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Implantation of peripheral nerve stimulator(Stimrouter neuromodulation system)

Learn the Implantation of peripheral nerve stimulator(Stimrouter neuromodulation system) surgical technique with step by step instructions on OrthOracle. Our e-learning platform contains high resolution images and a certified CME of the Implantation of peripheral nerve stimulator(Stimrouter neuromodulation system) surgical procedure.
The use of electrical stimulation for chronic pain has a long history. In the modern era its use spans several decades but it is only over the last 10-12 years, that an evidence base for its use in chronic pain has emerged.
Chronic neuropathic pain remains a huge source of disability and psychological distress and its treatment is difficult and unpredictable.
There are numerous hypothesised mechanisms of action for peripheral nerve stimulators in chronic nerve pain.
The most popular theory is the gate-control theory, which suggest that gates within the dorsal horn laminae in the spinal cord modulate painful and non-painful stimuli via a competitive mechanism. Painful stimuli are carried via small diameter fibres and non-painful stimuli are carried via larger diameter fibres. Flooding the system with non-painful stimuli via the large diameter fibres, closes the gate to the small fibre pathways and reduces the pain signals via these pathways.
Other mechanisms proposed include:
– Stimulation induced blockade of cell membrane conduction, preventing propagation of painful stimuli
– Long-term potentiation of dorsal horn neurones causing decreased excitability and depletion of amino acids such as glutamate and aspartate, which are excitatory amino acids and increased release of inhibitory transmitters such as GABA.
It remains clear that chronic pain is a complex interaction between nerve injury and repair mechanisms, in conjunction with secondary adaptive biological changes, as well as psychological and social factors.
Peripheral nerve stimulation should be seen as one additional technique available to physicians and surgeons treating chronic neuropathic pain. It is important that it is used in the context of a wider appreciation of the causes of pain ensuring that reversible causes are sought and addressed first. Furthermore simpler means of addressing chronic pain must be explored initially as these are successful in many patients.
In general, peripheral nerve stimulation is an option to be considered when a patient’s symptoms have resisted conventional treatment, such as physiotherapy, analgesia, peripheral nerve blockage, desensitisation therapy, exploration, decompression or surgical repair of damaged or entrapped peripheral nerves.
It is important that all chronic pain patients undergo a formal psychological assessment, in order that any psychological contributors are identified and addressed beforehand.
In this section of OrthOracle a peripheral nerve stimulator is implanted into a radial nerve within the arm, to treat chronic unrelenting neuropathic pain carried within fibres of the radial nerve. Onset of pain followed surgery for a malignant tumour in the cervical spine and brachial plexus, which required sacrifice of several routes and injury to others. The pain proved resistant to standard analgesia and neuropathic pain agents and other options were not available.
The peripheral nerve stimulator implanted was the Stimrouter neuromodulation system supplied in the UK by P-14 Systems.
It can be implanted via a percutaneous method or an open surgical method. It is the open surgical technique that is described in this section.
The device includes a low-profile rechargeable external pulse transmitter and a wireless, handheld patient programmer.
Patients apply the external pulse transmitter to the skin in alignment with the implantable lead which sits under the skin. This is done intermittently for minutes or hours at a time and often provides lasting relief for prolonged periods in between stimulation sessions. It is designed to be a long term treatment option.
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Targeted Muscle Reinnervation (TMR) of Superficial Radial Nerve using Axogen Avance processed nerve allograft

Indications:
Peripheral nerve stimulation is indicated in several chronic pain conditions, including trigeminal neuropathic pain, cluster headache and chronic migraine disorders, post-herpatic neuropathic pain, CRPS (complex regional pain syndrome), isolated peripheral neuropathies that are resistant to other forms of treatment.
Peripheral nerve stimulation should be considered when conventional means of treating a patient’s peripheral nerve pain have proved unsuccessful. It is important that the patient is reviewed by a pain specialist, as well as a peripheral nerve surgeon, to exclude reversible causes of peripheral nerve pain. The patient must also have undergone a regime of therapy, which includes physiotherapy as well as nerve modulation therapy, which can be successful at desensitising pain within a peripheral nerve distribution.
Prior to considering peripheral nerve stimulation, correctable nerve pathologies such as a compressive nerve entrapment or an unidentified injury to a nerve or nerve tether within a scar bed should be excluded. These can be looked for by surgeons or a pain specialists experienced in treating these conditions and may involve careful clinical examination in conjunction with nerve conduction studies and imaging.
The following criteria must be met before selecting a patient for peripheral nerve stimulation:
1) Exclusion of reversible nerve pathologies such as an entrapment neuropathy.
2) Pain consistently experienced within an anatomical distribution of a single peripheral nerve, whilst allowing for a degree of central sensitisation, which may blur the boundaries to an extent.
3) A positive diagnostic peripheral nerve block confirming abolition of pain within the distribution of the nerve in question.
History and Examination:
The history will usually establish the timeline of events, evolution of pain and treatment tried to date.
Examination may reveal pain described by the patient as unrelenting burning, tingling or pressure pain. Neuropathic pain in particular has a classic description whereby the patient is unable to find relief with standard analgesia such as opiates and anti-inflammatory medication but may find some relief in standard neuropathic pain agents such as Gabapentin, Pregabalin, Amitriptyline or Duloxetine.
Examination of a peripheral nervous system may reveal sensory and motor loss within the distribution of the nerve. A Tinel’s point should be looked for which may indicate a compressive pathology or may allow localisation of an injury or a nerve tether. Such pathologies are potentially reversible. The patient’s pain may be felt in a cutaneous distribution and this should be carefully mapped out. This will often demonstrate the primary nerve trunk through which the painful stimuli are conducted. This may also reveal neighbouring areas that are more difficult to identify, which may relate to injury to other nearby nerves that have previously been unidentified. They may also relate to hypersensitivity in neighbouring nerve distributions, which is known to occur in longstanding neuropathic pain. Features of central sensitisation should be looked for, such as allodynia (pain in response to a stimulus that doesnot normally cause pain) and hyperalgesia (increased pain from a stimulus that usually provokes pain).
The patient must complete a regular pain score before an after each treatment and before and after any targeted nerve block.
I use a modified McGill score and a visual analogue score (VAS).
Alternative operative treatment:
Alternative treatments have been touched on above and include standard neuropathic pain agents that are prescribed in accordance with NICE guidance CG96 in the UK, which guides the appropriate dose increments and intervals of standard neuropathic agents; these include Gabapentin and Pregabalin.
Unrelenting neuropathic pain may be temporarily relieved by an ultrasound guided nerve block. The effects of this can be prolonged by the addition of some steroid and it can be worth offering patients a prolonged block as part of the work up for a peripheral nerve stimulator or to provide some transient relief. Where there is a compressive pathology or a neuroma, these should be treated medically or surgically, as described elsewhere on OrthOracle.
Contraindications:
The contraindications to peripheral nerve stimulation mainly relate to contraindications for surgery including localised infection or coagulopathy. Other contraindications are a failed diagnostic nerve block or significant psychiatric illness.

This particular procedure is performed under regional anaesthesia with a brachial plexus block. This produces a segmental nerve block proximal to the site of operation but continues to allows the surgeon to stimulate nerves intra-operatively for ease of identification and measurement of stimulation thresholds.
General anaesthetic is a suitable alternative and the two techniques may be used in combination to provide post-operative pain relief.
The patient is placed supine with the operated limb on an arm table.
No tourniquet was used in this case.
Bipolar diathermy was used.
Antibiotics were given at induction due to the use of an implant.
Loupe magnification is recommended when dissecting around nerves.
Standard thrombo-prophylactic policy was adhered to.

The limb is prepared to include the entire hand and as much of the upper limb as is feasible.
This image shows the upper limb with surgical drapes applied just below the axilla.
The benefit of having the entire limb exposed is that the motor response to nerve stimulation can be assessed visually.
Clearly this is an abnormal limb with longstanding loss of radial motors and overactivity of the long finger and wrist flexors as well as the instrinsics.

The incision is marked out in line with the radial nerve in the distal third of the arm. At this point the radial nerve path is out of the lateral intermuscular septum and is seen lying between the brachialis and brachioradialis muscles, where it can be exposed easily. This coincides with a site of a previous successful nerve block.
To mark out the interval between the two muscles, palpating the brachioradialis and then pinching it allows the surgeon to palpate its posterior border just anterior to the humerus. This soft are marks the plane between the muscles and a longitudinal incision here will allow adequate exposure of the nerve.
The line of the incision is usually longitudinal and lies just anterior to the mid lateral line.
If more proximal access to the radial nerve is required, the incision should be curved towards the posterior arm as the nerve sits in the radial groove over the posterior humerus in the mid point of the arm.
Injury to the nerve during the approach described here spares the triceps branches which arise in the infraclavicular plexus and upper arm buut may compromise the the wrist extensors and brachioradialis.

The nerve block is checked by gently pinching the skin to ensure that the patient is not aware of any sensations from the operative area.The anaesthetists will have performed this check beforehand to confirm adequate regional anaesthesia but final responsibility for this rests with the surgeon.
Occasionally the operative site may have some aberrant innervation from a nerve outside the anaesthetised territory. If a complete block has not been achieved, further anaesthetic can be injected by the surgeon to give an additional field block. Alternatively the regional block may be added to by the anaesthetist.
The maximum safe doses of local anaesthestic must not be exceeded during this step.

The incision is made with a number 15 blade.At this layer the nerve is below the level of the fascia and deep within the intermuscular interval.

Bipolar diathermy is used to coagulate any traversing vessels to minimise bleeding.The initial dissection down to deep fascia can proceed fairly rapidly, looking for any cutaneous branches that may lie over the fascia such as distal branches of the posterior brachial cutaneous nerve.

Sharp dissection continues through the fat until the fascia is exposed.Gentle spreading of scissors within the fat minimises bleeding and allows any cutaneous branches to come into view.

Several bleeding vessels within the fat are coagulated with bipolar diathermy to keep the field clean and to allow visualisation of the deeper structures.

A self-retainer is now inserted, which allows the fat to be retracted exposing the fascia. Often inserting the retractor will have a haemostatic effect.
This fascia is the brachial fascia and here is an extension of the lateral intermuscular septum.

Fibres of the brachialis and brachioradialis are identified and the interval between them identifiedBlunt dissection aids separation of these fibres with brachioradialis anteriorly and brachialis posteriorly. As one does this, some further traversing vessels are identified which can be coagulated as seen.
The intermuscular plane is not always immediately obvious. Spreading the fascia apart with blunt dissection will reveal the more superficial and anterior fibres of brachioradialis and the deeper brachialis fibres and a fatty streak between them will reveal the plane that must be entered to expose the radial nerve

The two muscles are carefully separated to expose the nerve passing deep within this intervalThe brachialis is retracted posteriorly and the brachioradialis anteriorly. The plane between this developed with some blunt dissection is seen here.
This part of the dissection needs to be performed very carefully, as the radial nerve will be seen within this plane and inadvertent injury must be avoided.
The nerve is surrounded by a thin layer of fat. Once this is seen, the interval is held retracted whilst the nerve is located running longitudinally through this layer.

This slide shows the radial nerve just below the scissors and some blunt dissection being performed with the scissors just over the layer to ensure that the last remaining fibres of the brachioradialis pass over it, they are separated from the nerve.
A Brachioradialis
B Brachialis – (and fat overlying it)
C Radial nerve
In this wasted arm the muscles are thinned out and the nevrve is only a few mm beneath the fat.
In a normal arm these muscles are more substantial and require an assistance to aid retraction wilst locating teh nerve.

The radial nerve is identified and identity and function confirmed with direct nerve stimulationA- Here the radial nerve is clearly seen lying within its intermuscular plane.
As well is its use in confirming the identity of this nerve, nerve stimulation can also help to determine how much residual function there is within this nerve.
If a tourniquet is used, it is important to know that stimulation becomes unreliable after 20 minutes of tourniquet use and the tourniquet should be released for at least 15 minutes before normal stimulation thresholds are deemed to return.
B – brachioradialis – fibres are being lifted off the nerve with an Adson’s forceps
C – brachialis

The stimulation needle is applied to the nerve making light contact with the epineurium, whilst the hand and wrist are looked at for evidence of motor activity.The surface of the nerve is gently touched with the needle with the electrical current turned on. At this level of the radial nerve stimulation should ordinarily cause wrist extension, finger and thumb extension.
The anaesthetic nerve block stimulator is adequate for this purpose and will allow adjustment of the stimulation current which can be useful in determining how much residual function there is as well as the effect of neurolysis or decompression.
The current applied is gradually turned down until one reaches the minimum current that will elicit a visible muscle contraction. This is the ‘stimulation threshold’ and may be reduced after decompressing or neurolysisng the nerve but can be increased by nerve injury or the effects of the tourniquet. A normally functioning nerve stimulates at a threshold of 0.2 – 0.5mA.
Stimulating different parts of the nerve at the threshold level allow topographical mapping og the nerve which can be useful when identifying individual fascicle groups.
The device used here is the Stim-Aware nerve probe which comes with the implant used in this technique.
As expected in this patient, there is little motor activity seen within the majority of the radial muscles even at the highest stimulation level of 6mA. However, there is some residual activity of EPL and APL at a stimulation threshold of 0.5mA

A circumferential neurolysis of the nerve is performedThe nerve is circumferentially freed from its investing tissue to allow passage of a sloop around it and to allow the implantable peripheral nerve stimulator electrode to also be passed around the entire nerve in subsequent steps.
This dissection involves lifting the nerve by gently holding the surrounding tissue and subsequently the epineurium.
Although this is routine peripheral nerve surgical practice, there is risk to the nerve if it is handled with an inappropriate technique or instrumentation.

A pair of mixture forceps is passed around the nerve, with the nerve gently retracted.After circumferential neurolysis the nerve is mobile. and the mixter can be passed around it.
The jaws of the mixter should not be opened and closed whilst behind the nerve. This risks injury to unidentified branches that may be arising from the deep surface of the nerve.
A single pass and opening is a safe and useful way of creating some space behind the nerve.

A rubber sloop is passed around the nerve. The rubber sloop allows atraumatic handling of the nerve and facilities further dissection proximally and distally.

Once the radial nerve is slooped, gentle retraction using the sloop facilitates further dissection around the nerveSince the implantable StimRouter lead will be placed around the nerve in close contact with it, freeing up the nerve as much as possible within the operative field will allow a good pocket of space around the nerve for subsequent steps.

This image shows the implantable StimRouter lead which is 15cm in length.
A – Stimulation end – This end sits in contact with the nerve
B – Receiver end – This end is implanted near the skin surface – This end receives the stimulation signal from the external pulse transmitter (see next steps) and sends the signal through to the other end, and to the nerve.
The recommended distance between the two ends at implantation is 7cm.

A point 7cm away from the exposed nerve is marked out on the skin A subcutaneous tunnel leading to this point will be made to create a pocket for the implant to pass through.
A – The point where the stimulation end will be implanted next to the nerve
The subcutaneous tunnel is planned to allow the receiver end to sit 7cm away from point A, just under the skin.
The external pulse transmitter will be applied to the skin over these two points and so, wherever possible the superficial, receiver end should be placed at a location where the skin is good quality and away from any bony prominences, troublesome scars or hair bearing areas.

The stimulation end is placed next to the nerve and its final position and route to the subcutaneous, receiver end is planned.The Stimrouter lead is introduced into the operative site to check its final seating position behind the nerve.
The stimulation end has a barb that aids its anchorage near the nerve and helps prevent lead migration.
The aim is to seat the lead in a comfortable pocket near the nerve with the stimulation end in contact with the epineurium.
There will be some redundancy within this 15cm implant, as it coils around the nerve and passes into the subcutaneous pocket 7cm away. this point is marked with a blue cross.

The site for the subcutaneous part of the electrode is marked with a cross.
It is located 7cm from the barbed end of the electrode which sits next to the nerve.
This is the distance recommended by the manufacturer to optimise stimulation of the nerve using the EPT which will sit on the skin surface and has two stimulation electrodes at a fixed distance apart

The subcutaneous tunnel is made for the implant once the final location for each end is decidedBlunt dissection with a Jamieson’s scissors over the fascia allows formation of subcutaneous tunnel.

The electrode is removed and passed into a trocar, which will be used to introduce the electrode through the skin

The trocar is inserted through the skin at the site marked in the previous steps.
The aim is to introduce the electrode through in a retrograde manner, allowing the barbed end of the electrode to pass all the way through, whilst leaving the superficial end just under the skin at the site marked with a cross.

The trocar is passed gently into the exposure, over the surgeons finger which is protecting the nerve.

The trocar is pulled back allowing it to slide over the electrode.

The superficial end of the electrode can now be seen sitting just outside the skin and of course the entire electrode can be pulled through, leaving the superficial end just under the entry point of the trocar.

Distances are remeasured and confirmed once more.
This confirms a distance of 7cm between the two Stimrouter lead ends.
Both ends will sit in the distal arm over the lateral aspect which should be a convenient site for the EPT to be applied.

The sloop around the radial nerve is removed

The implant is pulled through gently until the superficial end sits under the skin at the desired locationThis is a key step where the stimulation end of the lead is placed into its position behind the radial nerve and the lead is then coiled over the superficial surface of the layer, pulling the other end into the subcutaneous pocket.
This will allow the nerve end of the lead to sit behind the nerve in a relatively loose arrangement, whereby the rest of the electrode simply curves around the nerve into the subcutaneous pocket, for its other end to sit at the desired location just under the skin.
This redundancy should allow for some stretching and gliding of the tissues during normal limb movement.
The insulated surface of the lead is coated with a layer of insulating silicon, which one is able to handle gently with some non-toothed forceps. This is required when making final adjustments to the position. The final position of the superficial part of the lead (the receiver end) is critical to the success of the technique since this has to match the position of the electrodes on the EPT in subsequent steps.

Once the stimulation end of the lead is in contact with the nerve at the right point, fibrin glue is used to secure the lead around the nerve.In this case Tisseal (Baxter inc.) is used.
Tisseal is an absorbable, fibrin glue and is only an aid to temporarily fix the position of the lead. It will last long enough for scarring to form in the exposure and maintain the relative position of the lead and radial nerve.
The lead is seated in a position that is tension free in normal elbow range of motion.
Here it is aided by the intermuscular pocket within which the radial nerve sits but will clearly vary for the local anatomy around other nerves.

Further volumes of Tisseal are used at intervals, as the lead curves around the anterior surface of the nerve. This will spot weld the electrode the the tissue envelope and prevent it dislodging during normal limb movements and muscle contraction.

A – The lead can now be seen in its final position, resting around the nerve within a layer of Tisseal.

A layered closure is performed.This is done with 4.0 Monocryl deep and subcuticular sutures after haemostasis and irrigation of the wound.

With the wound sealed, it can now be dressed with some soft dressings.

Steristeps are applied

A non-adherent opsite dressing is applied

A bulky bandage is used to provide some gentle pressure over the woundThe patient is discharged home the same day and is brought back to clinic for a wound check and for an initial trial of nerve stimulation in 2 weeks’ time.

A wound check is performed at 1 week post surgeryAt 1 week following the procedure, the wound looks well healed and the position of the superficial electrode can be seen.
The wound looks clean, healthy and dry and there is no evidence of infection and or irritation. Therefore the initial nerve stimulation can be trialled.
If there are any concerns about the stimulation sites at this stage a further delay is recommended.

A: The box contains the EPT (external pulse transmitter) which generates the signal and transmits it through the electrode through to the implanted lead. This device responds to wireless commands from the patient programmer.
B – The disposable electrode has two two gel pads that adhere it to the skin. These gel pads also transmit the stimulation signal from the EPT to the implanted lead.
The tabs at either end of the electrode are used to peel it away from the skin after use
The disposable electrode typically lasts 2-4 days before being replaced. This depends upon the duration and frequency of stimulation sessions and the number of times it is applied and peeled off.
C- The patient programmer communicates wirelessly with the EPT and is used to turn the stimulation on and off as well as to set the intensity and select stimulation programmes.

The external pulse transmitter is placed with each of its two pads over one of the implanted electrode ends.The EPT and electrode are clicked together. The gel pads on the underside of the electrode stick to the skin and allow the accurate placement, in line with the implanted lead, such that the end nearest the charging point of the EPT (on the right of this image) match the receiver end of the lead. The other end of the electrode can be positioned anywhere as long as it minimises skin irritation and muscle contractions
The exact skin position may initially require some adjustment until the implant and EPT are perfectly aligned and a good transmission is obtained.

This position of the EPT and electrode matches well with the two ends of the lead, as seen on the previous operative slides.

The clinician programming system is used for the initial programming of the patient operated system. This step is performed by a trained representative of the manufacturer or a clinician trained in the setup process.
The tablet computer contains the clinician programming system, which is used for the initial set up of patient operated system. The programmer connector cable links the tablet to the patient programmer. This is used to test and save stimulation parameters into the patient programmer, ready for the patient to use at home.

The clinician set up process requires repeated adjustments and test stimulations that are adjusted according to the patients response.A – The intensity Level bar – This is used to adjust the intensity of the stimulus (0-30 milliamperes peak, 1 milliampere resolution)
B – Programme bar – This can be used to set up multiple stimulation programmes and save them on the patients system
C – Waveform – Set to symmetric or asymmetric
D – Phase duration – A measure of the duration of each pulse.
E – Pulse repetition rate – The number of times per second a pulse is delivered ( 1-200Hz)
Once the correct patient is selected, the ‘Test’ icon is pressed.
The stimulation intensity is increased until the patient feels some nerve stimulation. It is then increased further until paraesthesia is achieved without causing discomfort. The system will disable the ‘Test’ icon if the parameters exceed the maximum permitted stimulation.
During the set up the system automatically increases or decreases the intensity delivered gradually until the set intensity is reached. Time is allowed for this process to take place.
The waveform, pulse rate and pulse duration can all be adjusted to fine tune the stimulation programme.

The final settings are programmed into the patient operated systemAfter the set up it was apparent that this particular patient achieved complete coverage of the neuropathic pain area and excellent pain relief upon initial trialling with the following stimulation parameters: Amplitude 1.4 milliamps
Pulse duration 300 milliseconds
Pulse rate 100
Wave form symmetric
The patient was sent home to continue the initial stimulation regime using the patient operated system. This involves a period of time limited stimulation episodes, to allow the soft tissues to tolerate conduction.
Over subsequent weeks the frequency of stimulation can be increased and then decreased as required by the patient to provide acceptable pain relief.

The patient is usually discharged home the same day with oral analgesia.
With regional anaesthetic it is worth warning the patient of a sudden surge in pain that may occur as the anaesthetic wears off. This can usually be anticipated as the sensation starts to return and can be prevented by early oral analgesics such as cocodamol 30/500.
The dressings are all taken down at the first post-operative clinic visit at 2 weeks post surgery.
If the wound is healing well without evidence of infection, an initial trial stimulation protocol can be commenced as described in the steps above.
There is often a sudden wave of relief as the device is first turned on at the appropriate level of stimulation but it is important to note that the response will change and further adjustments may be required to maintain relief.
The patient continues using the initial protocol for 4 weeks.
At 6 weeks post operation, the patient is reviewed and pain scores taken again for comparison.
Often further adjustments are needed at this stage to either the electrode position on the skin or the stimulation protocol.
The patient needs to only change the sticky gel electrodes periodically to ensure a good contact is maintained.
Over subsequent weeks and months the stimulator may be required at less frequent intervals to maintain adequate analgesia. It is intended to be a lifelong device although long term data are currently lacking.

A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain
Timothy R Deer et al Pain Med 2020 Aug 1;21(8):1590-1603. doi: 10.1093/pm/pnaa030.
This systematic review gives a good overview of the current evidence in this field.
Long term data for the effectiveness of peripheral nerve stimulators in chronic pain are lacking at present.
Much of the published evidence supports its use in the treatment of intractable headache and pelvic disorders.
There is some Level II evidence, that peripheral nerve pain may be modestly improved by use of a peripheral nerve stimulator. Long term outcomes remain unknown.
1.Deer TR, Provenzano DA, Hanes M, et al. The Neurostimulation Appropriateness Consensus Committee (NACC) recommendations for infection prevention and management. Neuromodulation
2017;20(1):31–50.
Deer performed a double blind RCT of peripheral nerve stimulation and showed significant improvements in pain scores at three months compared to non-treated controls.
2. Paul Verrills 1, David Vivian, Bruce Mitchell, Adele Barnard Pain Med 2011 Sep;12(9):1395-405. doi: 10.1111/j.1526-4637.2011.01201.x. Epub 2011 Aug 3. Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature
A prospective observational study showing 72% of patients reduced their analgesic use after implantation and a follow up time of 1-23 months. The study showed significant reductions in pain scores.


Reference

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