Peripheral Neuromodulation: An Update

Peripheral Neuromodulation: An Update Postępy w Neuromodulacii Obwodowej Teodor Goroszeniuk1, Andrzej Król2 1

Interventional Pain Management and Neuromodulation Practice, London W1, UK Department of Anaesthesia and Chronic Pain Service, St George’s University Hospital NHS Foundation Trust, London SW 17, UK

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ABSTRACT: Peripheral nerve stimulation (PNS) is a rapidly growing area of neuromodulation, with many new indications, including the treatment of chronic pain and functional disorders. Since 1999, when the first percutaneous lead was used for PNS, many new non-surgical treatments appeared that target different body sites. PNS is now a firmly established part of neuromodulation, in which most of the new exciting developments are seen. Non-invasive peripheral external stimulation has an important place in the progress of neuromodulation. Often, it is a less expensive alternative to the implantable treatment, and it can be used outside of specialized centers. Due to the technological advances, PNS is now safer and more efficient, leading to improved outcomes

STRESZCZENIE: Obwodowa stymulacja nerwów (OSN) jest dynamicznie rozwijającą się gałęzią neuromodulacji z rosnącą liczba wskazań do jej stosowania zarówno w terapii bólu przewlekłego jak i zaburzeń czynnościowych. Od momentu wszczepienia pierwszej elektrody przezskórnej w 1999 roku, techniki niechirurgiczne stały się bardzo popularne, a ciągle rosnąca liczba wskazań sprawiła, że OSN stała się ważną częścią neuromodulacji, wyznaczając kierunek rozwoju tej dyscypliny. Nieinwazyjna Obwodowa Stymulacja Zewnętrzna odgrywa istotną rolę w rozwoju neuromodulacji obwodowej oferując znacznie mniej kosztowną alternatywę w porównaniu z elektrodami implantowanymi i może być stosowana poza wyspecjalizowanymi centrami medycznymi. Postęp technologiczny umożliwia bezpieczne i bardziej efektywne stosowania OSN, oferując coraz większy poziom skuteczności i tolerancji oraz zmniejszenie liczby powikłań. SŁOWA KLUCZOWE: Obwodowa stymulacja nerwów • Neuromodulacja obwodowa • Stymulacja zewnętrzna • Stymulacja nieinwazyjna • Ból przewlekły • Poprawa czynnościowa

INTRODUCTION Because of its evolution and dynamic development, peripheral nerve stimulation (PNS) has become one of the most versatile methods of neuromodulation. PNS is not only adaptable but also simple, and it can be used as a stand-alone treatment or in combination with other methods of neuromodulation. In the past, the implantation of first PNS systems required a surgical intervention. Currently, however, transcutaneous leads are used widely, and this approach is now the most extensively developed method of neuromodulation. A percutaneous nerve stimulator was first implanted in the peripheral nervous system in 1999. Then, cylindrical electrodes were

© PTBB  Ból 2017, Tom 18, Nr 1, s. 15-27, DOI: 10.5604/01.3001.0010.0205

used to stimulate the occipital nerves to treat patients with refractory headaches. The technique was later expanded to other peripheral nerves and nerve plexuses to treat patients with neuropathic and visceral pain and patients with pain in the face, heart, abdominal cavity, and lower back. Numerous ongoing studies are investigating how the stimulation of the vagus nerve tibial nerve, or the gastric stimulation affects the symptoms of different diseases, such as epilepsy, urinary incontinence, and obesity. PNS is developing fast and has many indications. Although most reports on the effects of PNS are either observational

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KEY WORDS: Peripheral nerve stimulation • Peripheral neuromodulation • External stimulation • Non-invasive stimulation • Chronic pain • Function improvement

studies or case reports, they provide valuable data that are important to further development. The ongoing randomized trials will give better evidence that will establish how this treatment area will look in future. Because PNS is a complex modality that changes constantly, there is still ongoing debate regarding the appropriate terminology. New techniques will make it easier and safer to implant the electrodes for PNS in the body. Thus, more and more patients will be able to benefit from PNS. Ultrasound guidance during the insertion of the electrodes, and electrode tunneling and implantation of generators (implantable generators, IPG) will cause fewer problems when wireless systems become available. As non-invasive methods of nerve stimulation are also being developed, they will be used more and more commonly by physicians in different specialties.

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HISTORY Peripheral neuromodulation, and more specifically external neuromodulation, can be regarded as the first instance of using electric current for medical purposes. Ancient Greeks and Egyptians used electric fish as a source of electric stimulation, and Scribonius Largus was the first person to describe this method in 46 AD [7]. Gradually, using electric current for the treatment of various diseases became more popular in the nineteenth century, which was accompanied by the development of new techniques. The first Medical Electricity Department was founded at the Guy’s Hospital in London, headed by Golding Bird [135]. In 1885, a safe method of applying high-frequency electric current (10 kHz) was used in humans, which later led to the development of modern diathermy [6]. In 1918, one of the first portable devices, similar to the currently used stimulators for transcutaneous electrical nerve stimulation (TENS), was patented. The transistor neurostimulator and the gate control theory of pain (1965) gave a new framework for the use of electric current in medicine [45, 71]. It is believed that peripheral percutaneous stimulation to relieve pain, described by Wall and Sweet in 1965, opened a new chapter in the field of medical electrostimulation [132]. Shealy et al. implanted the first permanent dorsal column stimulator by laminectomy in 1967 [109]. One year later, Sweet and Wepsic were the first to implant a permanent system for peripheral nerve stimulation [126]. One of the first modern reports on the clinical use of electrostimulation for pain relief, by Rutkowski et al., dates back to 1975 [100]. This report described a successful use of low-frequency (1.5-2.5 Hz) electrical stimulation (ES) for back pain, headache, trigeminal neuralgia, vascular diseases, and cancer-related pain. The publication analyzed 12,000 sessions, each lasting from 15 to 20 minutes, carried out among 786 patients. Initially (1965-1999), all implantations of PNS electrodes were performed by open surgery. In 1999, Weiner and Reed inserted an electrode percutaneously into the greater occipital nerve [133]. The percutaneous insertion of electrodes for PNS increased the interest in using nerve stimulation for treatment, and it prompted dynamic development of this neuromodulation method.

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TECHNOLOGICAL METHODS / CHALLENGES Initially, the electrodes for peripheral nerve stimulation were designed as cuffs that would surround the target nerves. Thus, the placement of those electrodes required an open access, which required surgery. The cuff electrode caused nerve fibrosis, adhesions between the nerve and the electrode, and unintended stimulation by patients’ movements. These complications led investigators to develop paddle (spoonshaped) surgical electrodes. Although the paddle electrodes were better than the cuff electrodes in many respects, the paddle electrodes frequently dislocated, which interrupted stimulation [93]. Because of a lack of good equipment and frequent complications, researchers and clinicians lost their interest in PNS, and only a small group of enthusiasts continued to develop PNS in several specialized centers. Initially (1968-1999), less than 500 patients underwent an implantation of stimulation electrodes, mainly for the treatment of post-traumatic neuralgia in individual peripheral nerves; however, this treatment always necessitated an operation. In 1999, Weiner and Reed were the first to implant a percutaneous nerve stimulator in 15 patients with occipital neuralgia. Among patients with this serious condition, these investigators showed that cylindrical electrodes can be used percutaneously and that open surgery is not necessary. Moreover, they showed that stimulation with percutaneous electrodes had a similar effectiveness but was less invasive and easier to use [133]. Cylindrical electrodes, which are 1.2 mm in diameter, are now standard electrodes for spinal cord stimulation (SCS). The work of Weiner and Reed prompted the development of PNS, which led to many new indications for PNS and new methods of electrode implantation [22, 34, 55, 123]. New indications for PNS include many diseases, such as supraorbital neuralgia [124], atypical facial pain [120], postherpetic neuralgia, ilioinguinal neuralgia [22], ulnar neuralgia [55], and reflex sympathetic dystrophy of the sciatic nerve [114]. New techniques that utilized percutaneous insertion of stimulation electrodes into the peripheral nerves made PNS more feasible. Effective stimulation of the brachial or lumbar plexuses can be an alternative to central nervous system stimulation [35, 88]. The introduction of peripheral nerve field stimulation (PNFS) [34] and subcutaneous target stimulation (STS) (both terms are used interchangeably, with PNFS being more common) made it possible to use PNS to treat patients with diffuse pain, in whom it is difficult to relate the pain to a specific nerve or nerve plexus. In such patients, SCS is not indicated, and PNFS can be used instead. Moreover, PNFS can be used in combination with SCS [34, 72, 79]. Another advantage of using electrodes inserted percutaneously is that the stimulation can be tested during implantation, which is difficult or

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impossible in patients who undergo open surgery. The PNS techniques are based on the principles of local anesthesia, in which nerve stimulation by electrodes implanted with ultrasound guidance is precise and possibly reduces a risk of complications [50].

cases [94, 10]. In experiments involving cats, stimulation of the sciatic nerve and the posterior tibial nerve reduced the response of C-fibers to pain stimuli at the level of the spinal cord pain, which showed the important place of spinal mechanisms in pain modulation.

The long awaited miniaturization of stimulation devices will increase the comfort for patients, reduce the risk of electrode displacement, and provide access to the nerve structures that cannot be stimulated with devices in standard sizes. All these improvements will translate into better treatment outcomes as soon as new techniques that are developed specifically for peripheral nerve stimulation are available. A new type of electrode that uses a wireless power source from an external battery (StimWave) has been developed. Thanks to this development, large internal batteries no longer need to be used to power PNS devices. Moreover, the SimWawe system has another advantage: it can be used during magnetic resonance imaging [105]. Recently, high-frequency stimulation of peripheral nerves has been used in patients with post-amputation pain, and this application of PNS seems promising [119].

The gate control theory of pain does not distinguish between neuropathic and nociceptive pain, although spinal cord stimulation is effective mainly in reducing neuropathic pain. The research performed by Ellrich and Lamp, who investigated the effects of peripheral nerve stimulation in somatic pain, gave promising results [24]. These researchers used infrared stimulation to activate nociceptive A-delta fibers and nonmyelinated C-fibers in the superficial radial nerve (a sensory branch of the radial nerve). In the studies performed by Ellrich and Lamp, participants experienced an unpleasant stinging sensation due to laser stimulation, and researchers recorded and measured cortical evoked potentials. Low-frequency stimulation of the sensory branch of the radial nerve reduced both the pain and the amplitude of the evoked cortical potentials, and these effects were not observed in the control group. These research findings suggest that stimuli inducing pain can be modified by peripheral stimulation.

Peripheral nerve stimulation is one of the fastest growing fields of neuromodulation. The ongoing technological progress and the new equipment developed specifically for stimulation of peripheral nerves will guarantee that PNS will continue to improve.

MECHANISM OF PERIPHERAL STIMULATION The gate control theory of pain, put forward by Wall and Melzack, is the theoretical framework within which researchers in the field of spinal cord stimulation describe potential mechanisms of pain reduction by electrical stimulation [61,62,63]. Direct stimulation of the nerves reduces their excitability, increases the stimulation threshold, and reduces the conduction velocity along the nerves [51]. According to the gate control theory of pain, the paresthesias experienced by patients undergoing peripheral stimulation are conducted by the Abeta fibers. It is very likely that the mechanism of action of peripheral stimulation is very similar to that of the spinal cord stimulation, because the same A-beta fibers run medially both in the posterior horns and the posterior cords of the spinal cord. In animal models, it has been shown that low-frequency stimulation of A-delta fibers increases the long-term depression of monosynaptic and polysynaptic excitation potentials in the substantia gelatinosa of the spinal cord. This effect in the substantia gelatinosa persisted for up to several hours after cessation of stimulation, and it was long-term in some

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STIMULATION OF SINGLE NERVES The basic techniques of percutaneous placement of stimulation electrodes are similar to the techniques used for locoregional anesthesia; electrical stimulators and ultrasound guidance are used simultaneously. It seems that the combined use of nerve stimulation (functional method) and ultrasound (anatomical method) is best for finding the target nerve or plexus. The nerves or plexuses can also be found based solely on the location of some anatomical landmarks; this technique is used by some clinicians, mostly surgeons. The first reports of percutaneous stimulation of single nerves involved patients with mononeuropathy of the supraorbital nerve [22]. Soon thereafter, many investigators used percutaneous stimulation of single nerves in patients with diseases of other nerves, such as the median, ulnar, tibial, ilioinguinal, and genitofemoral nerves [55, 114, 120]. A standard set of equipment for spinal cord stimulation, including a cylindrical electrode (1.2 mm in diameter), long remained the only available way for peripheral nerve stimulation. That equipment, particularly the implanted pulse generators, was very large because it had not been developed specifically for the stimulation of peripheral nerves. This equipment inadequacy made it difficult to use PNS in patients with the diseases of the face or limbs. Connecting the electrode in the target organ to the stimulator placed elsewhere in the body, sometimes far away from the stimulation electrode, often required extension cords that would run, for example, through the shoulder. Because of these difficulties, each patient had to require a personalized planning for an implantation of stimulating system.

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An innovative stimulation cannula (CoudeStim) is an example of a simple device for stimulation of peripheral nerves. This cannula enables nerve stimulation during electrode insertion, which shortens the procedure and improves the precision of electrode placement [42].

It was perceived as a great advancement when the implanted pulse generator was placed near the stimulation electrode in patients requiring stimulation of the sciatic, ulnar, or medial nerves [55, 112, 114]. Another logical step to improve the implantation techniques for PNS devices was to reduce the unnecessary tunneling by introducing single-incision procedures. These minimally invasive procedures proved useful because the cylindrical electrodes that had been inserted percutaneously to stimulate individual peripheral nerves remained stable for long time. The long awaited miniaturization of devices for PNS and recently developed PNS techniques open creative possibilities for this treatment method. Such new PNS systems are now being thoroughly assessed in clinical trials [17, 20, 105, 118]. We can expect that the availability of a new generation of peripheral stimulators will revolutionize the entire field of neuromodulation and will ensure a further dynamic development of PNS.

STIMULATION OF NERVE PLEXUSES

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Brachial Plexus Stimulation (BPS) Neuropathic pain in the upper limb is often difficult to treat effectively. Complex Regional Pain Syndrome occurs in about 5% of patients who have suffered nerve damage. Women develop reflex sympathetic dystrophy more often than men (female-to-male ratio, 4:1) [122]. The upper limb is a very good target for neuromodulation because it is relatively easy to stimulate precisely the area that requires stimulation, which can be done with different methods, such as SCS, dorsal root ganglion (DRG) stimulation, and deep brain stimulation (DBS). SCS and DRG stimulation require interventions at the level of the spinal cord, and DBS at the brain. The peripheral stimulation of the brachial plexus is not only simpler but seems to be more effective compared to SCS, DRG stimulation, and DBS. The first patient who underwent peripheral stimulation of the brachial plexus had extremely strong neuropathic pain (10/10) caused by brachial plexus injury; the pain co-occurred with arm paralysis on the affected side [32]. A preliminary, direct stimulation of the brachial plexus with low-frequency electric current (2 Hz) for 5 minutes relived the pain by 95% for seven hours. Subsequently, the stimulation electrode was inserted percutaneously into the brachial plexus from posterior access. Using the electrode in that site, stimulation with electric current at a frequency from 2 Hz to 10 Hz reduced the pain by 95%, which was similar to the effect of the preliminary stimulation. Notably, after the treatment with the percutaneous electrode, allodynia resolved within several hours after the procedure, and a normal sense of touch returned within several weeks. The arm function continued to improve slowly over the next three months [35]. Currently, insertion of stimulation electrodes via the medial supraclavicular access under the guidance of stimulation, ultrasonography, or fluoroscopy is the method of choice [40]. This method is effective and much easier than the insertion from the posterior approach. An interesting variant of the medial approach,

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which involves ultrasound guidance, was proposed by Bouche from Nantes. The team from Nantes gained experience in BPS by successfully giving this treatment to patients who had not responded to SCS [12]. To date, brachial plexus stimulation has been described in about fifty patients. Preliminary stimulation, for up to 2-3 weeks, can be performed in most settings. This stimulation can be achieved with simple, inexpensive catheters that are typically used for continuous peripheral anesthesia. Using brachial plexus neuromodulation together with a continuous block to treat patients with upper limb ischemia may be a viable therapeutic option [73]. BPS may be considered as the most attractive method of nerve stimulation in patients with pain of the upper limb. However, it would be useful to compare the effects of BPS with those of standard treatment used in these patients.

Stimulation of the Lumbar Plexus/ Paravertebral Stimulation Stimulation of the lumbar plexus can be beneficial in patients with pain in the hip and knee joints; moreover, it is helpful in patients who do not respond or who cannot undergo SCS or DRG stimulation. It is relatively simple to insert a stimulation electrode percutaneously into the lumbar plexus from paravertebral access at the L4 level when one uses continuous diagnostic stimulation (2 Hz) and direct fluoroscopy or ultrasound guidance. In a small study among patients with vertebral pain, stimulation of the lumbar plexus relieved pain in three quarters of patients, and, in two patients, pain relief was achieved despite unsuccessful spinal cord stimulation [88]. Paravertebral stimulation at the level of the chest can be a promising alternative to SCS or DRG stimulation for patients with unilateral chest pain. Paravertebral stimulation offers good electrode stability and substantial pain relief. The paravertebral stimulation is based on the same principles as the standard techniques of paravertebral anesthesia [48]. Both methods seem to be effective and simple, but these observations are based on evidence from few reports and therefore larger clinical trials are needed.

Nerve stimulation for headache and facial pain In 1999, Weiner and Reed were the first to implant a percutaneous nerve stimulator to treat occipital neuralgia in 15 patients. However, it later emerged that eight of these patients suffered from chronic migraine and not from occipital neuralgia [133]. Because nerve stimulation was also successful in the patients with migraine, occipital nerve stimulation (ONS) was recommended as a  therapy for chronic migraine. It is suggested that ONS is effective in chronic migraine because the signals from the trigeminal nerve, dura mater, and cervical spinal nerves converge in the brainstem [74, 103].

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The great occipital nerve is a branch of the C2 spinal nerve, and it is an easy target for stimulation-based treatments. Among 8 patients with chronic migraine who underwent ONS, position emission tomography (PET) showed increased blood ​​ flow in the areas assumed to mediate pain relief, i.e., the posterior pons, anterior cingulate cortex and cuneous [67]. A series of case reports on the promising effects of ONS in patients with chronic migraine prompted large controlled trials assessing the effectiveness of this treatment [64, 103, 115]. Sixty-six patients with drug-resistant migraine were enrolled in the ONSTIM study assessing the effects of bilateral occipital nerve stimulation. The patients were randomly allocated to receive one of the three following treatments: variable ONS, fixed ONS, and medical treatment [103]. Among the patients who received ONS, 39% responded to the variable ONS, and 6% of patients, to fixed ONS. Patients who received medications did not improve. In the PRISM study, 132 patients were randomly allocated to undergo either nerve stimulation or sham stimulation [64]. The stimulation was given to patients for 12 weeks. The primary endpoint was the change in the number of headaches occurring during a month. The number of days with headache among patients who received active stimulation decreased by 5.5 days, compared to 3.9 days in patients who received the sham stimulation. The mean reduction in the number of days with migraine was 27% in the patients who received active stimulation, compared to 20% in those who underwent the sham stimulation. The differences were not statistically significant. In another study, 157 patients with refractory migraine were randomly allocated to receive either active stimulation or sham stimulation (allocation ratio for active:sham stimulation, 2:1) [115]. The primary endpoint was a 50% reduction in pain measured on the Visual Analog Scale (VAS) with no increase in the frequency or duration of headaches. There was no significant difference between the active and sham stimulation in the primary endpoint (50% reduction of headaches) after 12 weeks of treatment. However, there was a statistically significant difference between the groups that received either active or sham stimulation in the proportion of patients who achieved at least a 30% reduction of headaches. These differences translated into a reduction in the number of days with headache by 3.1 days during a month and a decrease in the Migraine Disability Assessment Scale (MIDAS) scores by 44.1 points.

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Cluster headache - Occipital nerve stimulation (ONS) Because the hypothalamus is active during cluster headaches, it was the target of the first neuromodulation attempts to treat patients with cluster headaches who did not respond to medications (43). However, the hypothalamus stimulation led to complications and new targets for nerve stimulation in patients with cluster headaches were tested [58, 59]. In patients with cluster headaches, PET showed an increased metabolism in the hypothalamus, pons, and midbrain. This increased metabolism could be reversed by the stimulation of the occipital nerve [61, 65]. This observation was supported by data from uncontrolled studies investigating the effects of ONS. [16, 66, 108]. Subsequently, a new randomized, controlled trial compared low-frequency and high-frequency paresthesias in each group [134].

Cluster headache - Stimulation of the sphenopalatine ganglion Stimulation of the sphenopalatine ganglion (SPG) is another neuromodulation treatment for cluster headache. The sphenopalatine ganglion lies in the pterygopalatine fossa, and the post-ganglionic parasympathetic and sensory fibers originating from the ganglion run along the blood vessels supplying the face, dura mater, and brain. Initially, blockade and radiofrequency ablation of the sphenopalatine ganglion was used to treat patients with cluster headache who did not improve with standard treatment [4, 77]. The SPG was chosen as the target for neuromodulation because, in animal studies, the electrical stimulation of this ganglion reversed hypoxia and increased blood flow in the relevant area [115]. A study among 28 patients with chronic cluster headache resistant to standard treatment tested the effects of a neurostimulator that was implanted through the mouth, with the tip of the electrode placed in the pterygopalatine fossa [107]. This device was controlled externally via a radiofrequency transmitter. The treatment with the SPG stimulator alleviated cluster headaches in 67.1% of patients, and it reduced the frequency of cluster headaches in 36% of all patients [107]. This improvement in cluster headache symptoms suggests that stimulation of the sphenopalatine ganglion is effective during acute episodes of cluster headache and can be also used in the prophylaxis of these headaches. Temporary sensory disturbances in the face were the most common adverse effects of the SPG stimulation.

Facial pain Nerve stimulation, in the treatment of patients with facial pain, involves the stimulation of nerves located in the pain centers and pathways transmitting pain signals. For example, stimulation of the trigeminal ganglion and the terminal branches of the trigeminal nerve, with both surgical and percutaneous approaches, has been described [49, 136]. Moreover, many investigators have described stimulation of the trigeminal

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The activation of the afferent fibers from the caudal portion of the trigeminal nucleus, at the C2 level, can cause pain in the trigeminal and cervical distributions. Thus, it is hypothesized that electrical stimulation modulating the function of occipital nerves can affect the mechanisms of pain in the areas innervated by the cervical nerves and the trigeminal nerve.

nerve with electrodes placed in the peripheral branches of the nerve [49, 120, 127, 136]; the electrodes were placed percutaneously in the area supplied by the​​branches of the trigeminal nerve. A direct stimulation of the trigeminal ganglion has been used for many indications, such as trigeminal neuralgia, post-stroke pain, peripheral nerve injury, and postherpetic neuralgia. Interestingly, in a case series, Taube et al. observed that stimulation of the trigeminal ganglion successfully relieved pain in 5 of 7 patients after stroke, but it did not improve post-herpetic neuralgia in any patient [127]. This observation could suggest that peripheral nerve stimulation may have an effect on the central mechanisms of pain.

Sacral stimulation Sacral neuromodulation (SN) was first used in 1998, and it proved to be an effective treatment for chronic dysfunction of the diaphragm, pelvis, intestines, and urinary system [27]. In sacral neuromodulation, the devices are implanted surgically, typically at the S3 level, and the electrodes stimulate the sacral plexus with mild impulses. This stimulation enables the treated patients to feel that the urinary bladder is full and needs voiding. Moreover, this treatment helps patients void the urinary bladder spontaneously and completely. The devices for sacral neuromodulation may be used by patients with chronic urinary retention, defecation disorders, intestinal dysfunction, and chronic pain [28, 118].

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Nerve stimulation in visceral pain Chronic visceral pain is treated with blockade of the celiac and lumbar sympathetic plexuses, but the benefits of this treatment are usually short-term. Because blockade of the celiac and lumbar sympathetic plexuses may cause serious complications, repeated treatment or injection of neurolytic drugs are of limited value [19]. In order to obtain long-term analgesia, it is possible to insert the electrodes for electrical stimulation percutaneously in the proximity of the celiac plexus or the sympathetic trunk in the lumbar area. The electrodes are inserted percutaneously under fluoroscopic guidance; they are advanced towards the outer edge of the vertebral body, similar to the techniques used in standard nerve blocks. During the procedure, a test stimulation enables a precise placement of the stimulation field in the target area. To date, the stimulation of the celiac plexus has been used in patients with pain due to pancreatitis, and the stimulation of the lumbar sympathetic trunk has been used in patients with pain associated with chronic hematuria (loin hematuria syndrome). The effects of stimulation were similar in patients with either of the two conditions, and they included pain reduction by 80-90%, reduction of prescribed medications, and a significant functional improvement. The electrodes implanted in the celiac plexus or the lumbar sympathetic trunk remain stable for a long time. Moreover, the first reports indicated that the stimulation of the celiac plexus or the lumbar sympathetic trunk can be used as an alternative to spinal cord stimulation [38,

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39, 86]. The stimulation of the celiac plexus or the lumbar sympathetic trunk is a promising treatment, but it requires further assessments in larger studies. Neuromodulation and invasive procedures used in patients with visceral pain were described comprehensively in 2015 in a book edited by Kapural [86].

Vagal nerve stimulation Vagal nerve stimulation (VNS) has been used to treat drugresistant epilepsy since 1988, when the first implantation was made [18, 82]. Stimulation of the vagus nerve was attempted in patients with drug-resistant epilepsy because, among other observations, in dogs, vagal stimulation inhibited the activity of the nervous system and reduced the number of epileptic seizures [31]. From a clinical perspective, VNS requires an open surgical procedure. A systematic review of the literature showed that VNS can reduce the number of epileptic seizures by 50% [25, 76]. Among patients with epilepsy who underwent VNS, 6% to 27% ceased to have epileptic seizures [18]. VNS was also used to treat patients with depression, but it is not clear how VNS works in this condition [9, 99]. In animal models, the stimulation of the vagus nerve changes neurotransmission in the brain, including the transmission in the adrenergic and serotoninergic systems [67]. Stimulation of the vagus nerve shows promise in treating patients with obesity. Vagal nerve stimulation modulates the vagus nerve fibers responsible for the feeling of satiety, which encourages investigators to assess the effects of this treatment of obesity in large clinical trials [13]. External stimulation (non-invasive) of the vagus nerve or the auricular branch of the vagus nerve is a promising alternative to surgery for obese patients. Preliminary studies show that the stimulation of the vagus nerve and surgery have a similar effectiveness in treating obesity, but the VNS is much less invasive. Different devices for external VNS (ExVNS) are now being assessed in clinical trials [80].

Gastric electrical stimulation Gastric electrical stimulation (GES) is used to treat drug-resistant gastroparesis. The devices that stimulate the stomach are implanted surgically. Usually, several electrodes are placed in the muscle layer of the stomach. The Enterra (Medtronic, Minneapolis, USA) is the most commonly used device for GES; it uses high-frequency and low-energy stimulation [57]. Other devices for GES, such as sequential GES, or low-frequency and high-energy GES, are being assessed in clinical trials. The evidence supporting GES as a treatment for drugresistant gastroparesis is limited; however, in many reports, GES considerably improved quality of life and reduced some symptoms of gastroparesis, such as nausea and vomiting. Stimulation of the stomach is promising, but further studies are needed to improve this treatment [117].

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Many patients experience pain that cannot be related to a specific nerve, nerve plexus, or dermatome. In such cases, spinal cord stimulation or peripheral nerve stimulation do not provide sufficient coverage with paresthesias. In 2000, Goroszeniuk used a new peripheral approach to treat pain in such patients [32, 37]. This treatment was based on the initial experience with the stimulation of the ulnar nerve with low-frequency (2 Hz) electric current applied via mono-electrodes. The treatment relieved pain for 11 weeks. Because of these encouraging outcomes, low-frequency stimulation of target subcutaneous sites was used [32, 34, 37]. Later, similar results were published by O’Keeffe [83]. This treatment was termed peripheral target stimulation (PTS), and it was further extended to peripheral nerve field stimulation (PNFS). This treatment (PTS/PNFS) was first used in three patients with severe neuropathic pain in the chest due to costochondritis, postoperative damage to the intercostal nerves, and postoperative parasternal pain. In all three patients, neurostimulation decreased the pain threshold by 85-90% [34]. Stimulation of the pain center may reduce pain in the entire painful area, including the areas that are not directly targeted by the stimulation. It is extremely important to place stimulation electrodes in the “epicenter of pain” [32, 34]. Before the placement of stimulation electrodes, this “epicenter” of pain can be determined with needle stimulation of the peripheral nerve or with an external nerve mapping device. Then, lowfrequency (2 Hz to 10 Hz) stimulation of varying amplitudes is used. In PTS/PNFS, after the “epicenter” of pain is found, the stimulation electrode is inserted with one of the following tools: a cannula (Abbocath 14G) [78], a Tuohy needle (14 G), or CoudeStim [42]. Then, the stimulation electrode is placed subcutaneously in such a way as to stimulate as large part of the pain area as possible. To improve the technique of inserting stimulation electrodes subcutaneously, a modification was proposed that takes into account the distance from the skin surface to the target site [2]. In a large group of 111 patients with lower back pain, neck pain, and post-herpetic neuralgia, Sator-Katzenschlager et al. showed that PTS/PNFS reduced both the pain index, by more than 50%, and the use of analgesic medications [104]. In another study by Verrills et al., among 100 patients with diverse pain in the face, trunk, abdomen, and pelvis, PTS/PNFS reduced both the pain (by 4.2 points on an 11-point pain scale) and analgesic drug use (by 72%) [131]. Over the last decade, PNFS/PTS, which is a simple method, has been used in many indications [1,60], including stimulation within the chest [34], abdominal wall, [84] lumbosacral region [15,43,44 , 85], knee [70], and for the treatment of shoulder pain [128].

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PNFS is simple and highly effective, particularly in patients with neuropathic pain. PNFS can be used either as a stand alone treatment or in combination with other types of stimulation (spinal cord stimulation, stimulation of single nerves or nerve plexuses). In PNFS, low-frequency stimulation can increase the effectiveness of treatment.

PNFS / PTS in cardiac pain Spinal cord stimulation is considered as an effective treatment for drug-resistant angina pectoris; its effects are similar to those of coronary artery bypass grafting, but spinal cord stimulation causes fewer complications. Therefore, spinal cord stimulation can be considered in patients who cannot undergo coronary artery bypass grafting [23, 61]. In the St Thomas’ Hospital in London, subcutaneous PNFS of the chest wall proved effective in patients with angina pectoris [54, 41]. As regards the technical aspects of PNFS, the insertion of stimulation electrodes is the same as in PTS. Subcutaneous stimulation can be used as a standalone treatment or can be added to spinal cord stimulation when the effect of spinal cord stimulation is insufficient. In two patients who received both subcutaneous stimulation (PNFS/ PTS) and spinal cord stimulation, the subcutaneous stimulation was responsible for more than 90% of the reduction in the number and severity of angina attacks. Because few patients have undergone PNFS/PTS for angina-related pain to date, we still do not know the place of this approach even though the initial observations indicate that this treatment is effective [14, 41]. Currently, the effects of PNFS/PTS for cardiac pain are being assessed in randomized, controlled trials.

Combination of peripheral nerve stimulation and spinal cord stimulation (PNS/ SCS) Peripheral nerve stimulation and spinal cord stimulation can be used at the same time, and the combination of both treatments offers the maximum coverage of the pain area. For example, a combination of spinal cord stimulation and peripheral nerve stimulation can be used to treat axial lower back pain. It is difficult to cover the entire pain area in patients with axial lower back pain by SCS alone, and adding peripheral electrodes to SCS can help enlarge the treated area. Mironer et al. used the term “spinal-peripheral neurostimulation” to describe the combined use of PNFS and SCS. One study compared the effects of either SCS or PNS, or a combination of these two treatments in patients with axial lower back pain. The combination of SCS and PNS was more effective than either SCS or PNS alone in terms of covering the lower back with effective paresthesias [72]. Navarro described the combined use of peripheral subcutaneous electrodes and SCS for the treatment of axial lower back pain as “triangular stimulation”. In a retrospective study involving 40 patients, this “triangular stimulation” improved the pain index and reduced the doses of analgesic medications [79].

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Subcutaneous stimulation (STS), Peripheral Nerve Filed Stimulation (PNFS), Peripheral Target Stimulation (PTS)

The combination of peripheral techniques and spinal cord stimulation has also been used to treat abdominal pain and drug-resistant angina pectoris [41, 113]. In nine patients with pain after ineffective spinal surgery and axial lumbar pain, adding stimulation with subcutaneous lumbar electrodes to SCS effectively enlarged the treated pain area because the SCS alone covered the limb pain but not the back pain. This combined treatment reduced pain to a greater extent than SCS alone. The addition of subcutaneous electrodes increased the area of effective ​​ treatment. The pain index decreased by about 50%, and the doses of analgesic medications decreased by 70% [46].

Minimally invasive stimulation Although new methods of both peripheral and central stimulation are constantly being developed, these treatments are very invasive and costly and require trained personnel. Thus, peripheral and central stimulation are not used commonly. In principle, peripheral and central stimulation should be performed in specialized centers, which guarantees a high effectiveness and the lowest possible complication rate.

ORIGINAL ARTICLES / PRACE ORYGINALNE

Percutaneous electrical stimulation is a feasible treatment for many patients because it is technically simple, cost-effective, and it rarely causes adverse effects. Percutaneous electrical stimulation is often the procedure of choice in smaller centers, in which more advanced methods are not available. Minimally invasive stimulation is performed with needles or stimulation catheters; it is used, in various forms, for both diagnosis and treatment. Minimally invasive stimulation targets individual nerves or plexuses, and it can be used in patients with chronic pain or with pain ​​ that does not correspond to the distribution of dermatomes. In these patients, PTS/PNFS can be used. These treatments involve an insertion of a needle or catheter into the epicenter of the pain area. The stimulation, which is usually low-frequency, is given for 5 min, in PRF; for 5-10 min, in DS; for 20-30 min in PENS; and for 1 week to 2 weeks in the case of trial stimulation with a stimulation catheter. The stimulation sessions can be repeated at regular intervals as a long-term treatment, depending on the indication, outcome of initial treatment, and local guidelines. The equipment needed for minimally invasive stimulation consists of two components: a stimulation generator and a needle or stimulation catheter; all these tools are disposable. In the case of PRF and PENS, the generator is expensive because it contains complex software and electronics. However, using simple stimulators for regional anesthesia in the treatment of chronic pain and for functional improvement of patients is an inexpensive alternative.

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In the 1970s, Rutkowski published several papers on percutaneous stimulation, which he performed with self-designed stimulators. Unfortunately, these devices are not available today. Number of patients treated and the outcomes were impressive. For example, Rutkowski observed that the peripheral stimulation improved hypertension, an observation that is also valid today [100, 101]. Ganome et al. carried out peripheral stimulation by introducing several stimulation needles into the subcutaneous tissue or muscles relevant to the pain area. These investigators analyzed the outcomes of that treatment in a series of randomized trials [29, 30, 47]. The reduction in pain was greater in the treated patients than in the control groups. These studies were, however, not blinded, and the follow-up periods were short, lasting just a few weeks. The technique was named percutaneous electrical nerve stimulation (PENS) [29]. Direct stimulation (DS), introduced in 2000, is short (5-10 min) and of low frequency (2-10 Hz). DS is based on the same principles as the regional anesthesia of the peripheral nerves and nerve plexuses [31]. Unlike PENS, the target of direct stimulation is the nerve itself or the epicenter of pain, and the treatment is carried out with a single needle. This technique proved to be particularly effective in the treatment of patients with neuropathic pain, which encouraged further development of non-invasive methods and different techniques of target field stimulation that are now available [33, 34, 36, 37, 56]. Direct stimulation has become a popular treatment, and it is sometimes referred to as subcutaneous electrical nerve stimulation (SENS) [83]. This simple method can be used routinely for diagnosis and be part of long-term treatment. Percutaneous tibial nerve stimulation is a simple treatment used in patients with incontinence due to bladder hyperactivity. The effectiveness of percutaneous tibial nerve stimulation has been confirmed in a systematic review of randomized trials [11, 74]. The treatment involves a weekly percutaneous stimulation of the posterior tibial nerve. The needle is inserted posteriorly into the medial malleolus, by a person trained in this technique. Long-term studies confirmed the 3-year effectiveness of percutaneous stimulation of the posterior tibial nerve, and the treatment can be repeated for an indefinite period [89]. External stimulation is the next step in the evolution of this treatment, and the results of the initial research are promising.

Non-invasive stimulation (Neuromodulation) Neuromodulation of peripheral nerves was the first instance of using electric current for medical purposes. This method began when ancient Egyptians and Greeks used electric fish, which was documented for the first time by Scribonius Largus in 47 AD [7]. Through the nineteenth and early twentieth centuries, neurostimulation with electric current was used as a treatment method despite a lack of evidence supporting its effectiveness. Then, it was used for many ailments, often by unskilled people, including those without medical training.

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Modern non-invasive neuromodulation dates back to the beginning of spinal cord stimulation. Shelly, who first used dorsal column stimulation (DCS) in 1967 [109], created the first modern device for transcutaneous electrical nerve stimulation (TENS) when he tested SCS transmitters [110, 111]. Currently, TENS is used commonly to treat patients with most pain syndromes. Although we have a vast experience with TENS, and there are many reports on its use, the effectiveness of this treatment is often compared to that of placebo [26, 81, 130]. External stimulation (ExStim) in the treatment of patients with chronic pain, mainly neuropathic pain, is a stimulation involving low-frequency pulses, in which a stimulation pen is used to locate the relevant nerves. ExStim, being a noninvasive technique, has created new treatment possibilities because it is effective and simple [33, 37, 56]. Initial reports showed that patients with chronic neuropathic pain who did not benefit from TENS improved with ExStim. In more than 90% of patients, ExStim significantly reduced the pain threshold; in contrast, TENS either did not reduce the pain threshold or reduced it only slightly [33, 37, 56]. Importantly, ExStim can be used by patients themselves when the initial stimulation improves the pain. Lowering the pain threshold by more than 50% for 6-8 hours is sufficient to qualify the patient for self-stimulation [36]. Current evidence on the effectiveness of ExStim comes from case reports [33, 52, 53, 6, 97, 98], but randomized trials are now being conducted in several European centers [87, 129]. ExStim is used for the stimulation of individual nerves and nerve plexuses, but it can also be used for target/field stimulation in patients with chronic pain or to achieve functional improvement. Non-invasive vagus nerve stimulation (nVNS) in the cervical region or the auricular nerve is a relatively well-documented treatment for patients with headache or epilepsy [21, 80, 121]. The indications for stimulation of the vagus nerve are systematically modified, and vagal nerve stimulation is now being assessed for the treatment of atrial fibrillation [137] and asthma [125]. The newly formed Society for the Stimulation of the Vagus Nerve is a dynamic forum for the exchange of experience related to this important method of peripheral neuromodulation. Transcutaneous supraorbital nerve stimulation (tSNS) is promising, and it may prove to be an effective treatment for patients with migraine [21, 90, 112, 127]. Preliminary reports on the effects of transcutaneous occipital nerve stimulation (tONS) are also encouraging [21]. Transcranial direct current stimulation (tDCS) is used to manage central pain in patients after stroke and in patients with

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visceral pain or phantom pain; in these patients, tDCS is often used as an adjunctive treatment [91]. Transcutaneous posterior tibial nerve stimulation (tPTNS) is another method of transcutaneous stimulation that can be used to treat patients with urinary incontinence or with diseases of the anus. This method is being evaluated clinically. Transcranial Magnetic Stimulation (TMS), since the first clinical trials conducted by Barker in 1985, has been used by more and more investigators to treat, for instance, patients with schizophrenia. The development of technology used for TMS and miniaturization of the equipment will improve outcomes in the treated patients [8, 10]. External stimulation is a fast-developing form of peripheral stimulation. Non-pharmacologic treatment of pain and other diseases will open a new chapter in medicine, particularly because these treatments are used to manage more and more diseases, and not just in pain. Some of the new indications for external stimulation have come from basic sciences. Rheumatic, cardiologic and psychiatric diseases, as well as migraine are among the new indications for external stimulation [3].

FUTURE The increased interest in peripheral nerve stimulation is a consequence of the constantly growing effectiveness of this treatment that has now many new indications; moreover, physicians are keen to have such new treatments at their disposal. Smaller and specially designed devices will increase the effectiveness of treatment in many indications. The increased use of non-invasive techniques and stimulation of targeted subcutaneous areas will increase the availability of peripheral nerve stimulation for doctors and patients. Patients will be able to use their portable devices in a similar way as in TENS. In addition to the current indications such as pain [5, 101, 122], PNS is used more and more in many new indications, such as heart diseases, asthma, arthritis, gastrointestinal diseases, and many immunological disorders. The use of PNS has increased because there are many PNS techniques, which are relatively simple, and PNS improves the functional state of patients [5]. It is very interesting to see how fast new techniques, technologies, and indications are implemented in the field of neuromodulation. Non-pharmacological treatments, such as neurostimulation, are promising because they are effective and cause minor complications; thus, the importance of such treatments will continue to grow. It is necessary to found the practice of PNS on good data from clinical trials. Only then will PNS become an evidencebased treatment option. Clinical trials are needed to assess PNS and will enable its safe development before it is used commonly.

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Because of these problems, neuromodulation ceased to be part of mainstream medicine in the 1920s, and people who offered neuromodulation as a treatment method were sometimes viewed as charlatans.

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Number of characters: 74 585 Number of pages: 13 Tables:– Figures: – References:138 History: Received: 05.12.2016 Reviewed: 28.01.2017  Accepted: 04.02.2017 Conflict of interest: The authors have no conflicts of interest to declare. Copyright: Copyright © 2017 Polish Association for Study of Pain. Published by Index Copernicus Sp. z o. o. All rights reserved. Correspondence author: Teodor Goroszeniuk, Interventional Pain Management and Neuromodulation Practice, London W1, UK, E-mail: teogoroszeniuk@ doctors.org.uk Cite this article as: Goroszeniuk T., Król A. Peripheral Neuromodulation: An Update. Ból 2017: 18(1): 15-27 Table of contents: https://bolczasopismo.pl/issue/10003

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