addition, the adverse reactions that were reported during the clinical investigation were transient and resolved spontaneously following diagnosis and correction of the underlying cause or immediately following completion of treatment. All of these findings are the result of this five-center double blinded, randomized, clinical investigation that utilized a concurrent placebo device control.
The analysis of this carefully controlled clinical investigation provides valid scientific evidence that the disclosed method and stimulator are safe and effective for use in treating patients with osteoarthritis of the knee. More specifically, this device is indicated for use in relieving pain and improving function in patients with osteoarthritis of the knee.
While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, :it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.
OF OSTEO~R.TI~RITIS
The invention relates to a method and apparatus for the treatment of osteoarthritis.
Osteoarthritis or osteoarthrosis is a degenerative joint disease which commonly affects both axial and peripheral diarthrodial joints in humans. Moreover, since 'the incidence of this disease increases steadily with age, it is an almost universal occurrence in the elderly.
pathological characteristics of osteoarthri.tis include progressive deterioration and loss of articular cartilage from the surfaces of joints, as well as reactive changes at 'the joint margins and the underlying bone. Manifestations of the disease that are treatable are joint pain, stiffness and limitation of motion. Synovitis or joint inflammation is also a common secondary manifestation of the disease th at is also treatable. Although, as aforementioned, high incidence, of the disease occurs in the elderly, the treatment is highly individualized and may inaludee (a) prescription of a pharmacological agewt, (b) a surgical procedure, or (c) a physical modality.
Conventionally, patients exhibiting symptomatic osteoar~thritis arm initially treated by their physician by the administration of a nonsteroidal Id anti-inflammatory drug (NSAID). As indicated by U.S. patents 4,997,850 issued to Kimura et al and 4,944,949 issued to Story et al, many such nonsteroidal anti-inflammatory drugs are known ,nrl are ~reqtiently effective in reducing the symptoms o.1' osteoarthritis. That is to say, they have demonstrated value in helping to relieve pain, improve activity levels, and in some cases improve function in osteoarthritic patients. Many members of this class of drugs have been approved by the U.S. Food and Drug Administration for the treatmetnt of osteoarthritis.
None of these drugs, however, have been proven in carefully controlled clinical trials to re~rersP
the long term natural history of this degenerat:.ive joint disease. Moreover, while many of these drugs have demonstrated effectiveness in treating the symptoms of osteoarthritis, they also have been associated with significant toxicities and other risks, such as deleterious effects on cartilage when used over prolonged periods of time. In March o.i:
1989, for example, the U.S. Food and Drug Administration moved to warn both doctors and the public about the use of, such drugs which were said to have become the No. 1 cause of complications among all prescription drugs. Moreover, in add9.t:i.on to being ~rery expensive the toxicit:ies of such drugs limit 'their usefulness, particularly in elderly patients.
In this regard, the above nested patent to Story et al recognizes that nonsteroidal anti-inflammatory drugs are the drugs of choice for various forms of inflammatory arthropathy including osteoarthritis, but that their prostaglandin inhibiting property responsible for their effectiveness may also be responsible for reducing the protective effects of prostaglandin on gastroiwtestinal mucosa. Story et al indicate that conventional enteric coatings applied over such drugs have not been fully effective and thereafter it is said that they have discovered that the use of micelles enables a particularly appropriate form of such nonsteroidal anti-inflammatory drugs to be achieved.
A second form of treating osteoarthritis involves surgery including non-replacement as well as joint replacement procedures. The latter procedures are usually offered only after non-operative as well as non-replacement surgical measures have been exhausted. Siach surgical procedures as currently used vary greatly as to complexity, cost, success rate and risk, and in many respects are not alternative therapies vis-a--~ri.s pharmacological agents and physical modalities.
The third major known form of treatment for osteoarthritis; namely, physical modalities, are useful in reducing pain and/or restoring function, particularly in patients for whom pharmacological agents have either been minimally effective or. have been poorly tolerated. Although this general form of treatment would include simple bed rest, traction and heat treatment, among other things, the most widely studied is that of modifying pain perception via electrical nerve stimulation using noninvasive transct~taneous electrical nerve stimulators (TANS).
lain modulation or control of pain by electrical stimulation is conventionally '\
~.~~~~~J~
accomplished in three ways; namely, (1) sensory level stimulation, (2) motor level stimulation, and (3) noxious-level stimulation. As to the first, which is the most widely recognized and studied, electrical stimulation is delivered at or above a level felt by the patient but below motor level threshold. Such sensory level stimulation is generally obtained with low level pulses in the frequency range of 50-100 hertz with pulse widths in the range of 2-50 microseconds. Such sensory level stimulation is for the purpose of stimulating or activating only the largest diameter superf~.cial nerve and is generally effective in the relief of acute pain problems.
Motor level stimulation, which by definition produces muscle contraction, is most often used clinically with chronic pain patients. Such motor level stimulation is generally accomplished in a frequency range of 2-~ hertz with pulse widti~s greater than 150 microseconds and intensities lzigh enough to produce a strong visible muscle contraction.
Noxious level stimulation will produce a painful stimulus at the pain site or a site remote from the pain site and is generally accomplished in the frequency range of 1-5 hertz or greater tl~».n 100 hertz with long pulse durations of up to 1 second and at intensities which produce painful sensory stimulation with or without muscle contraction.
Such stimulation may cause a quick onset of pain relief identified as "hyperstimulation analgesia".
Substantially all commercially available transcutaneous electrical nerve stimulators (TENS) ~:~fl~''~~fl can produce stimulation at each of 'the aforementioned levels, and several are mar)ceted with instructions for using the device at each of the noted levels by way of adjustment of current, voltage or other delivery characteristics.
Exemplary prior art transcutaneous electrical nerve stimulators may be found in IT.S. Patent No.
3,$$1,494 to Paul et al and 3,9012,502 to Liss. The Paul et al device is said to be provide temporary pain relj.ef to arthritic patients when the level of current used in the treatment is the maximum level the patient can comfortably endure. Liss, on the other hand, discloses a device for producing a one-way low current at a frequency of 20 kilocycles to 1 megacycle with an on duty cycle of 75%
modulated at 1C)-40 hertz. It is said that the apparatus with the electrodes properly positioned along nerves provides a nerve stimulator, which, although battery powered, employs a small current that often requires a viewing of the meter to be sure that treatment is in process. A manual control is provided whereby the patient may reduce the input to tolerable levels until repeated use builds up a conditioning acceptance, It is additionally indicated that the current flow is applied to give a pumping action to the nerve train between the applied contact points, and the impedance of the patient is compensated by the constant current circuit which is automatically readjusted to the needs of the patient.
Most commercially available transcutaneous electrical nerve stimulators are current sourced and have a common goal in addition to pain relief of comfortable treatment so as to reduce apprehension as to the electrical aspect of the treatment.
Conventionally, the patient using such devices is instructed to slowly advance the amplitude control until the electrical stimulation is felt with subsequent higher settings used as the patient becomes accustomed to the stimulation. As demonstrated by such devices, electrical stimti).ation employed in the ~orm of transcutaneous electrical nerve stimulators is a potentially important physical modality for the treatment of pain in a broad variety of medical problems. Although a number of such devices have indications pertaining 'to effective pain treatment under the broad term of arthritis and a few include osteoarthritic pain, such prior devices have not been carefully clinically studied or consistently employed to directly treat still other important aspects of osteoarthritis, such as joint stiffness, range of motion and function.
Accordingly, it is the primary object of the present invention to employ a method and apparatus having demonstrated statistically significant improvement for all of the primary clinical mPasurA~
of osteoarthritis. Such measures include independent clinical measures of joint stiffness, range of motion and overall function in addition to reduction in pain. More specifically, I have discovered a method and apparatus for the treatment of the broader aspects that define osteoarthritis by using electrical Stimulation at a subsensory level whereby the amplitude of the voltage source signal is first adjusted to pravide a slight sensation to s' - ~) ~' C' ~~~~, le) the patient and thereafter immediately reduced to a subsensory level for the duration of the treatment.
Such treatment has been clinically shown in carefully cowtrolied double-blinded trials to reduce osteoarthritis joint pain, improve the range of joint motion, reduce morning stiffness and improve joint function as judged by the patient, as well as a physicians global evaluation in five medical centers.
These, as well as other objects and advantages of this invention will be more clearly appreciated by carefully studying the following detailed description of a presently preferred exemplary embodiment of this invention in conjunction with the accompanying drawings in which:
FIGURE 1 is a block diagram of an exemplary electrical stimulator apparatus;
FIGURE 2 is a more detailed schematic diagram of a presently preferred embodiment of my electrical stimulator apparatus;
FIGURE 3 is a voltage waveform illustrating the characteristics of the electrical treatment signal under no load condition as produced by the electrical stimulator apparatus; and FIGURE ~ illustrates two examples of electrode placement in the treatment of osteoarthritic joints.
g As may be seen from a consideration of the block diagram of FIGURE 1 illustrating 'the electrical stimulator apparatus for implementing my methad of treating osteoarthritis, the stimulator includes a relaxation oscillator 1 with 'the output thereof differentiated at 2 so as to produce spilced negative going R-C time constant type pulses of the nature illustrated in FIGURE ~. Such voltage pulses repeat within the frequency range of 90-110 hertz.
Such differentiated output voltage pulses are connected to an attenuator for varying the outpr~t level of such pulses from zero to the maximtam battery voltage minus approximately 2 volts. Tlzat is to say, the use of a 12 volt battery will allow the production of a maximum amplitude pulses of approximately -ZO volts. The output of the attenuator in turn is buffered by a unity gain push-pull transistor output stage 4, which in t~.~rn is coupled to the output leads by a large capacitor and a DG restorer circuit 6. The capacitive output stage is designed so as to prevent the application of full battery voltage on the output leads in the event that the oscillator or amplifier section should fail. Additionally, as may be Seen from FIGURE L, the electrical stimulator is powered by batterjr 7 by way of power switch 8.
As implemented for clinical testing, the elements of FIGURE 1 include the components as detailed in FIGURE 2. For example, the relaxation oscillator may include a conventional integrated circuit 10 for generating a pulsed output which is shaped by the associated capacitors, resistors and diode of differentiator 12. The amplitude of the differentiated voltage output pulses are adjusted by way of the variable setting of potentiometer R6 with the output of the attenuator buffered by way of the unit gain transistor output stage comprising 91 and Q2 followed by a capacitive output stage. The stimulator unit is powered by an internal 12 volt nickel-cadmium battery pack 17 by way of power switch SW-1.
As may be seen from FTGURE 2, the battery pack may be charged by an external transformer (not shown) which is connected by way of the charger jack 19. The presence of a charging voltage is indicated through the use of a yellow LED 20. Moreover, the unit may be tested for an output voltage by momentarily closing test switch SW-2 which will activate a red LED 21 in the presence of an otttput voltage. Additionally, a complete circuit path through a patient is indicated by way of a green I,FD
22. When the electrical stimulator is turned on and a patient is connected to electrodes that are normally attached to output jacks J1 and J2, LF;D 22 is connected to the output jacks by way of the series connected input winding of transformer T).
with the secondary winding connected to an amplifier.
stage comprising transistors Q3 and Q4.
The stimulator circuit shown in FIGUF2E 2 is illustrative of two types of such stimulators identified as "active" and °'inactive" as used in the carefully controlled double--blinded clinical trials. '.Chat is to say, as used in the clinical study both types of stimulators were essentially the same except that the "active" patients were connected to the stimulator by way of output jacks Jl and J2 and the "inactive" patients were connected to the stimulator by jacks J1 and J3. Both units contained the switch SW-3 that was used by the patient during the set up period. During the clinical studies patients were instructed to turn the stimulator on and to depress switch SW-~ while turning the output to a level that was felt by the individual patient. Thereafter, the patient was instructed 'to slowly reduce the output level to one which was not felt at which point the switch SW-was to be released. The patient was additionaal.y told that there should be no change in sensation when the switch was pressed and released and that iE
a change was felt the stimulator should be further reduced so that no change in sensation was detected for either position of the switch.
As may be seen from FIGURF 2, patients using the "inactive°' stimulators with electrodes attached to output jacks J1 and J3 would not receive any electrical signal after switch SW-3 was released.
Whereas, patients using "active" stimulators received an electrical signal at a subsensory level when SW-3 was released since for "active" patients the electrodes were connected to output jacks J1 a..nd J2. Thus, the design allowed for a "placebo"
treatment o~ patients with "inactive'" stimulators, as well as an active treatment of patients with °'active" stimulators. Moreover, the placebo devices physically looked and functioned like the active devices including the production of the stimulator output during the set up period. Thereafter, however, when SW-3 was released at the end of the set up process, no electrical stimulation was produced at the electrode outputs of inactive devices. Accordingly, each placebo control patiAnt wore a device which provided no electrical stimulation during the treatment time.
Prior to the above noted clinical trials in humans, a confidential Premarket Approval Application was filed with the U.S. Food and Drug Administration summarizing research on animal models wherein the research had clear implications for the treatment of arthritis in humans. The application and research results presented indicated that the stimulator device used was both safe for anima.l.s and had the potential to treat injuries and diseases involving cartilage damage such as osteoarthritis.
These studies combined with previous work of others using different electrical signals resulted in an approved FDA Investigational Device Exemption which permitted the conduct of human clinical studies o.~
osteoarthritis and rheumatoid arthritis using th a disclosed simulator system.
Thereafter, clinical investigation of the disclosed system was carried Ou t in five medir.al centers using both active and placebo devices wl~.irh were visually indistinguishable from one anotliPr.
Moreover, the investigation was conducted using the double-blind technique wherein neither the patients nor the physicians were aware of which units were active or placebo devices, and the devices were randomly distributed. Within each sequence of ten devices there are five active and five placebo. The ten devices were given to patients on a randomized ~~ ~''~ ~~
basis, and neither the patient nor the physiciarv was made aware of which devices were active.
Patients with osteoarthritis in at least onP
knee were qualified by their treating physician using criteria whereby 'the patient was required to be over twenty years of age with degenerative joint disease supported by radiographic and clinical evidence of same. Moreover, patients were expected to maintain their current medication throughout the study interval. The study interval was eight weeks in length with the first two weeks used for pretreatment base line observations. Thereafter, the device (active or placebo) was to be used daily for the next four weeks with a two week post-treatment follow-up interval for the detection and observation of adverse reactions if any.
Treatment consisted of a portable battery operated device with non-invasive electrodes applier~
to the designated knee daily for four weeks.
Placement of the electrodes for the knee was as shown in one of the two examples illustrated in FIGURE 4 wherein the negative electrode (C) was placed over the osteoarthritic knee joint with the positive electrode "A" placed on the same limb proximal to the negative electrode.
Patients were instructed in the proper use of the device as described above and were told to use the devices for six to ten hours per day. The devices were generally worn during the night whale the patient was asleep. As previously noted, the placebo device looked arid seemingly functioned like the active device including the production of the sensation for setting the stimulation level for each instance of use.
The five medical centers summarized in this study provided data for 41 patients in the active group and 37 patients in the placebo group.
Evaluable patient counts are: active device 38 patients and placebo device 33 patients. Two patients on the active device and four patients on the placebo device dropped out early in the treatment phase of the study. One additioIlal patient on the active device cornpleted the study with favorable results, however, this patient did not have a matching placebo control in this data set and was not included in the analysis.
There were three primary efficacy criteria reported on standardized ten centimeter visual analog scales marked with numbers 0 to 10 to indicate scores of increasing numerical severity.
These criteria are: physician overall evaltaati.on, patient evaluation of function of the treated l:nea and patient evaluation of pain in the treated knee.
These efficacy criteria were expressed as scores and as percent change from baseline. Statistically significant differences for all primary efficacy criteria favored the disclosed stimulator therapy in the three and four week treatment data.
percent change from baseline data were expanded to present frequency distributions showing counts of patients who experienced ranked categories of percent changes for each primary efficacy criterion.
Changes of 50 percent or greater were defined as marked clinical improvement. These qualitative data were combined to develop new frequency distributions ..\
1~ ~~~~~~~5~
showing counts of patients with 3, 2, 1 or 0 criteria with a change of 50 percent or greater.
One objective was to provide a single predictive index far physicians. For the active device, one-half of the patients experienced marked cl.inicaL
improvement in at least one primary efficacy criterion compared to only one-third in the placebo device group. Approximately one-fourth of the active device treated patients experienced marked clinical improvement in all three primary affica~y criteria compared to only sax percent in the placebo device group. The comparison between the active and placebo device frequency distributions was statistically significant (P <0.05).
This study also included average responses for several secondary efficacy criteria. The treating physicians evaluated tenderness, swelling, circumference, range of motion, extension and walking time. Tenderness and swelling did not provide discrimination between groups.
Circumference of the 'treated knee, however, imprnvpd with a mean decrease of -0.30 inches in the active device treated group in contrast to the placebo device treated group that worsened with a mean increase of + 0.13 inches. Walking time was not significantly different between groups and wm~l.cl not be expected to be so because the study treated only one knee and walking time is a function of both knees and hips. The range of knee motion as measured by flexion, showed an improvement for patients treated with the active device compared to the placebo device patients. A frequency distribution analysis of knee flexion showed degrees 15 ~~~~ f of improvement that were statistically significant in favor of 'the active device treated patients. n11 three secondary efficacy criteria evaluated by the patient s, (general morning stiffness, stiffne,s of_ the treated knee and overall symptoms) showed trends favoring the active device. The analysis of morning stiffness in minutes showed a mean improvement of 20 minutes in the active device treated patients compared to a one minute increase in morning stiffness in the placebo device patients. Moreover, results for the duration of morning stiffness in the treated knee were expanded to show frequency distributions for three ranked time intervals that support a statistically significant (P< 0.05) active versus placebo comparison.
Approximately equal percentages of patients on active and placebo devices (20%) reported experiencing a transient and m~.ld skin rash at thA
electrode location. The skin rash reported hPOP i.s comparable to that reported by other FDA appr.ov~~i electrical stimulators for non-union fracture.~, ,°W
for scoloisis. The rash prompted one active caevice patient and one placebo device patient to discontinue their study participation . One pat.i.ent on an active device reported a single episode o.f diarrhea. There were no new adverse reaction., reported in the two week follow-up iwterval after treatment.
Three of the medical centers treated private practice patients, and the two veterans° medical centers treated veterans only. All of the efficacy data analyses were carried out for the full data set 16 ~~_~r~~~~~
(five centers) and mast were carried out for the private practice patients (3 centers).
In summary, the two basic objectives o.f thi.s clinical investigation were clearly met. The disclosed method and apparatus can decrease pain anti improve joint function in patients with osteoarthritis of the knee. This is supported by statistical and clinically meaningful improvement in the efficacy criterion that measured change in the most widely recognized clinical features of joint pain, stiffness and limitation of motion. In addition, the adverse reactions that were reported during the clinical investigation were transient and resolved spontaneously following diagnosis and correction of the underlying cause or immediately following completion of treatment. All of these findings are the result of this five-center double blinded, randomized, clinical investigation that utilized a concurrent placebo device control.
The analysis of this carefully controlled clinical investigation provides valid scientific evidence that the disclosed method and stimulator are safe and effective for use in treating patients with osteoarthritis of the knee. More specifically, this device is indicated for use in relieving pain and improving function in patients with osteoarthritis of the knee.
While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, :it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.
Claims (16)
1. An apparatus for treating arthritic joint symptoms, said apparatus comprising:
non-invasive conductive electrode means for contacting a patient's skin proximate said joint;
pulse generating means connected to said electrode means for producing unidirectional voltage pulse at a frequency in the range of 90 to 110 hertz and at an amplitude just below the sensory level of said patient, whereby said pulses are applied to a patient for a predetermined treatment period.
non-invasive conductive electrode means for contacting a patient's skin proximate said joint;
pulse generating means connected to said electrode means for producing unidirectional voltage pulse at a frequency in the range of 90 to 110 hertz and at an amplitude just below the sensory level of said patient, whereby said pulses are applied to a patient for a predetermined treatment period.
2. An apparatus as in claim 1 wherein said arthritic joint symptoms are osteoarthritis symptoms which include pain, joint stiffness, limitation of range of motion and limitation of overall function.
3. An apparatus as in claim 2 wherein said pulse generating means includes an oscillator means, a pulse shaping means connected to said oscillator means and an attenuator means connected to said pulse shaping means for producing said pulses at said amplitude just below the sensory level of said patient.
4. An apparatus as in claim 3 further including a capacitive output stage for preventing excessive voltage levels from being applied to said electrodes.
5. An apparatus as in claim 4 wherein said pulses are spiked negative unidirectional pulses.
6. An apparatus as in claim 5 wherein said predetermined treatment period is about 8 hours per day.
7. The apparatus as in claim 1 wherein the electrodes means includes a negative electrodes placed over the arthritic joint and a positive electrode placed on a limb containing said arthritic joint proximal to the negative electrode.
8. An apparatus for treating arthritic joint symptoms, said apparatus comprising: non-invasive conductive electrode means (C) for contacting a patient's skin proximate said joint; pulse generating means (1,2) connected to said electrode means (C) for producing a series of voltage pulses, and means (3) for adjusting the amplitude of the pulses to a level below the sensory level of a patient, characterised in that said pulses are at a frequency in the range of 90 - 110 hertz and are spiked negative-going unidirectional pulses.
9. ~An apparatus in claim 8, wherein said pulse generating means includes an oscillator means (1) and a pulse shaping means (2) connected to said oscillator means and wherein said amplitude adjusting means comprises an attenuator (3).
10. ~An apparatus as in claim 9, further including a capacitive output state (5,6) for preventing excessive voltage levels from being applied to said electrode means.
11. ~An apparatus according to claim 9 or 10, wherein the attenuator (3) is operative to adjust the amplitude of the pulses to a level from zero to minus 10 volts.
12. ~An apparatus for treating arthritic joint symptoms including joint stiffness, range of motion and pain, said apparatus comprising:
non-invasive conductive electrode means for contacting a patient's skin proximate said joint;
pulse generating means connected to said electrode means for producing constant amplitude unidirectional voltage pulses at a frequency in the range of 90 to 110 hertz and at an amplitude just below the sensory level of said patient, whereby said pulses are applied to a patient for a predetermined treatment period, and wherein said pulses are spiked negative unidirectional pulses.
non-invasive conductive electrode means for contacting a patient's skin proximate said joint;
pulse generating means connected to said electrode means for producing constant amplitude unidirectional voltage pulses at a frequency in the range of 90 to 110 hertz and at an amplitude just below the sensory level of said patient, whereby said pulses are applied to a patient for a predetermined treatment period, and wherein said pulses are spiked negative unidirectional pulses.
13. ~An apparatus as in claim 12 wherein said arthritic joint symptoms are osteoarthritis symptoms which include pain, joint stiffness, limitation of range of motion as well as limitation of overall function.
14. ~An apparatus as in claim 13 wherein said pulse generating means includes an oscillator means, a pulse shaping means connected to said oscillator means and an attenuator means connected to said pulse shaping means for producing said pulses at said constant amplitude just below the sensory level of said patient.
15. An apparatus as in claim 14 further including a capacitive output stage for preventing excessive voltage levels from being applied to said electrodes.
16. An apparatus as in claim 12 wherein said predetermined treatment period is about 8 hours per day.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/762,346 US5273033A (en) | 1991-09-19 | 1991-09-19 | Electrical stimulation for treatment of osteoarthritis |
| CA002102759A CA2102759C (en) | 1991-09-19 | 1993-11-09 | Electrical stimulation for treatment of osteoarthritis |
| EP93308995A EP0652028B1 (en) | 1991-09-19 | 1993-11-10 | Electrical stimulation for treatment of osteoarthritis |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/762,346 US5273033A (en) | 1991-09-19 | 1991-09-19 | Electrical stimulation for treatment of osteoarthritis |
| CA002102759A CA2102759C (en) | 1991-09-19 | 1993-11-09 | Electrical stimulation for treatment of osteoarthritis |
| EP93308995A EP0652028B1 (en) | 1991-09-19 | 1993-11-10 | Electrical stimulation for treatment of osteoarthritis |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2102759A1 CA2102759A1 (en) | 1995-05-10 |
| CA2102759C true CA2102759C (en) | 2003-10-14 |
Family
ID=27169540
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002102759A Expired - Lifetime CA2102759C (en) | 1991-09-19 | 1993-11-09 | Electrical stimulation for treatment of osteoarthritis |
Country Status (3)
| Country | Link |
|---|---|
| US (1) | US5273033A (en) |
| EP (1) | EP0652028B1 (en) |
| CA (1) | CA2102759C (en) |
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| TR200708925A1 (en) * | 2007-12-26 | 2009-07-21 | Sanovel İlaç Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ | Combinations of flurbiprofen and muscle relaxants for controlled release |
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| US20100324626A1 (en) * | 2009-06-23 | 2010-12-23 | Management Technologies, Inc. | Electrotherapy Stimilator for Osteoarthritis |
| WO2011044466A1 (en) * | 2009-10-09 | 2011-04-14 | Transkinetic Energy Corporation | Methods of and systems for improving the operation of electric motor driven equipment |
| US20110288611A1 (en) * | 2010-05-18 | 2011-11-24 | Vision Quest Industries Incorporated Dba Vq Orthocare | Bracing and electrostimulation for arthritis |
| WO2013016664A2 (en) | 2011-07-27 | 2013-01-31 | Vision Quest Industries Incorporated Dba Vq Orthocare | Electrostimulation system |
| US9314609B2 (en) * | 2011-10-28 | 2016-04-19 | Martin Brown | Device for providing electrical stimulation of a human knee |
| US20170361091A1 (en) | 2014-12-23 | 2017-12-21 | University Of Pittsburgh - Of The Commonwealth System Of Higher Education | Devices, Systems and Methods for Treating Urological and Gastrointestinal Disorders by Electrical Stimulation of the Foot |
| UY36936A (en) | 2016-03-31 | 2017-11-30 | Medecell S A | PROCESS FOR ESTABLISHING AN ELECTRO-STIMULATION PROTOCOL, AND THE RESPECTIVE ELECTRO-STIMULATION PORTABLE EQUIPMENT USING THE REFERRED PROTOCOL |
| US10806942B2 (en) | 2016-11-10 | 2020-10-20 | Qoravita LLC | System and method for applying a low frequency magnetic field to biological tissues |
| WO2018204492A1 (en) | 2017-05-04 | 2018-11-08 | University Of Pittsburgh - Of The Commonwealth System Of Higher Education | Peripheral neuromodulation to treat bladder and bowel dysfunction |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3881494A (en) * | 1973-05-22 | 1975-05-06 | Jr James M Paul | Electro pulse arthritic physiotherapy system |
| US3902502A (en) * | 1974-09-13 | 1975-09-02 | Saul Liss | Apparatus for temporarily arresting arthritic pain |
| US4155366A (en) * | 1975-06-09 | 1979-05-22 | Ultra-Aids, Inc. | Method of percutaneous pain alleviation |
| JPS54119792A (en) * | 1978-03-03 | 1979-09-17 | Iriyou Kougaku Kenkiyuushiyo K | Electric stimulation device for removing pain |
| US4632117A (en) * | 1982-08-09 | 1986-12-30 | Staodynamics, Inc. | Simplified transcutaneous nerve stimulating device |
| GB8630273D0 (en) * | 1986-12-18 | 1987-01-28 | Til Medical Ltd | Pharmaceutical delivery systems |
| GB8709489D0 (en) * | 1987-04-22 | 1987-05-28 | Electrotherapy Ltd | Electrical body stimulation |
| JPH085780B2 (en) * | 1989-04-28 | 1996-01-24 | 呉羽化学工業株式会社 | Osteoarthritis treatment |
| US5273033A (en) * | 1991-09-19 | 1993-12-28 | Murray Electronics Associates Limited Partnership | Electrical stimulation for treatment of osteoarthritis |
-
1991
- 1991-09-19 US US07/762,346 patent/US5273033A/en not_active Expired - Lifetime
-
1993
- 1993-11-09 CA CA002102759A patent/CA2102759C/en not_active Expired - Lifetime
- 1993-11-10 EP EP93308995A patent/EP0652028B1/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| US5273033A (en) | 1993-12-28 |
| EP0652028B1 (en) | 2000-04-19 |
| EP0652028A1 (en) | 1995-05-10 |
| CA2102759A1 (en) | 1995-05-10 |
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