|Publication number||USRE42489 E1|
|Application number||US 10/140,370|
|Publication date||Jun 28, 2011|
|Filing date||May 8, 2002|
|Priority date||Jan 23, 1998|
|Also published as||US6058938, WO1999037223A1|
|Publication number||10140370, 140370, US RE42489 E1, US RE42489E1, US-E1-RE42489, USRE42489 E1, USRE42489E1|
|Inventors||Jennifer Chu, Peter Styles|
|Original Assignee||JusJas LLC, Oxford Instruments Medical Limited|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (13), Non-Patent Citations (17), Referenced by (4), Classifications (15), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present invention relates to pain management. In particular, the invention relates to intramuscular stimulation therapy utilizing pin penetration and electrical stimulation to help relieve acute, subacute and chronic nerve-related pain for which a specific cause cannot be determined, and for which medicinal and other usual methods of pain relief have proven ineffective, i.e., neuropathic pain. It will be understood that, except as otherwise indicated, “pain” as used herein broadly encompasses severe pain as well as discomforts and early manifestations of pain such as muscle soreness, stiffness, achiness, tightness, tenderness and fatigue.
Conventional pain management is directed toward treating the symptom and not the cause of pain. Conventional methods of treating pain include, as broad categories: (1) medications, (2) physical therapy, (3) chiropractic manipulation, (4) epidural injections or nerve-root blocks, and last but not least (5) surgery. Most of these techniques can be used only for a limited number of times and are not helpful in the long-term management of chronic myofascial pain. The management of chronic pain due to repetitive strain injuries is a $120 billion dollar business in the United States, by 1994 estimates of the U.S. Occupational Safety and Health Administration (OSHA). Low back pain alone is a leading cause for physician visits, second only to the common cold. Neurophysiologically and anatomically based pain management methods which do not use drugs are an effective alternative to conventional care.
As described in the present inventor's copending application Ser. No. 08/856,064 (hereby incorporated by reference in its entirety), non-chemical, non-electrical intramuscular stimulation (IMS) is used effectively in the management of regional and diffuse myofascial pain (fibromylagia) of radiculopathic origin where musculoskeletal pain resulting from muscle shortening is the predominant feature. Unlike acupuncture, where many pins which remain stationary are inserted into points on imaginary meridians, in IMS generally only one pin is used at a time. The pin, which is inserted into a tender muscle motor point, is continuously manipulated to achieve pain relief. The IMS technique was pioneered by C. Chan Gunn, M.D. and is described in the following publications, each of which is, in its entirety, incorporated by reference herein: Gunn C. C. et al., Dry Needling of Muscle Motor Points for Chronic Low-Back Pain, A Randomized Clinical Trial With Long-Term Follow-Up, Spine, Vol. 5 No. 3, May/June 1980, pp. 279-291; Gunn C. C., The Gunn Approach to the Treatment of Chronic Pain—Intramuscular Stimulation for Myofascial Pain of Radiculopathic Origin, 2d Ed., Churchill Livingston, London, UK (1996).
Building on the work of Gunn, and based upon a clinical study of pain relief experienced by patients who have undergone electromyography (EMG) to determine the effects of IMS on pain symptoms, the present physician inventor developed and has used with success a modified IMS technique—twitch obtaining IMS. In EMG, a pin electrode is inserted into muscles for detection of electromyographic signals. During EMG, the pin is moved in all directions for examination of the electrical activity of the muscle during rest, and minimal and maximal contraction. The inventor's modified IMS technique (twitch obtaining IMS) focuses on eliciting twitch responses from muscles by stimulation of motor end plate zones, as opposed to stimulation of motor points as described by Gunn. In the inventor's original technique, a somewhat randomly directed needle insertion was followed with needle movement in all directions and at different depths in the muscle, as in EMG studies, in order to localize and accurately position the pin in the motor end-plate zone. See Chu J., Myofascial Pain Syndrome—Trigger Points, J Musculoske. Pain, 5(1): 133-135, 1997; Chu J., Does EMG (Intramuscular Stimulation) Reduce Myofascial Pain Due To Cervical Radiculopathy, Electromyogr. Clin. Neurophysiol. 37:259-272, 1997; Chu J., Twitch-Obtaining Intramuscular Stimulation: Its Effectiveness in the Long-Term Treatment of Myofascial Pain Related to Lumbosacral Radiculopathy. Arch. Phys. Med. Rehabil. 78:1024, 1997; Chu J., Twitch-Obtaining Intramuscular Stimulation: Effective for Long-Term Treatment of Myofascial Pain Related to Cervical Radiculopathy, Arch. Phys. Med. Rehabil. 78:1042, 1997; and Chu J., Dry Needling (Intramuscular Stimulation) in Myofascial Pain Related to Lumbosacral Radiculopathy, European J. Phys. Med. Rehabil. 5(4):106-121, 1995 (each publication hereby incorporated by reference in its entirety). Later, the present inventor observed that increased pain relief effects could be obtained by needling muscle tender points with a simple in-out motion of a needle along the myofascial bands of the muscles.
In contrast to conventional pain management, IMS, and particularly twitch obtaining IMS, is an effective procedure which can be used repetitively throughout the lifetime of the chronic pain patient, without endangering the health of the patient or causing substantial adverse side effects. The pins used generally cause little trauma, and tissue damage, if present, is generally microscopic. IMS, particularly twitch obtaining IMS, has the capacity to help patients in chronic pain on a mass, world-wide scale, as regional and diffuse myofascial pain, e.g., due to aging of the spine causing spondylitic radiculopathy, is a ubiquitous problem.
IMS, and particularly twitch obtaining IMS, treats the cause of the pain, i.e., muscles shortened or in spasm due to nerve root irritation. When the muscles are shortened due to spasm from nerve root irritation, the muscles pull or tug on adjacent structures to which they attach such as tendons, ligaments, bones, joints, and intervertebral discs. They also pull on the intramuscular blood vessels and nerves. This unrelentous pulling of the shortened muscles causes more nerve root irritation and resultant muscle shortening leading to a vicious cycle of acute, subacute or chronic nerve related pain. By causing the muscles to twitch with the stimulation of the pin, the shortened muscles are stretched and exercised from within the muscle leading to muscle relaxation. Muscle relaxation in turn leads to less tugging effect on the pain sensitive tendons, ligaments, bones, joints, intervertebral discs, onto which these muscles attach, and therefore pain reduction is achieved. Successive treatments lead to more muscle relaxation allowing the intramuscular nerves to heal by restoration of circulation to muscles and nerves.
IMS has until recently only been performed manually. In accordance with Gunn's teaching, a thin flexible acupuncture needle (pin) is inserted into the patient's flesh utilizing a tubular guide. The pin is attached at its proximal end to a distal end of a plunger which is reciprocable within the guide. The plunger protrudes from the proximal end of the tubular guide to provide a finger grip surface, whereby the plunger (and attached pin) can be advanced and retracted. An example of such a tubular guide is the Showa #6 available from Nikka Industries Ltd., Vancouver, B.C., Canada. In accordance with the inventor's modified manual IMS technique twitch obtaining IMS, the same type of tubular guide can be used. However, a stiffer EMG needle is preferred for certain applications.
Despite their effectiveness in ultimately providing pain relief, manual IMS treatments can be quite painful to the patient. The pain is primarily due to the irregular deflection of the pin from its proper path as it is manually pushed in and pulled out repetitively through tissues of differing resiliencies. With the manual method of IMS, it is difficult to maintain proper positioning and directivity of the pin insertion with each to and fro movement, because of the manual effort required of the physician. As a result, the twitch point is easily lost. In such a situation, the pin direction is changed (often several times) within the muscle in order to return the pin to the vicinity of the twitch point. This causes significant additional discomfort to the patient, as well as increased bleeding and tissue trauma. Uneven starts and stops within the muscle are also inevitable because the movements are dependent on the treating physician's skill and strength on encountering different resistance of skin, subcutaneous and muscle tissue at any given point. Less pain would be experienced by the patient if the pin movements could be kept regular, even and steady.
In addition, the work involved on the physician's part in performing manual IMS is laborious, tedious, time-consuming and likely to lead to repetitive stress injury. This is due to the repetitive and resisted upper extremity movements required in performing the procedure. The problem for physicians is particularly acute when, as is typically the case, many areas of a patient's body are to be treated in one session, and when the majority of the patients require this type of multi-area treatment. Under these circumstances, physicians performing manual IMS on a long term basis likely will suffer from repetitive strain injuries and eventually have to stop practicing the method.
With the inventor's manual twitch obtaining IMS modality, physical manipulation of the pin (primarily pin reciprocation) is continued at a treatment point until the muscle is fatigued and cannot respond to the reciprocating pin. (twitch exhaustion). Twitch exhaustion by pin manipulation is time consuming. Typically, there may be as many as 5-100 twitches at a given twitch point before the muscle becomes refractory to further stimulation by pin manipulation. In addition to the repetitive stress injury that may be caused to the therapist, typically, it is only possible to treat four twitch points per muscle and a total often muscles within an allotted treatment time of 30-40 minutes. Thus, many treatment sessions may be required to treat all of the afflicted areas. In addition, since the manual method seeks to elicit all twitching at a given point, the pin is usually moved in all four major quadrants and subquadrants in order to evoke the twitches. These movements cause more tissue trauma and pain to the patient
To alleviate the aforementioned problems with manual IMS procedures, particularly twitch obtaining IMS, the present inventor (along with her coinventor) Zen Guo Yan) developed the automated tool and technique which are the subject of U.S. patent application Ser. No. 08/856,064, filed May 14, 1997. In that technique, a needling device providing automated pin insertion, reciprocation and retraction is prepositioned for pin penetration at a chosen site on a patient's skin. The automatic needling device is controlled to automatically advance a pin thereof to a predetermined penetration depth within the patient's flesh, reciprocate the pin back and forth through a predetermined stroke length a predetermined number of times (e.g., 3-4), and retract the pin from the patient's flesh, while the needling device is maintained at the chosen site. Before movement to another site, the cycle is typically repeated up to three times. (Of course, early termination may be required due to patient pain or discomfort, or in the event that the muscle is or has become refractory to further stimulation.)
While the inventor's automatic needling device and method represents a substantial improvement over previous needling instruments and IMS methods, patient pain and tissue trauma could be reduced even further if the requirement of physical pin manipulation (e.g., reciprocation, etc.) to obtain twitches could be substantially reduced or eliminated. Maintenance of the pin at a proper position (for eliciting twitches at the motor end plate zones) would also be facilitated by reduced needle manipulation.
The present physician inventor has found twitch obtaining IMS (both manual and automatic) to be very effective in the acute and long term management of nerve related pain. However, effective twitch obtaining IMS in accordance with the inventor's previous manual and automated modalities is learned through a period of apprenticeship requiring up to a year at least. This limits the number of physicians who can be trained in this method. The device of the present inventor's application Ser. No. 08/856,064 facilitates the training of persons in the technique. However, even with automation of the method, mastery of the technique, including the ability to precisely locate the motor end plate zones and then stimulate the same to elicit twitches, is obtained only after a rigorous and prolonged training period. It would be highly beneficial if the technique could be simplified such that it could readily be taught, not only to doctors, but also to paramedical personnel such as nurses and physician assistants. Such personnel could treat less involved patients as well as institute treatments earlier, leading to increased prevention of chronic pain. This would result in real savings in direct and indirect health care costs, and the technique could be offered more effectively to patients on national and international levels.
Electrical stimulation has been used in muscle diagnostic procedures, e.g., single fiber electromyography (SFEMG). See Stalberg et al., Single Fiber Electromyography, Studies in Healthy and Diseased Muscle, 2d Ed., Raven Press Ltd., New York (1994). In SFEMG, electrical stimulation is used to selectively and reproducibly activate motor axons, and this activity is recorded by a separate micro-electrode to detect neuromuscular transmission disorders. Such micro-electrical stimulation is carried out using a cathode in the form of a monopolar pin insulated to near the tip (e.g., Medelec MF37 Teflon coated monopolar pin). The pin is supplied with pulsed current of short duration (10-50 μs) with either constant current or constant voltage. Amplitudes of 0.5 to 10 milliampere (0.5-30 volts in the case of constant voltage output) have been described. The rate of stimulation has been described to be 10-50 Hz. The reference electrode is a similar needle placed subcutaneously about 15-25 mm away or a surface electrode (e.g., plate or strip such as used for grounding). The positioning of the stimulating electrode is done to obtain a relatively weak stimulus in order to elicit twitches in a small portion of muscle, visible as fine jerking of the stimulating needle or as fasciculation-like twitches. Stronger jerks (elicited from positions near a major nerve branch) are suggested to be avoided as such stimulation activates many motor units and makes selective recording with the SFEMG electrode difficult.
One use of SFEMG is to determine the conduction time across the motor end-plate zones for diagnosis of degenerative muscle diseases such as myasthenia gravis. Correct placement of a recording micro-electrode at the motor end-plate zone for this procedure is accomplished through micro-electrical stimulation to elicit a twitch serving to identify the motor end-plate zone.
Electrical stimulation has also been used to augment needle based pain relief treatments, including acupuncture and IMS therapy.
In electro-acupuncture, acupuncture pins serving as electrode pairs are supplied with constant or pulsed direct current. The pins are placed into traditional acupuncture points along traditional imaginary meridians.
Gunn teaches in his 1996 text, supra, that electrical stimulation can be used in his IMS technique (focused on stimulation of clinical muscle motor points), in place of manual needle agitation, to hasten the release of muscle contracture (pp. 12 and 35-36). Specifically, Gunn teaches (at page 35) that a low-voltage (9-18 V) interrupted direct current may be administered for seconds or minutes to the inserted needle until muscle release is obtained. Gunn further teaches alternatively that the electrical stimulation may be applied for approximately 15-30 minutes, with the current being gradually increased until muscle contractions are visible to confirm that the needles are properly placed.
The standard acupuncture pins used in electro-acupuncture and Gunn's IMS technique are conductive along their entire lengths. As a result, the electrical field which is established extends along the length of the inserted portion of the pin, and is dispersed into the skin and subcutaneous tissues, in addition to the target muscle area. The intensity of the electric field actually established at the target area is difficult to accurately calculate and control.
Any twitch responses obtained by use of these techniques are generally of relatively small size (i.e., microtwitches). As previously described, in contrast to twitch obtaining IMS, these techniques are not focused on elicitation of strong multiple twitches at muscle motor end plate zones. Gunn's method seeks to cause muscle contracture and release (not twitches per se) by stimulation at clinically defined muscle motor points (as opposed to anatomically defined motor end plate zones) and does not account for the present inventor's discovery that the therapeutic effect of the twitches increases with the size and number of the twitches. In electro-acupuncture, since the acupuncture points are located along traditional imaginary meridians, they may or may not coincide with the twitch points. The duration of time for electrical stimulation is not standardized and may vary from a few seconds to approximately twenty minutes, depending on the acupuncturist's style and subjective/empirical evaluations.
The present inventor has found that elicitation of twitches in twitch obtaining IMS is facilitated by initially causing the muscle to be treated to relax. This can be performed using physical agents such as heat, ultrasound, or electrical stimulation. In addition, oral ingestion of muscle relaxants or anti-anxiety agents, such as Valium (5-10 mgm), and a pain medication, such as 1-2 tablets of Percocet (Oxycodone 5 mg, and Tylenol, 375 mg/tablet) or Morphine Sulfate Immediate Release (MSIR), 15-30 mg, 1 hour before treatment can be used. Of all the physical agents that could be used to relax a muscle in order that twitches can be more easily evoked, the present inventor has found electrical stimulation to be the most effective.
For a time beginning in December of 1994, the present inventor supplemented her manual twitch obtaining IMS modality with electrical stimulation in the treatment of patients. In that technique, the electrical stimulation was supplied by surface mounted (skin patch) electrodes receiving a bi-polar exponential decaying current pulse train from a commercially available electronic waveform generating instrument (the H-WAVE, Electronic Waveform Lab, Huntington Beach, Calif.). The electrical stimulation created a relatively wide area electrical field serving to enhance the elicitation of twitch responses generated primarily by manual manipulation (e.g., reciprocation) of a non-electrified pin inserted into a muscle motor end plate zone. As in the inventor's non-electrified manual and automated IMS techniques, twitches were elicited with an acupuncture pin reciprocated with a metal plunger within a tubular guide placed at the twitch point (above the motor end-plate zone). Twitches at a given motor end plate zone generally would be exhausted by in-out reciprocation of the needle before moving on to treat another motor end plate zone. With this technique, maintenance of the pin at the twitch point was difficult since the plunger could not be stabilized adequately, often causing significant sway of the pin away from (and loss of) the twitch point. In addition, the amount of electrical stimulus needed to make the muscle twitch was difficult to assess due to the indirect stimulation provided by the skin-patch electrodes. Ultimately, the present inventor found the technique to be too cumbersome to be used effectively on a routine basis.
In view of the foregoing, it is a principal object of the present invention to provide a simplified and standardized twitch obtaining IMS procedure that medical personnel, including but not limited to doctors, can rapidly be trained in, thus making the procedure available at low cost and on a mass scale. This will lead to reduced absenteeism at work, payout for workman's compensation, and disability expenses. And, a larger number of pain afflicted persons may enjoy happier, and more productive and fulfilling lives.
It is a further object of the invention to improve the effectiveness of IMS pain relief therapy techniques, i.e., to increase and prolong the resultant pain relief, and reduce tissue trauma and patient discomfort associated with the IMS procedure.
Yet another object of the invention is to facilitate and expedite the performance of IMS procedures, allowing a larger number of afflicted muscle areas to be treated effectively in a treatment session, with less effort and risk of repetitive stress injury on the part of the treating physician or other therapist.
These and other objects are achieved in accordance with the present invention by a method of conducting an intra-muscular stimulation pain relief therapy session. A first muscle motor end plate zone, or region of adjacent motor end plate zones, is located within an afflicted muscle of a patient. A pin is inserted into the patient's flesh such that an exposed conductive tip of the pin is placed within or adjacent one of the motor end plate zones. Localized electrical stimulation is provided to the motor end plate zone, or region of motor end plate zones, by conducting an electrical current through an insulated inserted shaft portion of the pin to the exposed conductive tip. The current flows from the tip, through the motor end plate zone, or region of motor end plate zones, and to a reference electrode spaced from the pin. The electrical stimulation serves to elicit twitch responses of muscle fibers associated with motor end plates within the motor end plate zones, unless the motor end plate zones are or become refractory to electrical stimulation. The pin is withdrawn from the patient upon determining that the motor end plate zones are or have become refractory to the electrical stimulation, or, in the event that twitching is evoked by the electrical stimulation, within a time period of the twitching. The foregoing steps are repeated to elicit twitches at a total of at least four treatment points within the afflicted muscle.
The above and other objects, features and advantages of the present invention will be readily apparent and fully understood from the following detailed description of preferred embodiments, taken in connection with the appended drawings.
While localized micro-electrical stimulation of muscle tissue has been used for diagnostic purposes, e.g., in SFEMG (see the Background of the Invention), the therapeutic use of micro-electrical stimulation in the management of regional and diffuse myofascial pain due to spondylitic radiculopathies has not previously been described. The present physician inventor has found that localized micro-electrical stimulation, to elicit painless twitches, can effectively be used in order to obtain enhanced relief from such pain, through a modified form of twitch obtaining IMS, vis, electrical twitch obtaining IMS or ETOIMS™. In SFEMG, only one or two muscle points are tested, and the twitches evoked are barely visible and are no more than a flickering movement in the muscle. The therapeutic effect of the twitch is not appreciated or recognized. In ETOIMS™, treatment is given at 4-10 points per muscle and 10-20 muscles are treated in a treatment session. Some of the twitches evoked are so forceful that the contraction of the muscle is strong enough to move the joint to which this muscle is attached.
A few definitions will facilitate a full understanding of the present inventive method, and its distinction from prior IMS modalities:
For example, in
An analogy can be drawn to wringing out a coat drenched with water, with the sleeves (the most soggy part) turned inside the coat. Electrical stimulation of the muscle at the pre-terminal nerve D and E entry zone (motor point 9) is like wringing the entire coat. As a start, this method is fine because the entire coat is wet. The method becomes ineffective when only the sleeves remain to be dried. Similarly, surface electrical stimulation as used by physical therapists is not effective for treatment of chronic pain where the spasm is multifocally present, especially in certain parts of the muscle. Surface stimulation will contract only the superficial parts of the muscle, and is thus akin to wringing the surface of the coat, when only the sleeves hidden inside the coat need to be wrung. However, at the motor end plate zone where the monopolar pin tip is placed are adjacent terminal nerves A, B, C, F and even G, and their associated motor end-plates. When electrical stimulation is done at this site, the therapeutic effect is excellent, simultaneously reaching many muscle fibers corresponding to nerve terminals A, B, C, F and possibly G (depending on the position of the electrode and the susceptibility of the muscle to electrical stimulation—greater susceptibility found in fresh or recent nerve irritation). The larger area of muscle contraction will produce a larger area of muscle relaxation and stretch the muscle shortening or spasm present in the muscle fibers in that area. Referring again to the wet coat anology, this is similar to using the wringing force to concentrate wringing only at the sleeves, from the shoulder area down to the wrist area, and thus more effectively drying the sleeves. On the other hand, electrically stimulating the motor point 11 where acupuncture pin 13 is placed stimulates only the shallow terminal branches of the nerve E and is less effective. This is comparable to wringing just the wrist area of the sleeve, when the entire sleeve needs to be dried.
In the preferred ETOIMS™ method, electrical stimulation of muscle motor end-plate zones (twitch points) is carried out with an electrical stimulator 21 outputting a fixed amplitude alternating current (biphasic square wave) with an amplitude of 1.0 milliampere, a duration of 0.1 ms, and a frequency of 2 Hz. A minimal voltage of 1.0-5.0 volts is used. Instead of alternating current, an interrupted, i.e., pulsed, direct current may be used. However, AC current is preferred to prevent tissue necrosis.
In contrast to previous uses of electrical stimulation in IMS therapy, in ETOIMS™ the stimulation is provided locally to one or several closely adjacent target motor end plate zones through a coated (insulated) monopolar pin 19 having an exposed conductive tip 17, and a surface (skin mount) reference electrode 23. A skin mount ground electrode 25 is also applied to the patient, as is conventional in EMG diagnostic procedures. A suitable commercially available electrical stimulation unit is the “Keypoint” sold by DANTEC (a Danish company with U.S. distribution from Allendale, N.J.) for EMG diagnostic procedures.
The monopolar EMG pins (e.g., MG 25, MG37, MG50, MG75, MF37 EMG pins sold by TECA Corporation, Pleasantville, N.Y.) preferred for ETOIMS™ are coated with a layer of friction reducing and electrically insulating Teflon, except for the pointed tip 17 (see
The preferred monopolar EMG pins are thicker and thus stiffer than conventional acupuncture pins. Whereas typical acupuncture pins have a shaft diameter of less than 0.01″, the preferred monopolar EMG pins have a larger shaft diameter of 0.016″ (MG pins) or 0.013″ (MF pins). The EMG pins can, therefore, treat deep and tough tissues which the standard, fine, wiry acupuncture pin cannot penetrate, thus allowing easier placement of the exposed pin tip within the target motor end plate zone(s).
With the electrical stimulator turned on, a first motor end plate zone, or region of adjacent motor end plate zones, is located by palpation of an area in the afflicted muscle. Motor end plate zones (and regions of the same) can be identified as rope-like, swollen, lumpy or tender regions along a myofascial band of the muscle. The electrified pin is then inserted into the patient's flesh such that the exposed conductive tip of the pin is placed within or adjacent the target motor end plate zone(s). Due to the localized electrical stimulation, twitch responses from muscle fibers associated with motor end plates in one or several adjacent motor end plate zones are generally obtained immediately upon an initial pin insertion. In contrast, multiple skin and muscle penetrations are often needed to find a twitch point with the prior methods of twitch obtaining IMS (performed without localized electrical stimulation).
In addition, the twitch responses obtained with ETOIMS™ tend to be significantly larger and more forceful than those obtained with the prior methods. Larger twitches result from the activation of a greater number of motor end plates, within one or several adjacent zones, as a result of a single electrified needle placement. This causes the twitching of a correspondingly larger number of associated muscle fibers. It is thus possible to provide a greater amount of pain relief with fewer twitches (and less treatment time) per treatment site. In contrast with the inventor's previous manual modalities, wherein pin reciprocation is used to exhaust the twitches at one point before moving to the next, with ETOIMS™ highly effective pain relief can be provided with a relatively short treatment time per treatment site. This allows many more muscles and treatment sites per muscle to be treated in a single treatment session. Generally, excellent pain relief effects can be achieved with a stimulation duration at each treatment site of 2-5 seconds (5-10 consecutive twitches). After obtaining twitch responses at a given treatment point for between two and five seconds, the pin is retracted and another twitch point within the afflicted muscle is sought and treated. Of course, if the muscle has become fibrotic and thus the associated motor end plate zones are refractory to electrical stimulation, twitch responses will not be obtained. If such a condition is determined, the pin should immediately be withdrawn and another twitch point sought.
Generally, it is recommended that four to ten pin insertions (four to ten treatment sites) per muscle be carried out, and that a total of ten to twenty afflicted muscles be treated in a 30-40 minute treatment session. For the treatment of back and neck pain, a single treatment session may involve treatment of four to ten treatment sites per muscle on three to six muscles on each of a pair of bilateral limbs (arms or legs), as well as fifteen to twenty sites on each side of the spine for treating the paraspinal muscles.
In searching for the twitch point, a single pin insertion mode is used and if the motor end plate zone is correctly located, the associated muscles should immediately twitch. Otherwise, the point is incorrect, or the muscle is refractory to stimulation, and the therapist should retract and reinsert the pin (either automatically by a needling device or manually by pulling the pin away). With ETOIMS™, the pin does not need to be reciprocated within the muscle tissue, except in the case of treating very tight tissues such as the paraspinal muscles, especially of the low back. When the muscle tissue is soft, as is generally the case in the treatment of the limb muscles, generally only a single penetration into the muscle with the electrified pin is needed to evoke the twitches. The twitches initially are obtained by a combination of mechanical and electrical stimulation of motor end-plate zones. Continued elicitation of a series of twitch responses generally is maintained solely by the alternating electrical current.
In accordance with the inventive ETOIMS™ method, the twitching is preferably limited to 2-5 seconds, within which to 5-10 visible twitches generally will occur. The twitch responses can be obtained superficial or deep within the muscle depending on the position of the target motor end plate zone or region of adjacent motor end plate zones to be treated. The electrical stimulation is applied locally and focally to one treatment site at a time, with rapid sequential movement between multiple sites to be treated.
With the manual twitch obtaining IMS method, the pin is usually slanted on entry into the muscle so that as many muscle fibers as possible can be stimulated. Entry into the muscle band radially with respect to underlying bone is usually not done since very few muscle fibers can be stimulated in this manner. In contrast, in ETOIMS™, radial entry into the muscle is generally just as effective as a tangential entry in evoking twitches. Twitch points that usually cannot be stimulated with the manual method can be stimulated with ETOIMS™. With ETOIMS™, repetitive hand movements of the treating physician are greatly reduced. Thus, the treatment poses significantly less risk of injury to the therapist than does non-electrical manual twitch obtaining IMS. Nonetheless, it is recommended that the treatment schedule be limited to eight patients per day, with a total treatment time per session of 30-40 minutes. By eliminating or substantially reducing the need for mechanical pin agitation, the patient experiences significantly reduced pain during and after the treatment. Generally, the electrically induced twitches do not cause any discomfort. ETOIMS™ is relaxing enough that some patients have fallen asleep during treatment, something which never occurs when performing manual twitch obtaining IMS, due to the pain associated with repeatedly moving the pin within the muscle.
In addition, with ETOIMS™, less skill is needed to elicit the twitches because the electrical field can reach and activate multiple motor end-plates with less precise placement of the treating pin within or adjacent to the target motor end plate zone(s). In the inventor's previous non-electrical techniques, more precise placement of the treating pin within or adjacent the target motor end plate zone(s) is necessary to elicit the desired twitch responses. Specifically, the treatment pin has to be very close to the nerve fibers in order to cause the muscle fibers to twitch. Therefore, referring to
In addition to their pain relieving effects, the elicited twitch responses can be used diagnostically to determine the state of the muscles being treated. With fresh nerve irritation, the twitches are forceful; two to three adjacent motor end plate zones may immediately simultaneously twitch (creating a focal muscle “shudder” or forceful composite twitch) with a single pin penetration into the muscle. If the muscle is very tight, twitch responses generally are only palpable or may be unobtainable.
The present inventor has discovered that when the nerves are recently irritated, twitches are easily evoked and they tend to be forcible. Usually with fresh nerve irritation, the twitches are so forceful that they may move the joint where the muscle being treated is attached. This indicates that the nerve is very susceptible to stimulation, especially electrical stimulation. With chronic nerve irritation, the nerve is not susceptible to stimulation with mechanical stimulation and electrical stimulation is more useful. The inability of the muscle to twitch, even with electrical stimulation, means that the muscles are very tight, may be irreversibly shortened and may have gone into fibrosis. This is especially indicated when with repeated treatments, the muscle is unable to respond by twitching. Reversible muscle shortening due to overwork of the muscle or fresh nerve irritation is muscle spasm. When the muscle is irreversibly shortened, there may be permanent damage of the muscle due to fibrosis.
In its simplest form, the ETOIMS™ treatment is done manually with a naked electrified EMG pin (i.e., no guiding structure), as in EMG diagnostic procedures. Because of the extra stiffness of the EMG pins, flexing of the pin during skin and muscle penetration is less than is experienced with acupuncture needles. Nonetheless, the flexing that can occur may cause some pain and tissue trauma to the patient. Accordingly, a pin guide including a constricted orifice through which the pin will emerge to enter the patient's skin and muscle is desirable in order to protect the patient from painful bowing or arching of the pin as it enters the patient's tissues. A constricted orifice of suitable configuration is disclosed in the inventor's aforementioned application Ser. No. 08/856,064. Other methods of preventing the pin from bowing or arching may also be used.
With ETOIMS™, repetitive stress trauma to the treating physician is still a concern, particularly given the large number of treatment points per patient per treatment session. Another concern is that in the event twitches are not obtained on the first needle insertion, there may be a tendency on the part of the therapist to search for the twitch point by manipulating the pin within the muscle, which is very painful to the patient. Such a tendency arises because it is easier to search for a twitch point within the muscle than to re-insert the pin at a different site on the skin, due to the difficulty with skin penetration when pin insertion is done manually. The difficulty increases with the length of the pin and the number of times the pin must be reinserted. To alleviate such difficulties, it is envisioned that the ETOIMS™ treatment could be performed using an automatic needling device of the type described in the inventor's copending U.S. patent application Ser. No. 08/856,064. Such a pin injector would facilitate insertion of an electrified EMG pin into the muscle and facilitate pin reciprocation where required to elicit twitches in extremely tight muscles.
As is generally the case with invasive medical procedures, specialized training and in depth knowledge of the technique on the part of the therapist (whether a physician, nurse, physician assistant or paramedic) is essential in order to achieve beneficial results (and to avoid serious injury to the patient). Along with the above specifications, the following procedural guidelines will enable a therapist skilled in IMS therapy to practice the present physician/inventor's ETOIMS™ modality, focusing on the elicitation of twitch responses by application of localized electrical stimulation to the motor end plate zones.
Patients excluded are those with diseases in which pain is not of neuropathic origin or is too advanced and, therefore, refractory to the ETOIMS™ method, or those patients for whom such treatment would be contraindicated. These include those patients with:
Note: It is always important to grasp muscle tissue and identify the myofascial band before needling is performed.
Note: It is always important to grasp muscle tissue and identify the myofascial band before needling is performed.
The present invention has been described in terms of preferred and exemplary embodiments thereof. Numerous other embodiments and variations within the scope and spirit of the appended claims will occur to persons skilled in the art, from a review of this disclosure.
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|U.S. Classification||128/898, 128/907, 606/169, 606/189, 607/61, 607/59, 606/167, 607/60, 607/48|
|International Classification||A61N1/34, A61N1/36|
|Cooperative Classification||A61N1/36003, A61N1/36021, A61N1/36017|