DE102024115513A1 - Improved device for the treatment of back pain, especially chronic nonspecific lower back pain (CNLBP), using electrical stimulation - Google Patents

Abstract

The present invention relates to an improved device for the treatment of back pain, in particular chronic non-specific lower back pain (CNLBP), by means of electrical stimulation, wherein the device is designed as a garment.

Description

Brief description of the invention

The present invention relates to a device for the treatment of back pain, in particular chronic non-specific back pain in the lumbar region (CNLBP), by means of electrical stimulation.

Many people suffer from back pain today, which can be caused by degenerative changes, unhealthy diet, lack of exercise, and improper posture. Back pain is therefore increasingly leading to a reduced quality of life, whether due to persistent pain, decreased mobility, or other consequences. Chronic nonspecific lower back pain (CNLBP) can be caused by various factors and mechanisms, but a muscular imbalance in the trunk muscles appears to be a key factor. Many different methods are known for treating chronic nonspecific back pain, but not every method is effective enough for every patient to reduce or even prevent back pain. For this reason, new treatment approaches are important.

State-of-the-art treatment approaches for back pain, particularly chronic non-narrowing of the back (CNLBP), include medications with anti-inflammatory and muscle-relaxing effects. However, these are not recommended for long-term use due to their side effects and the fact that they only treat symptoms. Massage and/or acupuncture are further treatment options that can reduce the symptoms of back pain. Another frequently used form of therapy within physiotherapy involves targeted training of the trunk muscles through various, primarily static, strengthening and stabilization exercises. Controlled, randomized studies have repeatedly demonstrated significant positive effects of this treatment method on pain intensity and mobility in CNLBP patients. However, due to low long-term patient compliance, this therapy proves unsuitable for the majority of affected individuals.

Another method for treating back pain, especially chronic non-invasive lower back pain (CNLBP), is electrical stimulation. In transcutaneous electrical nerve stimulation (TENS), electrodes are placed on the skin surface where the pain is most intense and deliver an electrical stimulus to the underlying peripheral nerves, which, according to the "gate control" theory of Melzack & Wall ( Melzack, Wall: Pain mechanisms: a new theory. Science. 1965 Nov 19;150 (699): 971-979 ) is intended to block. In cases where electrical stimulation is applied to weakened but innervable muscles, the procedure is usually referred to as neuromuscular electrical stimulation (NMES). Here, electrical impulses are periodically delivered to the skeletal muscles via one or more electrodes positioned near motor points to trigger muscle contractions by stimulating intramuscular nerve branches. In NMES, the contractions are primarily triggered by the depolarization of motor axons. The artificial induction of muscle contraction has been proven to lead, at sufficient intensity, to an adaptation of the stimulated muscles in the form of an increase in strength and muscle cross-sectional area, similar to normal, voluntary strength training controlled by the central nervous system.

Electrical stimulation is increasingly being used to treat back pain. DE202015102429U1 For example, a therapeutic device for thermo- and electrotherapy is described, in which several electrodes, together with a heating element, are intended to relieve and treat tension and pain in the neck, shoulder, and lower back region. Also in the EP1829580A1 A therapeutic device is described that includes a heating unit and a device for stimulation by electric current. In the WO 2012/116407 A1 as well as the CA 2 414 398 A1 Individual electrodes can be placed on the painful areas of the body and send an electrical impulse to them.

These devices, however, have several disadvantages regarding the treatment of back pain, particularly chronic non-invasive lower back pain (CNLBP). Firstly, the size and arrangement of the electrode pairs are not designed to effectively stimulate and train the muscles primarily responsible for CNLBP. Secondly, the devices do not provide the user with clearly identifiable (anatomical) landmarks for correct positioning, which is essential for effective stimulation of the targeted muscles. If these points are not addressed, as is the case with current technology, the muscles primarily responsible for CNLBP cannot be effectively stimulated. In the worst-case scenario, this can lead to improper strain and a worsening of muscular imbalances in the trunk area.

The object of the present invention is to provide an easy-to-use device that contributes to the relief and/or prevention of back pain, in particular chronic nonspecific lower back pain (CNLBP), by addressing the main cause of CNLBP, namely muscular imbalance, and not merely treating the symptoms. This is achieved by effectively stimulating and thereby training specific regions that are particularly associated with chronic nonspecific lower back pain (CNLBP).

1. a) der Fixierungsabschnitt mindestens ein Befestigungselement aufweist; und
2. b) der Therapieabschnitt auf der Innenseite der Vorrichtung angeordnet ist und in

direktem Kontakt zum Körper des Benutzers steht, wobei auf dem Therapieabschnitt mindestens vier Elektroden angeordnet sind, die derart ausgebildet sind, dass diese dem anatomischen Verlauf der Muskeln m. transversus abdominis und m. multifidus, welche bei CNLBP-Patienten signifikant atrophiert sind, folgen und diese überdecken. In einer bevorzugten Ausführungsform weist der Therapieabschnitt mindestens zwei mittlere Elektrodenpaare auf, die links und rechts neben einem Spalt angeordnet sind und die leicht zu identifizierenden Knochenvorsprünge Spina ilica posterior superior auf der linken und rechten Körperseite leicht überdecken. In einer besonders bevorzugten Ausführungsform sind die mindestens vier Elektroden ferner derart angeordnet, dass diese die Innenflächen des 7-10 Rippenknorpels und der 11-12 Rippe, der lamina anterior (profunda) der fascia thoracolumbalis, dem labium internum der crista iliaca, der spina iliaca anterior superior und dem ligamentum inguinale und quer verlaufend zum Ansatz an der Linea alba die facies dorsalis des Os sacrum sowie den processus mammillares der LWK III-V und SWK I-IV kranial zu ihrem Ansatz am Dornfortsatz eines drei bis fünf Wirbel weiter kranial gelegenen Wirbelkörpers überdecken.The present invention therefore relates to a device for treating back pain, in particular chronic nonspecific lower back pain (CNLBP), by means of electrical stimulation, wherein the device is designed as a garment and spans the midsection of a user, wherein the device has a fixation section and a therapy section, in which

1. a) the fixing section has at least one fastening element; and
2. b) the therapy section is located on the inside of the device and in

The device is in direct contact with the user's body, with at least four electrodes arranged on the therapy section. These electrodes are designed to follow and cover the anatomical course of the transversus abdominis and multifidus muscles, which are significantly atrophied in CNLBP patients. In a preferred embodiment, the therapy section has at least two central pairs of electrodes positioned to the left and right of a gap, lightly covering the easily identifiable bony prominences of the posterior superior ilium on the left and right sides of the body. In a particularly preferred embodiment, the at least four electrodes are further arranged such that they cover the inner surfaces of the 7th-10th costal cartilage and the 11th-12th rib, the lamina anterior (profunda) of the fascia thoracolumbaris, the labium internum of the crista iliaca, the spina iliaca anterior superior and the ligamentum inguinale, and, extending transversely to their insertion on the linea alba, the dorsal surface of the sacrum and the mammillary processes of L3-V and S4 I-IV cranially to their insertion on the spinous process of a vertebral body located three to five vertebrae further cranially.

1. a) eine Höhe zwischen 100 mm und 200 mm sowie eine Breite von 95 mm und 150 mm im unteren Bereich und eine Breite von 35 mm bis 60 mm im oberen Bereich auf; und
2. b) die Winkel, gemessen von der oberen Kante am Spalt; im Uhrzeigersinn, der rechte Körperhälfte, 90° 100°, 140°, 130°, 90° 90° betragen, wobei die Elektrode für die linke Körperhälfte eine spiegelverkehrte Anordnung aufweist.

Each of the middle electrodes of the device according to the invention further has in one aspect

1. a) a height between 100 mm and 200 mm and a width of 95 mm and 150 mm in the lower area and a width of 35 mm to 60 mm in the upper area; and
2. b) the angles, measured from the upper edge at the slit; clockwise, the right half of the body, are 90° 100°, 140°, 130°, 90° 90°, the electrode for the left half of the body having a mirror-reversed arrangement.

In one embodiment of the device, a gap is arranged in the therapy section in the spinal region, separating the central electrodes from each other. This gap preferably has a width of 20 mm.

In another aspect of the invention, at least one outer electrode is adjacent to the at least one middle electrode per side of the body, which is separated from the at least one middle electrode by a gap, wherein the gap is preferably 5 mm to 25 mm, particularly preferably 15 mm wide.

1. a) an einem ersten, zur mittleren Elektrode gerichteten Ende eine Höhe 120 mm bis 180 mm und an einem anderen Ende eine Höhe von 50 mm bis 85 mm;
2. b) die Außenelektrode im oberen Bereich eine Breite von 190 mm bis 210 mm, vorzugsweise von 202 mm bis 205 mm;
3. c) im unteren Bereich die Elektrode eine Breite von 150 mm bis 160 mm, vorzugsweise von 153 mm bis 156 mm; und
4. d) die Winkel, gemessen von der oberen Kante am Spalt; im Uhrzeigersinn, linke Körperhälfte, 57.4°, 157.4°, 90°, 90°, 166°, 76°, 130°, 140°;

auf.The at least one external electrode per side of the body of the device according to the invention further has in one aspect

1. a) at a first end, directed towards the middle electrode, a height of 120 mm to 180 mm and at another end a height of 50 mm to 85 mm;
2. b) the outer electrode in the upper area has a width of 190 mm to 210 mm, preferably 202 mm to 205 mm;
3. c) in the lower area the electrode has a width of 150 mm to 160 mm, preferably 153 mm to 156 mm; and
4. d) the angles, measured from the upper edge at the slit; clockwise, left side of the body, 57.4°, 157.4°, 90°, 90°, 166°, 76°, 130°, 140°;

on.

In one embodiment, the electrical stimulation is neuromuscular electrical stimulation (NMES). Preferably, the electrical stimulation is high-frequency (HF) neuromuscular electrical stimulation (NMES) and/or low-frequency (LF) NMES. The individual electrode pairs can emit different frequencies. In one aspect, the HF NMES frequency is 75–90 Hz, preferably 85 Hz, and the LF NMES frequency is 10 Hz to 20 Hz, preferably 15 Hz.

The electrodes are preferably surface electrodes made of carbon-graphite, silver/silver chloride and/or carbon. In one aspect of the invention, at least one electrode emits pulsed signals with a symmetrical bipolar rectangular pulse shape. The pulsed signal preferably has a wavelength in the range of 300 microseconds (µs) to 450 microseconds (µs), particularly preferably 350 microseconds (µs). In another aspect, the emitted signal can be used to deliver an electrical pulse for stimulation through the electrodes for 4 to 10 seconds (sec), preferably 6 seconds, followed by a pause of 1 to 10 seconds, preferably 4 seconds, wherein the start-up phase and the decay phase of the signal intensity are preferably 0.2 seconds to 2 seconds, particularly preferably 0.5 seconds.

Furthermore, the device is preferably designed as a belt. In one aspect of the invention, the belt is made of an elastic fabric, preferably elastane, polyester, neoprene, polyamide and/or polyurethane, particularly preferably polyester and elastane.

In a further aspect of the invention, the at least one fastening element of the fixing section comprises a hook-and-loop fastener, a magnetic fastener, a zipper, buttons, snap fasteners, and/or hooks. In a preferred embodiment, the fastening element is a hook-and-loop fastener. Furthermore, in another aspect, a loop is provided at one end of the strap through which the other, opposite end, of the strap can be passed and fixed using the fastening element.

Furthermore, in one embodiment of the device, it may be provided that it has a control unit with which the individual electrodes can be controlled, the intensity of the stimulation regulated and/or the duration of the treatment can be set.

Although the device was previously described with four electrodes, one aspect of the invention may provide that the at least four electrodes are divided into several electrodes. In such a division, however, it is provided that the divided electrodes are arranged in the same area as the at least four electrodes mentioned previously.

The present invention is characterized by the embodiments in the claims and is further described by the details in the following description, examples and drawings.

Description of the drawings

• 1 Schematic representation of a preferred embodiment of a device according to the invention in the form of a belt, wherein a) a fastening element in the form of a Velcro fastener is arranged on the outside of the belt and b) the therapy section comprises four electrodes on the inside facing the body, two for each side of the body.
• 2 Schematic representation of the inside of a preferred embodiment of the device according to the invention in the form of a belt with corresponding dimensions (size M).
• 3 Schematic representation of a preferred embodiment of the outer surface of a device according to the invention in the form of a belt with corresponding dimensions, where R indicates the radius (size M).
• 4 Schematic representation of a preferred embodiment of the therapy section of a device according to the invention with corresponding dimensions, where R indicates the radius (size M).
• 5 Schematic representation of a preferred embodiment of the arrangement and shape of the electrodes of a device according to the invention with four electrodes, wherein R indicates the radius and ° the angular size (size M).
• 6 Schematic representation of a preferred embodiment of a fastening element according to the invention, wherein a) the hook and loop sides of the fastening element are represented in the form of a hook and loop fastener; b) the diameter and thickness of the hook side of the fastening element; c) a folded end of the strap that is threaded through a loop; d) loop through which the opposite end of the strap is threaded. R = radius; Ø = diameter (size M).
• 7 Schematic representation of a middle electrode and an outer electrode of a therapy section of a preferred embodiment of the device according to the invention with corresponding angular sizes.
• 8 Schematic representation of a preferred configuration of a therapy section with multiple electrodes.

Reference sign

1

Fixation section

2

Therapy section

3

electrode

4

gap

5

Iron

6

Fastener

7

control unit

Detailed description of the invention

The present invention relates to a device for the treatment of back pain, in particular chronic non-specific back pain in the lumbar region (CNLBP), by means of electrical stimulation.

In the following, the articles “ein” and all derivatives thereof, as used here, should generally be understood as “ein/e/es or more”, unless otherwise specified or the singular form is evident from the context.

Where the terms “contains”, “has”, “possesses” and the like are used in the description or claims, these terms shall be understood in the same way as the terms “possessing” or “comprising”, i.e., not exhaustively, unless explicitly stated otherwise.

The device described here for electrical stimulation, preferably for neuromuscular electrical stimulation (NMES), is intended as a non-invasive and self-administered method for treating back pain, in particular chronic non-specific lower back pain (CNLBP). For this purpose, the device is designed as a garment, preferably a belt. For the sake of simplicity, the device will be described below as a belt; however, it could also be another garment, such as a shirt, blouse, sweater, or similar item, which features a therapy section with corresponding electrodes in the midsection, particularly in the lower back.

The term "strap" here refers to a belt or wide band that can be fastened around the body, preferably around the midsection. During use, the user wraps the device, preferably the strap, around their midsection so that the device is in contact with the user's body. The device, in the form of a strap, is preferably made of elastic fabric. The elastic fabric can be, for example, but is not limited to, elastane, polyester, neoprene, polyamide, and/or polyurethane, as well as a combination of the aforementioned materials. It is necessary that the material of the device exhibits high elasticity, dimensional stability, and resistance so that the device can remain in close contact with the body. Therefore, the device, preferably in the form of a strap, has a composition of 80% polyester and 20% elastane, thus ensuring optimal comfort, freedom of movement, and durability. Another aspect of the invention may provide that different sections of the device comprise different materials. For example, one section of the device may have greater elasticity than other sections to better adapt the device to the user's body shape. Conversely, a section of the device intended for electrical stimulation, for instance, may be more rigid. If the garment is a T-shirt, blouse, or similar item, the use of different materials is particularly important, as a close-fitting and elastic section may be required, especially in the lower back area intended for treatment.

According to the invention, the device has a fixation section (1) and a therapy section (2), such as the 1 can be extracted.

The fixing section (1) serves for fastening and has at least one fastening element (6), which may be a hook and loop fastener, a magnetic fastener, a zipper, buttons, snap fasteners and/or hooks. In a preferred embodiment, the at least one fastening element (6) is a hook and loop fastener, such as the 6 as can be seen. Furthermore, the belt is preferably designed such that it can be used for different waist sizes. For this purpose, one end of the belt has a loop (5) through which the other end of the belt can be passed and fixed using the fastening element (6), such as the 1 and 6 can be removed. In order to quickly and easily attach the device to the waist, in a preferred embodiment the belt has a fastening element in the form of a hook-and-loop fastener (6) on the outside, which is designed such that the hook side of the fastening element (6a) with the flexible barbs is located at the outermost end of the belt, followed by the loop side of the fastening element (6b) with its loops. The belt is therefore closed by pulling one end of the belt through the loop (5) at the other end of the belt until it fits snugly against the body. The adjusted position of the belt is then fixed by means of the fastening element (6), preferably a hook-and-loop fastener. The length of the belt and/or The length of the fixation section (1) depends on the size of the user and his body shape.

The therapy section (2) is a region on the inside of the device, preferably the belt, i.e., the side facing the user's body. At least four electrodes (3) are arranged on the therapy section (2), which are preferably surface electrodes made of carbon-graphite, silver/silver chloride, and/or carbon. Although the aforementioned materials are currently used in electrical stimulation, it cannot be ruled out that other materials or combinations of different materials may be used for the surface electrodes in the future.

In people with back pain, particularly chronic nonspecific lower back pain (CNLBP), the transversus abdominis and multifidus muscles have been found to be significantly atrophied compared to healthy controls. The resulting imbalance in trunk muscle strength in CNLBP patients leads to increased muscle tension, which in turn manifests as dull pain in the lumbar region. Consequently, the device was designed such that the electrodes (3) in the therapy section (2) stimulate and thereby train the transversus abdominis and multifidus muscles to strengthen the weakened muscles and correct the muscular imbalances. The lumbar portion of the multifidus muscle is of particular importance. The electrodes (3) of the device are therefore shaped and arranged to cover the maximum area of these muscles and thus stimulate them as effectively as possible.

How the 1 , 2 and 5 As can be seen, at least four electrodes (3) are arranged within the therapy section (2). The electrode and belt sizes shown in the figures refer to a user with a waist circumference of 86.5 cm to 98.5 cm (size M). For users with a smaller or larger waist circumference, the electrode and/or belt sizes may vary; it can be assumed that the dimensions shown in the figures and below will deviate by ± 20% from the existing sizes for the next smaller or larger size. A first gap (4) is arranged in the area of the spine, which preferably has a width of 20 mm. The term "gap" here refers to a space or the distance between the at least two middle electrode pairs. The device is to be positioned so that the spinous processes of the spine lie precisely in this gap, thus defining the horizontal orientation of the device during use. The at least two middle electrode pairs (3a, 3a'), which are arranged to the left and right of the gap (4), just barely cover the bony prominences of the posterior superior ilium on the left and right sides of the body when the device is applied. This establishes the vertical orientation of the device and enables self-application.

The arrangement of the at least four electrodes (3) within the therapy section (2) is guided in particular by the anatomical course of the transversus abdominis and multifidus muscles in order to achieve maximum stimulation over the largest possible muscle area. The transversus abdominis muscle originates in the inner surfaces of the costal cartilages of the 7th-10th and the 11th-12th ribs, the anterior (profunda) layer of the thoracolumbar fascia, the inner labium of the iliac crest, the anterior superior iliac spine, and the inguinal ligament. The transversus abdominis muscle runs transversely to its insertion on the linea alba. The multifidus muscle, especially its lumbar portion, originates in the dorsal surface of the sacrum and the mammillary processes of L3-L5 and S1-S4 vertebrae. From there, the fibers extend cranially to their insertion on the spinous process of a vertebral body located three to five vertebrae further cranially. It is a multisegmental muscle. To enable the most precise stimulation of the muscles, the at least two middle electrode pairs (3a, 3a') each have at least one electrode on each side of the body, i.e., left and right, shaped like a boot, such as the... 1 , 2 and 5 As can be seen from the following. In the device, the middle electrodes (3a, 3a') preferably have a height between 100 mm and 200 mm, particularly preferably between 120 mm and 180 mm. The width is between 95 mm and 150 mm, preferably between 100 mm and 140 mm in the lower region. In the upper region, the middle electrode (3a, 3a') has a width of 35 mm to 60 mm, preferably between 40 mm and 50 mm. As the 7 The angles that can be extracted are further 90°, 100°, 140°, 130°, 90°, 90° (measured from the upper edge at the slit; clockwise, right half of the body, 3a). The middle electrode for the left half of the body (3a') has a mirror-image arrangement.

Each of the at least one central electrodes (3a, 3a') on either side of the body is bordered by at least one outer electrode (3b, 3b'), which is separated from the at least one central electrode on either side of the body (3a, 3a') by a gap (4b), i.e., a distance (A). The gap (4b) is in a Aspect of the invention: 5 mm to 25 mm, preferably 15 mm. The at least one external electrode per side of the body (3b, 3b') has a height of 140 mm at a first end, i.e., the end adjacent to the central electrode (3a, 3a'). At the other end, the electrode (3b, 3b') has a height of 70 mm. The width of the external electrode (3b, 3b') differs in its upper and lower regions. In the upper region, the external electrode (3b, 3b') has a width of 190 mm to 210 mm, preferably 202 mm to 205 mm. In the lower region, the electrode (3b, 3b') has a width of 150 mm to 160 mm, preferably 153 mm to 156 mm. As the 7 The angles can also be determined by measuring the angles as follows: 57.4°, 157.4°, 90°, 90°, 166°, 76°, 130°, 140° (measured from the upper edge at the slit; clockwise, right side of the body). The same applies in reverse for the other side of the body. The total length of the at least four electrodes (3) is 600 mm. Although the middle electrodes (3a, 3a') and the outer electrodes (3b, 3b') for the respective sides of the body have been described for simplicity as a single electrode (3a, 3a', 3b, 3b'), they can also comprise several electrodes arranged within the arrangement of the middle and/or outer electrodes, such as the 8 can be seen from this.

Due to the fact that the transversus abdominis and multifidus muscles are deep-lying muscles, a preferred aspect of the invention involves neuromuscular electrical stimulation using the electrodes (3). Neuromuscular electrical stimulation allows the stimulus to penetrate deep into the muscle. The stimulus can be high-frequency (HF) neuromuscular electrical stimulation (NMES) and/or low-frequency (LF) NMES. For high-frequency (HF) neuromuscular electrical stimulation (NMES), a frequency of 75-90 Hz, and particularly preferably 85 Hz, was used. Low-frequency (LF) NMES was preferably performed at a frequency of 10 Hz to 20 Hz, particularly preferably at 15 Hz. Alternatively or additionally, it may also be provided that one or more electrodes (3) have electromyostimulation (EMS), transcutaneous electrical nerve stimulation (TENS) and/or electroacupuncture stimulation.

To control the electrical stimulation of the device, the device also includes a control unit (7) with which the individual electrodes (3) can be controlled, the intensity of the stimulation regulated, and/or the duration of the treatment set. Control can be achieved using a keypad with a display on the control unit (7), suitable remote controls, or via an app. In the latter case, the control unit (7) includes a signal transmission unit that establishes communication between the remote control or a mobile device. During use, the user wears the device in such a way that the electrodes (3) are in contact with the user's skin, with the device positioned in the lower back area. During use, the user can then operate the device using the control unit (7) by selecting the appropriate buttons on the keypad, the remote control, or via an app. In the case of wireless control, the remote control and/or the mobile device for app control includes at least one signal transmitter unit that sends a command to at least one receiver unit of the device. Additionally, it may also be provided that the progress of the session is monitored using the control unit (7).

In one embodiment, the control unit (7) can send the same or differently pulsed signals to the at least one electrode (3), preferably a symmetrical bipolar, rectangular pulse shape being sent to the electrodes (3). In bipolar electrode technology, two identically sized electrodes (3) are used, which interact with each other. Furthermore, in the rectangular pulse waveform (rectangular pulse shape), pulses with a sudden current increase are used for stimulation.

As previously described, a frequency between 10 Hz and 90 Hz, and particularly preferably 15 Hz or 85 Hz, is used. Advantageously, the pulsed signal has a wavelength in the range of 300 microseconds (µs) to 450 microseconds (µs), and particularly preferably 350 microseconds (µs). In one aspect, the signal is configured such that 4 to 10 seconds of stimulation, preferably 6 seconds of stimulation, followed by a pause of 1 to 10 seconds, preferably 4 seconds, are delivered from the electrodes (3) to the user, wherein the start-up phase and/or the decay of the signal intensity are preferably 0.2 seconds to 2 seconds, and particularly preferably 0.5 seconds. The intensity of the delivered voltage of the electrical impulses ranges up to a maximum of 45 volts and can be individually adjusted by the user using the control unit (7). In one embodiment, the lowest intensity can correspond to a voltage of 3 volts and comprise a total of 15 intensity levels, which increase incrementally up to a maximum intensity of 45 volts and can be adjusted via the control unit (7). In another embodiment of the present invention, the duration, frequency, intensity, and/or wavelength can be individually adjusted by the user.

The control unit (7) may also contain means that make it possible to detect the correct fit or hold of the device on the user's body, to prevent overloading of the electrodes (3) and/or excessive use of the electrodes (3).

The electrodes (3) can be powered by batteries, a rechargeable battery and/or an external power supply.

These and other embodiments of the present invention are disclosed in and encompassed by the description and examples. Further literature on known materials, processes, and applications that can be used in accordance with the present invention can be accessed from public libraries and databases, for example, using electronic devices. Furthermore, a more complete understanding of the invention can be obtained by referring to the following examples, which are provided for illustrative purposes and are not intended to limit the scope of the invention.

Examples

Example 1: Investigation of the effect of an invention according to the invention

The study was conducted as a three-arm randomized controlled trial. Participants were divided into three groups: high-frequency (HF) neuromuscular electrical stimulation (NMES), low-frequency (LF) NMES, and conventional back pain training (CT). The HF and LF NMES groups used devices according to the invention, as described in the 1 to 8 The only difference was in the applied frequencies of the electrical stimulation (HF = 85 Hz and LF = 15 Hz). The CT group completed classic back training. The CT training consisted of one 45-minute training session per week, during which, after a 5-minute warm-up, a circuit of eight trunk-specific exercises was performed. The circuit was structured so that 60 seconds of training were followed by 30 seconds of rest. The exercises included: a) Crunch b) Plank c) Bird dog d) Side plank e) Superman f) Static hip bridge g) Dynamic hip bridge h) Sit-up.

The participants undergoing high-frequency (HF) neuromuscular electrical stimulation (NMES) used a device according to the invention in the form of a belt, as described in the 1 to 6 The stimulation parameters were a symmetrical bipolar, rectangular pulse waveform with a frequency of 85 Hz and a wavelength of 350 microseconds. The stimulation duration was 6 seconds followed by a 4-second pause, with a start-up and decay phase of 0.5 seconds each. Participants selected the stimulation intensity to correspond to a subjective rating of 7/10 on an intensity scale from 0 (no intensity) to 10 (maximum intensity). The belt was worn with one pair of 100 mm x 90 mm electrodes (3) positioned on the lower back and the other pair of electrodes placed in the region of the lateral abdominal muscles, targeting the multifidus and transversus abdominis muscles. Participants completed two 20-minute training sessions per week with at least one rest day between sessions. To make the stimulation more pleasant, the surface electrodes used in the device were also moistened.

The only difference between the low-frequency (LF)-NMES examination and the (HF)-NMES examination was the frequency of 15 Hz.

The study period for all participants was eight weeks. The main parameters, pain intensity and functional impairment, as well as other parameters potentially influencing the outcome, were assessed using established questionnaires at three time points: before the start (Pre), at mid-intervention (Mid: after four weeks), and after the intervention (Post: after eight weeks). A total of 60 participants were recruited, all suffering from chronic nonspecific lower back pain (CNLBP). Of these, 46 successfully completed the study. A two-way repeated-measures ANOVA was performed. The treatment modality (HF-NMES, LF-NMES, CT) represented the factor between the intervention groups, and the measurement time point (Pre, Mid, Post) represented the factor within the groups. Participants wearing the devices according to the invention showed significant improvements in pain reduction and functional impairment from the Pre to the Post measurement. HF-NMES proved to be the most effective intervention, as significant improvements in pain perception and functional ability occurred earlier and were also the most pronounced.

The results showed that the device according to the invention represents a promising treatment option for patients with back pain, in particular chronic nonspecific lower back pain (CNLBP).

QUOTES INCLUDED IN THE DESCRIPTION

This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions.

Cited patent literature

• DE 202015102429U1 [0005]
• EP 1829580A1 [0005]
• WO 2012/116407 A1 [0005]
• CA 2 414 398 A1 [0005]

Cited non-patent literature

• Melzack, Wall: Pain mechanisms: a new theory. Science. 1965 Nov 19;150 (699): 971-979 [0004]

Claims (11)

Device for the treatment of back pain, in particular chronic nonspecific lower back pain (CNLBP), by means of electrical stimulation, wherein the device is designed as a garment and spans the midsection of a user, the device comprising a fixation section (1) and a therapy section (2), wherein a) the fixation section (1) has at least one fastening element (6); and b) the therapy section (2) is arranged on the inside of the device and is in direct contact with the user's body, wherein at least four electrodes (3) are arranged on the therapy section (2), which are designed to follow and cover the anatomical course of the transversus abdominis and multifidus muscles. Device according to Claim 1 , wherein the at least four electrodes (3) are arranged such that they cover the inner surfaces of the 7th-10th costal cartilage and the 11th-12th rib, the lamina anterior (profunda) of the fascia thoracolumbaris, the labium internum of the crista iliaca, the spina iliaca anterior superior and the ligamentum inguinale and, extending transversely to their insertion on the linea alba, the dorsal surface of the sacrum and the mammillary processes of L3-V and S4 I-IV cranially to their insertion on the spinous process of a vertebral body located three to five vertebrae further cranially. Device according to Claim 1 or 2 , wherein a gap (4) is arranged in the therapy section (2) in the area of the spine, which preferably has a width of 20 mm and wherein the therapy section (2) particularly preferably has at least two middle electrode pairs (3a, 3a') which are arranged to the left and right of the gap (4) and slightly cover the bony prominences of the posterior superior ilium on the left and right sides of the body. device according to one of the Claims 1 until 3 , wherein a) each middle electrode (3a) has: i) a height between 100 mm and 200 mm and a width of 95 mm and 150 mm in the lower region and a width of 35 mm to 60 mm in the upper region; ii) the angles of the electrode (3a), measured from the upper edge at the slit, clockwise, for the right half of the body, are 90° 100°, 140°, 130°, 90° 90°, and iii) wherein the electrode (3a') for the left half of the body has a mirror-image shape; and b) at least one outer electrode per body side (3b, 3b') adjoins the at least one middle electrode per body side (3a, 3a'), which is separated from the at least one middle electrode (3a, 3a') by a gap (4b), wherein the gap (4b) is preferably 5 mm to 25 mm, particularly preferably 15 mm, wide, and preferably wherein the at least one outer electrode per body side (3b, 3b'): i) has a height of 120 mm to 180 mm at a first end directed towards the middle electrode (3a, 3a') and a height of 50 mm to 85 mm at another end; ii) has a width of 190 mm to 210 mm, preferably 202 mm to 205 mm, in the upper region; iii) in the lower region the electrode (3b, 3b') has a width of 150 mm to 160 mm, preferably of 153 mm to 156 mm; iv) the angles, measured from the upper edge at the slit, clockwise, right body half (3b), have 57.4°, 157.4°, 90°, 90°, 166°, 76°, 130°, 140°; and v) the electrode for the left body half (3b') has a mirror-image shape. device according to one of the Claims 1 until 4 , wherein the electrical stimulation is neuromuscular electrical stimulation (NMES), preferably wherein the electrical stimulation is high-frequency (HF) neuromuscular electrical stimulation (NMES) and/or low-frequency (LF) NMES, wherein a) the HF NMES has a frequency of 75-90 Hz, preferably 85 Hz; and b) the LF NMES has a frequency of 10 Hz to 20 Hz, preferably 15 Hz. device according to one of the Claims 1 until 5 , wherein at least one electrode (3) emits pulsed signals with a symmetrical bipolar rectangular pulse shape, wherein the pulsed signal preferably has a wavelength in the range of 300 microseconds (µs) to 450 microseconds (µs), particularly preferably 350 microseconds (µs), and wherein a signal emitted by the electrodes preferably provides an electrical impulse for stimulation for 4 to 10 seconds, preferably 6 seconds, followed by a pause of 1 to 10 seconds, preferably 4 seconds, wherein the start-up and decay phases preferably each last 0.2 seconds to 2 seconds, particularly preferably 0.5 seconds. device according to one of the Claims 1 until 6 , wherein the garment is a belt, which is preferably made of elastic fabric, which is elastane, polyester, neoprene, polyamide and/or polyurethane, particularly preferably polyester and elastane. device according to one of the Claims 1 until 7 , wherein a) the at least one fastening element (6) of the fixing section (1) comprises a hook and loop fastener, a magnetic fastener, a zipper, buttons, snap fasteners and/or hooks, preferably a hook and loop fastener; b) a bracket (5) is arranged at one end of the strap through which the other end of the strap can be passed and is fixed by means of the fastening element (6). device according to one of the Claims 1 until 8 , wherein the electrodes (3) are surface electrodes made of carbon-graphite, silver/silver chloride and/or carbon. device according to one of the Claims 1 until 9 , wherein it further comprises a control unit (7) with which the individual electrodes (3) can be controlled, the intensity and/or frequency and/or wavelength of the stimulation can be regulated and/or the duration of the treatment can be set. device according to one of the Claims 1 until 10 , wherein the at least four electrodes (3) can be divided into several electrodes (3a, 3a', 3a'', 3a''', 3b, 3b', 3b''', 3b''').