Trigeminal Neuralgia
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This document summarizes a study on using low-intensity, low-frequency ultrasound to treat 15 patients with trigeminal neuralgia. 73% of patients experienced relief from most or all of their pain. The ultrasound was delivered via a device placed against bony areas of the face to target the trigeminal nerve root entry zone. This novel non-invasive approach showed potential for neuroregeneration and long-term pain relief in refractory trigeminal neuralgia patients. However, pain recurred in some patients, possibly due to disease progression beyond the treatment scope.
![A sound solution for Trigeminal Neuralgia
Our primary preliminary experience with 15 cases treated at Sheba Medical Center
Dr Haim- Moshe Adahan, Head of the Pain Rehabilitation Unit of Sheba Medical Center
Dr Yaacov Ezra, Staff Neurology & Pain Divisions, Hadassah Hospital of Jerusalem
Dr Itschak Siev-Ner, Head of the Orthopedic Rehabilitation Division, Sheba Medical Center
Introduction Trigeminal Neuralgia Patients Outcome
Trigeminal neuralgia (TN) is one of the most severe and progressive
Temporary
forms of chronic neuropathic pain. The latest scientific work has TN
n Descriptor
No response <75% >75% Complete relief and
refractory
Stage or pain response response relief
shown that the likely anatomic cause of the TN is a highly reversible recurrence
Intermittent pain
tiny CNS lesion at the root entry zone of the trigeminal nerve A 1 crises 1
measuring less than 0.5 cm3. No pain, but need
for continuous
The presence of a discrete, highly eloquent and highly reversible B 1 meds, With
1
problematic side
CNS lesion presents a unique opportunity to test and measure the effects
Neuroregenerative potential of therapeutic modalities that can be C 2 Pain crisis despite
2
continuous meds
effectively delivered to the site of this pathology. Neuroregeneration
refers to the regrowth or repair of nervous tissues or cell.
Daily chronic
pain despite 1
D 11 continuous meds Moderate transient
2 6 2
Ultrasound delivered to injured nerves Motor root of trigeminal nerve
Sensory root of trigeminal nerve
With problematic pain aggravation at
site of dental implant
side effects
has been shown in animal studiesi ii iii iv v,
Summary 15 6.67% 13% 60% 20%
to have neuroregenerative capacities and
has also been associated with improved 73% of patients, most with severe disabling refrctory pain,
remyelination in human carpal tunnel got relived of most or all of their pain
vi
syndrome in 1 RCT . Until the advent
of readily clinically applicable surface Discussion
acoustic ultrasound technology, there was
This novel approach of delivering LILF ultrasound allows for longer
no clinically available ultrasound device
and more effective treatments. The Surface Acoustic Waves,
that could safely extend its therapeutic
unlike traditional ultrasound, are characterized by elliptical particle
effect for a prolonged period intra-cranially where the lesion of
movement travelling with great efficiency across bony surfacesvii.
the trigeminal nerve is located.
When applied to a bony surface, such as the forehead, the LILF/
SAW will travel and reach the entire surface of the skull and be
Methods effectively and efficiently transmitted via the CSF to the CNS
15 TN patients were treated with a Low Intensity, Low Frequency, structures juxtaposed against the bony structures. Hence, the root
Surface Acoustic Wave (LILF/SAW) device (PainShield - entry zone of the trigeminal nerve as well as the entire length of all
NanoVibronix Ltd. Nesher, Israel) [Fig 1]. Patients were instructed its branches are exposed to LILF/SAW which also travel along the
to use the device daily, overnight and remove it upon wakening. bony surface inside the cranial nerve foramina.
The device was programmed to work in cycles of 30 minutes on
The recurrence of pain in some patients, may be subsequent to
and 30 minutes off, for a total of 8 hours of intermittent treatment.
the progress of the demyelinating illness deeper in brain or that
If tolerable, the patient was asked to apply the PainShield actuator
the disease itself progressed beyond the capacity of our treatment
so that it abuts next to a bony prominence in the painful region;
modality to stop it.
such as the zygomatic arch in V2 pain [Fig 2] or the lower mandible
area in V3 pain. In some cases where the allodynia did not permit In addition to the hypothesized neuroregenerative effects of
wearing the patch on the painful zone, the actuator was applied on the LILF/SAW, it may also bring the added advantage of a wide
the forehead. surface Phonophoresis effect and possibly a mechanical washout
of accumulated pro-algesic substances in the nerve itself as well
as the facial soft tissues. This would be caused by the mechanical
effect of a 2 micron unidirectional mechanical pressure wave
traveling through these tissues at 90kHz. In some of the cases
described in this report, the Phonophoretic effect inherent to
ultrasound also became evident when PainShield treatment was
combined with compounded topical medicine cr竪mes containing
ketamine, and various anti-epileptic drugs amongst othersviii.
Conclusion
The results obtained in this open label series definitely point to
Fig 1 PainShield & treatment patch Fig 2 - Patient wearing
the PainShield device the need to further research this treatment modality in a larger
scale RCT. Further research evaluating the benefit of combining
Results the Phonophoretic effect of the LILF/SAW with topical ketamine
73 % of the subjects experienced complete or near complete solutions should also be considered in light of a recent RCT
relief. In nearly all cases, there was a delay of 1-2 weeks before confirming the benefit of topical ketamine in neuropathic painix.
the onset of relief followed by a gradual improvement over the This technology is able to deliver LILF/SAW to the entire outer
following 2-6 weeks. Most patients had reached a plateau in surface of the brain and brainstem and, in some cases, to certain
improvement after 2 months of use. Stopping the treatment led to locations of the spinal cord by using the CSF as a bridging
partial recurrence in some patients. 3 out of the four MS patients ultrasound conducting medium. There are no lack of potentially
suffered pain recurrence despite continued PainShield use; All 4 reversible pathologies in those anatomical locations in need of a
of our MS subjects suffered from a progressive form of MS. treatment with neuroregenerative potential.
References
i Low-intensity pulsed ultrasound accelerates the regeneration of the sciatic nerve after neurotomy in rats. Crisci v Low-intensity ultrasound for regeneration of injured peripheral nerve. Zhou W., Chen W., Zhou K., Wang Z.
A.R., Ferreira A.L. Ultrasound in Med. & Biol., 2002; 28(10):13351341 Neural regeneration research, 2006; 1(7)
ii The effects of low-intensity ultrasound on peripheral nerve regeneration in Poly(DL-lactic acid-co-glycolic acid) vi Ultrasound treatment for treating the carpal tunnel syndrome: randomised sham controlled trial. Ebenbichler
G.B., Resch K.L., Nicolakis P., Wiesinger G.F., Uhl F., Ghanem A.-H., Fialka V. BMJ, 1998; 316:731735
conduits seeded with Schwann cells. Chang C.-J., Hsu S.-H. Ultrasound in Med. & Biol., 2004; 30( 8):1079-
1084 vii Surface Acoustic Wave Devices for mobile and wireless communications. C.K.Campbell. Dep. of electrical eng.,
McMaster Un., Hamilton, Canada, 1998
iii Ultrasound Accelerates Functional Recovery after Peripheral Nerve Damage. Mourad P.D., Lazar D.A., Curra viii The Use of Sonophoresis in the Administration of Drugs Throughout the Skin. Jos辿 Juan Escobar-Ch叩vez, Dalia
F.P., Mohr B.C., Andrus K.C., Avellino A.M., McNutt L.D., Crum L.A., Kliot M. Neurosurgery, 2001; 48(5):1136- Bonilla-Mart鱈nez, Martha Ang辿lica Villegas-Gonz叩lez, Isabel, Marlen Rodr鱈guez-Cruz, Clara Luisa Dom鱈nguez-
1140 DelgadoJ Pharm Pharmaceut Sci 12 (1): 88 - 115, 2009.
iv Ultrasound therapy facilitates the recovery of the acute pressure-induced conduction block of the median nerve ix Reduction of allodynia in patients with complex regional pain syndrome: A double-blind placebo-controlled
in rabbits. Paik N.-J., Cho S.-H., Han T.R., Muscle Nerve, 2002; 26: 356361 trial of topical ketamine. Philip M. Finch, Lone Knudsen, Peter D. Drummond. PAIN_ 146 (2009) 1825](https://image.slidesharecdn.com/nanovibronix-treatmentfortrigeminalneuralgia1-110919055207-phpapp02/85/Trigeminal-Neuralgia-1-320.jpg)
Trigeminal Neuralgia
- 1. A sound solution for Trigeminal Neuralgia Our primary preliminary experience with 15 cases treated at Sheba Medical Center Dr Haim- Moshe Adahan, Head of the Pain Rehabilitation Unit of Sheba Medical Center Dr Yaacov Ezra, Staff Neurology & Pain Divisions, Hadassah Hospital of Jerusalem Dr Itschak Siev-Ner, Head of the Orthopedic Rehabilitation Division, Sheba Medical Center Introduction Trigeminal Neuralgia Patients Outcome Trigeminal neuralgia (TN) is one of the most severe and progressive Temporary forms of chronic neuropathic pain. The latest scientific work has TN n Descriptor No response <75% >75% Complete relief and refractory Stage or pain response response relief shown that the likely anatomic cause of the TN is a highly reversible recurrence Intermittent pain tiny CNS lesion at the root entry zone of the trigeminal nerve A 1 crises 1 measuring less than 0.5 cm3. No pain, but need for continuous The presence of a discrete, highly eloquent and highly reversible B 1 meds, With 1 problematic side CNS lesion presents a unique opportunity to test and measure the effects Neuroregenerative potential of therapeutic modalities that can be C 2 Pain crisis despite 2 continuous meds effectively delivered to the site of this pathology. Neuroregeneration refers to the regrowth or repair of nervous tissues or cell. Daily chronic pain despite 1 D 11 continuous meds Moderate transient 2 6 2 Ultrasound delivered to injured nerves Motor root of trigeminal nerve Sensory root of trigeminal nerve With problematic pain aggravation at site of dental implant side effects has been shown in animal studiesi ii iii iv v, Summary 15 6.67% 13% 60% 20% to have neuroregenerative capacities and has also been associated with improved 73% of patients, most with severe disabling refrctory pain, remyelination in human carpal tunnel got relived of most or all of their pain vi syndrome in 1 RCT . Until the advent of readily clinically applicable surface Discussion acoustic ultrasound technology, there was This novel approach of delivering LILF ultrasound allows for longer no clinically available ultrasound device and more effective treatments. The Surface Acoustic Waves, that could safely extend its therapeutic unlike traditional ultrasound, are characterized by elliptical particle effect for a prolonged period intra-cranially where the lesion of movement travelling with great efficiency across bony surfacesvii. the trigeminal nerve is located. When applied to a bony surface, such as the forehead, the LILF/ SAW will travel and reach the entire surface of the skull and be Methods effectively and efficiently transmitted via the CSF to the CNS 15 TN patients were treated with a Low Intensity, Low Frequency, structures juxtaposed against the bony structures. Hence, the root Surface Acoustic Wave (LILF/SAW) device (PainShield - entry zone of the trigeminal nerve as well as the entire length of all NanoVibronix Ltd. Nesher, Israel) [Fig 1]. Patients were instructed its branches are exposed to LILF/SAW which also travel along the to use the device daily, overnight and remove it upon wakening. bony surface inside the cranial nerve foramina. The device was programmed to work in cycles of 30 minutes on The recurrence of pain in some patients, may be subsequent to and 30 minutes off, for a total of 8 hours of intermittent treatment. the progress of the demyelinating illness deeper in brain or that If tolerable, the patient was asked to apply the PainShield actuator the disease itself progressed beyond the capacity of our treatment so that it abuts next to a bony prominence in the painful region; modality to stop it. such as the zygomatic arch in V2 pain [Fig 2] or the lower mandible area in V3 pain. In some cases where the allodynia did not permit In addition to the hypothesized neuroregenerative effects of wearing the patch on the painful zone, the actuator was applied on the LILF/SAW, it may also bring the added advantage of a wide the forehead. surface Phonophoresis effect and possibly a mechanical washout of accumulated pro-algesic substances in the nerve itself as well as the facial soft tissues. This would be caused by the mechanical effect of a 2 micron unidirectional mechanical pressure wave traveling through these tissues at 90kHz. In some of the cases described in this report, the Phonophoretic effect inherent to ultrasound also became evident when PainShield treatment was combined with compounded topical medicine cr竪mes containing ketamine, and various anti-epileptic drugs amongst othersviii. Conclusion The results obtained in this open label series definitely point to Fig 1 PainShield & treatment patch Fig 2 - Patient wearing the PainShield device the need to further research this treatment modality in a larger scale RCT. Further research evaluating the benefit of combining Results the Phonophoretic effect of the LILF/SAW with topical ketamine 73 % of the subjects experienced complete or near complete solutions should also be considered in light of a recent RCT relief. In nearly all cases, there was a delay of 1-2 weeks before confirming the benefit of topical ketamine in neuropathic painix. the onset of relief followed by a gradual improvement over the This technology is able to deliver LILF/SAW to the entire outer following 2-6 weeks. Most patients had reached a plateau in surface of the brain and brainstem and, in some cases, to certain improvement after 2 months of use. Stopping the treatment led to locations of the spinal cord by using the CSF as a bridging partial recurrence in some patients. 3 out of the four MS patients ultrasound conducting medium. There are no lack of potentially suffered pain recurrence despite continued PainShield use; All 4 reversible pathologies in those anatomical locations in need of a of our MS subjects suffered from a progressive form of MS. treatment with neuroregenerative potential. References i Low-intensity pulsed ultrasound accelerates the regeneration of the sciatic nerve after neurotomy in rats. Crisci v Low-intensity ultrasound for regeneration of injured peripheral nerve. Zhou W., Chen W., Zhou K., Wang Z. A.R., Ferreira A.L. Ultrasound in Med. & Biol., 2002; 28(10):13351341 Neural regeneration research, 2006; 1(7) ii The effects of low-intensity ultrasound on peripheral nerve regeneration in Poly(DL-lactic acid-co-glycolic acid) vi Ultrasound treatment for treating the carpal tunnel syndrome: randomised sham controlled trial. Ebenbichler G.B., Resch K.L., Nicolakis P., Wiesinger G.F., Uhl F., Ghanem A.-H., Fialka V. BMJ, 1998; 316:731735 conduits seeded with Schwann cells. Chang C.-J., Hsu S.-H. Ultrasound in Med. & Biol., 2004; 30( 8):1079- 1084 vii Surface Acoustic Wave Devices for mobile and wireless communications. C.K.Campbell. Dep. of electrical eng., McMaster Un., Hamilton, Canada, 1998 iii Ultrasound Accelerates Functional Recovery after Peripheral Nerve Damage. Mourad P.D., Lazar D.A., Curra viii The Use of Sonophoresis in the Administration of Drugs Throughout the Skin. Jos辿 Juan Escobar-Ch叩vez, Dalia F.P., Mohr B.C., Andrus K.C., Avellino A.M., McNutt L.D., Crum L.A., Kliot M. Neurosurgery, 2001; 48(5):1136- Bonilla-Mart鱈nez, Martha Ang辿lica Villegas-Gonz叩lez, Isabel, Marlen Rodr鱈guez-Cruz, Clara Luisa Dom鱈nguez- 1140 DelgadoJ Pharm Pharmaceut Sci 12 (1): 88 - 115, 2009. iv Ultrasound therapy facilitates the recovery of the acute pressure-induced conduction block of the median nerve ix Reduction of allodynia in patients with complex regional pain syndrome: A double-blind placebo-controlled in rabbits. Paik N.-J., Cho S.-H., Han T.R., Muscle Nerve, 2002; 26: 356361 trial of topical ketamine. Philip M. Finch, Lone Knudsen, Peter D. Drummond. PAIN_ 146 (2009) 1825