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A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain.
Neuromodulation. 2013 Sep-Oct; 16(5):471-82; discussion 482.N

Abstract

OBJECTIVES

This multicenter prospective trial was conducted to evaluate the clinical performance of a new neurostimulation system designed to treat chronic pain through the electrical neuromodulation of the dorsal root ganglia (DRG) neurophysiologically associated with painful regions of the limbs and/or trunk.

MATERIALS AND METHODS

Thirty-two subjects were implanted with a novel neuromodulation device. Pain ratings during stimulation were followed up to six months and compared with baseline ratings. Subjects also completed two separate reversal periods in which stimulation was briefly stopped in order to establish the effects of the intervention.

RESULTS

At all assessments, more than half of subjects reported pain relief of 50% or better. At six months postimplant, average overall pain ratings were 58% lower than baseline (p < 0.001), and the proportions of subjects experiencing 50% or more reduction in pain specific to back, leg, and foot regions were 57%, 70%, and 89%, respectively. When stimulation was discontinued for a short time, pain returned to baseline levels. Discrete coverage of hard-to-treat areas was obtained across a variety of anatomical pain distributions. Paresthesia intensity remained stable over time and there was no significant difference in the paresthesia intensity perceived during different body postures/positions (standing up vs. lying down).

CONCLUSIONS

Results of this clinical trial demonstrate that neurostimulation of the DRG is a viable neuromodulatory technique for the treatment of chronic pain. Additionally, the capture of discrete painful areas such as the feet combined with stable paresthesia intensities across body positions suggest that this stimulation modality may allow more selective targeting of painful areas and reduce unwanted side-effects observed in traditional spinal cord stimulation (SCS).

Authors+Show Affiliations

Department of Anesthesiology, Sint Antonius, Nieuwegein, The Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

23668228

Citation

Liem, Liong, et al. "A Multicenter, Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Dorsal Root Ganglion Neurostimulator System in the Treatment of Chronic Pain." Neuromodulation : Journal of the International Neuromodulation Society, vol. 16, no. 5, 2013, pp. 471-82; discussion 482.
Liem L, Russo M, Huygen FJ, et al. A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. Neuromodulation. 2013;16(5):471-82; discussion 482.
Liem, L., Russo, M., Huygen, F. J., Van Buyten, J. P., Smet, I., Verrills, P., Cousins, M., Brooker, C., Levy, R., Deer, T., & Kramer, J. (2013). A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. Neuromodulation : Journal of the International Neuromodulation Society, 16(5), 471-82; discussion 482. https://doi.org/10.1111/ner.12072
Liem L, et al. A Multicenter, Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Dorsal Root Ganglion Neurostimulator System in the Treatment of Chronic Pain. Neuromodulation. 2013;16(5):471-82; discussion 482. PubMed PMID: 23668228.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. AU - Liem,Liong, AU - Russo,Marc, AU - Huygen,Frank J P M, AU - Van Buyten,Jean-Pierre, AU - Smet,Iris, AU - Verrills,Paul, AU - Cousins,Michael, AU - Brooker,Charles, AU - Levy,Robert, AU - Deer,Timothy, AU - Kramer,Jeffery, Y1 - 2013/05/13/ PY - 2013/02/08/received PY - 2013/03/26/revised PY - 2013/04/02/accepted PY - 2013/5/15/entrez PY - 2013/5/15/pubmed PY - 2014/10/30/medline KW - Chronic pain KW - dorsal root ganglion (DRG) KW - neuromodulation KW - spinal cord stimulation (SCS) KW - visual analog scale (VAS) SP - 471-82; discussion 482 JF - Neuromodulation : journal of the International Neuromodulation Society JO - Neuromodulation VL - 16 IS - 5 N2 - OBJECTIVES: This multicenter prospective trial was conducted to evaluate the clinical performance of a new neurostimulation system designed to treat chronic pain through the electrical neuromodulation of the dorsal root ganglia (DRG) neurophysiologically associated with painful regions of the limbs and/or trunk. MATERIALS AND METHODS: Thirty-two subjects were implanted with a novel neuromodulation device. Pain ratings during stimulation were followed up to six months and compared with baseline ratings. Subjects also completed two separate reversal periods in which stimulation was briefly stopped in order to establish the effects of the intervention. RESULTS: At all assessments, more than half of subjects reported pain relief of 50% or better. At six months postimplant, average overall pain ratings were 58% lower than baseline (p < 0.001), and the proportions of subjects experiencing 50% or more reduction in pain specific to back, leg, and foot regions were 57%, 70%, and 89%, respectively. When stimulation was discontinued for a short time, pain returned to baseline levels. Discrete coverage of hard-to-treat areas was obtained across a variety of anatomical pain distributions. Paresthesia intensity remained stable over time and there was no significant difference in the paresthesia intensity perceived during different body postures/positions (standing up vs. lying down). CONCLUSIONS: Results of this clinical trial demonstrate that neurostimulation of the DRG is a viable neuromodulatory technique for the treatment of chronic pain. Additionally, the capture of discrete painful areas such as the feet combined with stable paresthesia intensities across body positions suggest that this stimulation modality may allow more selective targeting of painful areas and reduce unwanted side-effects observed in traditional spinal cord stimulation (SCS). SN - 1525-1403 UR - https://www.unboundmedicine.com/medline/citation/23668228/A_multicenter_prospective_trial_to_assess_the_safety_and_performance_of_the_spinal_modulation_dorsal_root_ganglion_neurostimulator_system_in_the_treatment_of_chronic_pain_ L2 - https://doi.org/10.1111/ner.12072 DB - PRIME DP - Unbound Medicine ER -