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Artikel ; Online: First evidence of a biomarker-based dose-response relationship in chronic pain using physiological closed-loop spinal cord stimulation.

Muller, Leah / Pope, Jason / Verrills, Paul / Petersen, Erika / Kallewaard, Jan Willem / Gould, Ian / Karantonis, Dean M

Regional anesthesia and pain medicine

2024

Abstract: Background and objectives: In spinal cord stimulation (SCS) therapy, electricity is the medication delivered to the spinal cord for pain relief. In contrast to conventional medication where dose is determined by desired therapeutic plasma concentration, ...

Abstract	Background and objectives: In spinal cord stimulation (SCS) therapy, electricity is the medication delivered to the spinal cord for pain relief. In contrast to conventional medication where dose is determined by desired therapeutic plasma concentration, there is lack of equivalent means of determining dose delivery in SCS. In open-loop (OL) SCS, due to the dynamic nature of the epidural space, the activating electric field delivered is inconsistent at the level of the dorsal columns. Recent Food and Drug Administration guidance suggests accurate and consistent therapy delivered using physiologic closed-loop control (PCLC) devices can minimize underdosage or overdosage and enhance medical care. PCLC-based evoked compound action potential (ECAP)-controlled technology provides the ability to prescribe a precise stimulation dose unique to each patient, continuously measure neural activation, and objectively inform SCS therapy optimization. Methods: Neurophysiological indicator metrics of therapy dose, usage above neural activation threshold, and accuracy of SCS therapy were assessed for relationship with pain reduction in over 600 SCS patients. Results: Significant relationships between objective metrics and pain relief across the patient population are shown, including first evidence for a dose-response relationship in SCS. Conclusions: Higher dose, more time over ECAP threshold, and higher accuracy are associated with better outcomes across patients. There is potential to optimize individual patient outcomes based on unique objective measurable electrophysiological inputs.
Sprache	Englisch
Erscheinungsdatum	2024-03-19
Erscheinungsland	England
Dokumenttyp	Journal Article
ZDB-ID	1425299-5
ISSN	1532-8651 ; 1098-7339 ; 0146-521X
ISSN (online)	1532-8651
ISSN	1098-7339 ; 0146-521X
DOI	10.1136/rapm-2024-105346
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel: Treating Chronic, Intractable Pain with a Miniaturized Spinal Cord Stimulation System: 1-Year Outcomes from the AUS-nPower Study During the COVID-19 Pandemic.

Salmon, John / Bates, Daniel / Du Toit, Neels / Verrills, Paul / Yu, James / Taverner, Murray G / Mohabbati, Vahid / Green, Matthew / Heit, Gary / Levy, Robert / Staats, Peter / Kottalgi, Shilpa / Makous, James / Mitchell, Bruce

Journal of pain research

2024 Band 17, Seite(n) 293–304

Abstract: Purpose: Spinal cord stimulation (SCS) is a highly effective treatment for chronic neuropathic pain. Despite recent advances in technology, treatment gaps remain. A small SCS system with a miniaturized implantable pulse generator (micro-IPG; <1.5 cm: ... ...

Abstract	Purpose: Spinal cord stimulation (SCS) is a highly effective treatment for chronic neuropathic pain. Despite recent advances in technology, treatment gaps remain. A small SCS system with a miniaturized implantable pulse generator (micro-IPG; <1.5 cm Patients and methods: This was a prospective, multi-center, open-label, single-arm study to evaluate this SCS system, in the treatment of chronic, intractable leg and low-back pain. Consented subjects who passed screening continued on to the long-term phase of the study. One-year, patient-reported outcomes (PRO's) such as pain (Numeric Rating Scale, NRS), functional disability, quality of life, and mood were captured. Results: Twenty-six (26) evaluable subjects with permanent implants were included in this analysis. The average leg pain NRS score decreased from 6.8 ± 1.2 at baseline to 1.1 ± 1.2 at the end of the study (p < 0.001), while the average low-back pain NRS score decreased from 6.8 ± 1.2 to 1.5 ± 1.2 (p < 0.001). The responder rate (proportion with ≥50% pain relief) was 91% in the leg(s) and 82% in the low back. There were significant improvements in functional disability (Oswestry Disability Index) and in mood (Beck Depression Inventory), demonstrating a 46% and 62% improvement, respectively (p < 0.001). Eleven-point Likert scales demonstrated the wearable to be very comfortable and very easy to use. Conclusion: There were considerable challenges conducting a clinical study during the COVID-19 pandemic, such as missed study programming visits. Nevertheless, subjects had significant PRO improvements through 1-year. The small size of the implanted device, along with a proprietary waveform, may allow for improved SCS outcomes and a drop in incidence of IPG-pocket pain.
Sprache	Englisch
Erscheinungsdatum	2024-01-21
Erscheinungsland	New Zealand
Dokumenttyp	Case Reports ; Clinical Trial
ZDB-ID	2495284-9
ISSN	1178-7090
ISSN	1178-7090
DOI	10.2147/JPR.S436889
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: The impact of a regionally based translational cancer research collaborative in Australia using the FAIT methodology.

Paul, Christine L / Verrills, Nicole M / Ackland, Stephen / Scott, Rodney / Goode, Susan / Thomas, Ann / Lukeman, Sarah / Nielsen, Sarah / Weidenhofer, Judith / Lynam, James / Fradgley, Elizabeth A / Martin, Jarad / Greer, Peter / Smith, Stephen / Griffin, Cassandra / Avery-Kiejda, Kelly A / Zdenkowski, Nick / Searles, Andrew / Ramanathan, Shanthi

BMC health services research

2024 Band 24, Heft 1, Seite(n) 320

Abstract: Background: Translating research, achieving impact, and assessing impact are important aspirations for all research collaboratives but can prove challenging. The Hunter Cancer Research Alliance (HCRA) was funded from 2014 to 2021 to enhance capacity and ...

Abstract	Background: Translating research, achieving impact, and assessing impact are important aspirations for all research collaboratives but can prove challenging. The Hunter Cancer Research Alliance (HCRA) was funded from 2014 to 2021 to enhance capacity and productivity in cancer research in a regional centre in Australia. This study aimed to assess the impact and benefit of the HCRA to help inform future research investments of this type. Method: The Framework to Assess the Impact from Translational health research (FAIT) was selected as the preferred methodology. FAIT incorporates three validated methodologies for assessing impact: 1) Modified Payback; 2) Economic Analysis; and 3) Narrative overview and case studies. All three FAIT methods are underpinned by a Program Logic Model. Data were collected from HCRA and the University of Newcastle administrative records, directly from HCRA members, and website searches. Results: In addition to advancing knowledge and providing capacity building support to members via grants, fellowships, scholarships, training, events and targeted translation support, key impacts of HCRA-member research teams included: (i) the establishment of a regional biobank that has distributed over 13,600 samples and became largely self-sustaining; (ii) conservatively leveraging $43.8 M (s.a.$20.5 M - $160.5 M) in funding and support from the initial $9.7 M investment; (iii) contributing to clinical practice guidelines and securing a patent for identification of stem cells for endometrial cell regeneration; (iv) shifting the treatment paradigm for all tumour types that rely on nerve cell innervation, (v) development and implementation of the world's first real-time patient treatment verification system (Watchdog); (vi) inventing the effective 'EAT' psychological intervention to improve nutrition and outcomes in people experiencing radiotherapy for head and neck cancer; (vi) developing effective interventions to reduce smoking rates among priority groups, currently being rolled out to disadvantaged populations in NSW; and (vii) establishing a Consumer Advisory Panel and Consumer Engagement Committee to increase consumer involvement in research. Conclusion: Using FAIT methodology, we have demonstrated the significant impact and downstream benefits that can be achieved by the provision of infrastructure-type funding to regional and rural research collaboratives to help address inequities in research activity and health outcomes and demonstrates a positive return on investment.
Mesh-Begriff(e)	Humans ; Program Evaluation/methods ; Translational Research, Biomedical ; Australia ; Translational Science, Biomedical ; Neoplasms/therapy
Sprache	Englisch
Erscheinungsdatum	2024-03-11
Erscheinungsland	England
Dokumenttyp	Journal Article
ZDB-ID	2050434-2
ISSN	1472-6963 ; 1472-6963
ISSN (online)	1472-6963
ISSN	1472-6963
DOI	10.1186/s12913-024-10680-2
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel: Chronic Abdominal Discomfort Syndrome (CADS): Defining and Discussing a Novel Diagnosis.

Gupta, Mayank / Patil, Anand S / Chitneni, Ahish / Schatman, Michael E / Kalia, Hemant / Deer, Timothy R / Sayed, Dawood / Soin, Amol / Baranidharan, Ganesan / Staats, Peter / Kapural, Leonardo / Attaluri, Phani Ashok / Verrills, Paul / Diwan, Sudhir / Levin, Danielle / Halder, Nimisha / Abd-Elsayed, Alaa A

Journal of pain research

2024 Band 17, Seite(n) 975–979

Abstract: In this article, we propose a new diagnostic paradigm known as Chronic Abdominal Discomfort Syndrome (CADS). Patient's presentation centers around chronic abdominal pain not explained by acute pathology with or without accompanying dyspepsia, bloating, ... ...

Abstract	In this article, we propose a new diagnostic paradigm known as Chronic Abdominal Discomfort Syndrome (CADS). Patient's presentation centers around chronic abdominal pain not explained by acute pathology with or without accompanying dyspepsia, bloating, nausea and vomiting among other symptoms. The pathophysiology is noted to be neurogenic, possibly stemming from visceral sympathetic nerves or abdominal wall afferent nerves. Diagnosis is supported by signs or symptoms traversing clinical, diagnostic and functional criteria. Included is a tool which can assist clinicians in diagnosing patients with CADS per those domains. We hope to facilitate primary care physicians' and gastroenterologists' utilization of our criteria to provide guidance for selecting which patients may benefit from further interventions or evaluation by a pain physician. The pain physician may then offer interventions to provide the patient with relief.
Sprache	Englisch
Erscheinungsdatum	2024-03-11
Erscheinungsland	New Zealand
Dokumenttyp	Journal Article
ZDB-ID	2495284-9
ISSN	1178-7090
ISSN	1178-7090
DOI	10.2147/JPR.S450008
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Clinical Longevity of 106,462 Rechargeable and Primary Cell Spinal Cord Stimulators: Real World Study in the Medicare Population.

Deer, Timothy R / Pope, Jason E / Falowski, Steven M / Pilitsis, Julie G / Hunter, Corey W / Burton, Allen W / Connolly, Allison T / Verrills, Paul

Neuromodulation : journal of the International Neuromodulation Society

2022

Abstract: Introduction: Spinal cord stimulators (SCS) are available with either primary cell (PC) or rechargeable cell (RC) batteries. Although RC systems are proposed to have a battery longevity upward of nine years, in comparison with four years for PC systems, ...

Abstract	Introduction: Spinal cord stimulators (SCS) are available with either primary cell (PC) or rechargeable cell (RC) batteries. Although RC systems are proposed to have a battery longevity upward of nine years, in comparison with four years for PC systems, there are few studies of longevity of SCS in the real world. Materials and methods: This was an observational, nonrandomized, retrospective study of Medicare beneficiaries who received neurostimulator implants in the outpatient hospital. This study used Medicare fee-for-service claims data from 2013 to 2020. The clinical longevity of the implantable pulse generator (IPG), defined as the duration from implant until removal for any reason, was compared between PC and RC devices. Life distribution analysis was used to approximate device lifespan. The secondary analysis separated removals into explant or replacements. The statistics were adjusted for relevant clinical covariates. Results: A total of 25,856 PC and 79,606 RC systems were included in the study. At seven years after implant, 53.8% of PC IPGs and 55.0% of RC IPGs remained in use. The life distribution modeling analysis projected a median lifespan of 8.2 years for PC and 9.0 years for RC devices. The rate of explant was lower for PC devices (19.2%) than for RC devices (22.0%, hazard ratio (HR) = 0.96, p = 0.082), whereas the rate of replacements was higher for PC devices (33.7%) than for RC devices (29.5%, HR = 1.31, p < 0.001). An analysis of the battery type used in device replacements showed an increasing adoption of PC devices over time. Conclusions: This large, retrospective, real-world analysis of Medicare claims data demonstrated that the clinical longevity of neurostimulator devices is similar for PC and RC batteries. In the past, clinicians may have defaulted to RC devices based on the assumption that they provided extended battery life. Considering this longevity data, clinicians should now consider the choice between PC and RC devices based on other individual factors pertinent to the patient experience and not on purported longevity claims.
Sprache	Englisch
Erscheinungsdatum	2022-06-08
Erscheinungsland	United States
Dokumenttyp	Journal Article
ZDB-ID	1500372-3
ISSN	1525-1403 ; 1094-7159
ISSN (online)	1525-1403
ISSN	1094-7159
DOI	10.1016/j.neurom.2022.04.046
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Re: Thanks But No Thanks.

FitzGerald, James J / Lubenow, Timothy J / Verrills, Paul

Pain medicine (Malden, Mass.)

2017 Band 18, Heft 9, Seite(n) 1820

Sprache	Englisch
Erscheinungsdatum	2017-09-19
Erscheinungsland	England
Dokumenttyp	Letter ; Comment
ZDB-ID	2015903-1
ISSN	1526-4637 ; 1526-2375
ISSN (online)	1526-4637
ISSN	1526-2375
DOI	10.1093/pm/pnx202
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Peripheral Nerve Stimulation for Back Pain.

Verrills, Paul / Russo, Marc

Progress in neurological surgery

2015 Band 29, Seite(n) 127–138

Abstract: Peripheral nerve stimulation (PNS) generally refers to stimulation of a named nerve via direct placement of a lead next to the nerve either via a percutaneous or open approach; in peripheral nerve field stimulation (PNFS), leads are subcutaneously placed ...

Abstract	Peripheral nerve stimulation (PNS) generally refers to stimulation of a named nerve via direct placement of a lead next to the nerve either via a percutaneous or open approach; in peripheral nerve field stimulation (PNFS), leads are subcutaneously placed to stimulate the region of affected nerves, cutaneous afferents, or the dermatomal distribution of the nerves which converge back to the spinal cord. Recently, there has been a renewed interest in using the PNS approach for many otherwise refractory pain conditions; however, PNFS appears to be more effective for the management of low back pain and therefore more attractive. Here we discuss procedural details of PNFS trial and implant, and provide scientific and clinical rationale for placing PNFS electrodes at a certain depth under the skin. We also summarize results of published studies on use of PNFS in the management of low back pain and list the criteria that are used for proper patient selection. Our experience and the published studies provide evidence that PNFS is a safe and well-tolerated pain control option for intractable pain conditions, including chronic low back pain. Notably, achieving efficacious pain relief relies on correct patient selection and the optimal placement of the leads, ensuring, in particular, a lead depth of 10-12 mm from the surface to maximize the target sensation (mediated by fast-adapting Aβ fibers) of PNFS, which is believed to be most effective for the pain relief.
Mesh-Begriff(e)	Back Pain/diagnosis ; Back Pain/surgery ; Electric Stimulation Therapy/instrumentation ; Electric Stimulation Therapy/methods ; Electrodes, Implanted ; Humans ; Implantable Neurostimulators ; Pain Management/instrumentation ; Pain Management/methods ; Peripheral Nerves/physiology ; Peripheral Nerves/surgery
Sprache	Englisch
Erscheinungsdatum	2015
Erscheinungsland	Switzerland
Dokumenttyp	Journal Article ; Review
ISSN	1662-3924 ; 0079-6492
ISSN (online)	1662-3924
ISSN	0079-6492
DOI	10.1159/000434666
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Dorsal Root Ganglion Stimulation Is Paresthesia-Independent: A Retrospective Study.

Verrills, Paul / Mitchell, Bruce / Vivian, David / Cusack, William / Kramer, Jeffery

Neuromodulation : journal of the International Neuromodulation Society

2019 Band 22, Heft 8, Seite(n) 937–942

Abstract: Introduction: Neuromodulation is an important tool for achieving pain relief in otherwise-intractable neuropathic pain conditions. Dorsal root ganglion (DRG) stimulation, in which primary sensory neurons are stimulated prior to their entry into the ... ...

Abstract	Introduction: Neuromodulation is an important tool for achieving pain relief in otherwise-intractable neuropathic pain conditions. Dorsal root ganglion (DRG) stimulation, in which primary sensory neurons are stimulated prior to their entry into the spinal canal, provides treatment with high levels of dermatomal specificity and can provide advantages compared to conventional spinal cord stimulation. Although DRG stimulation can produce perceptible paresthesias, many patients operate their systems at subthreshold amplitudes that do not elicit this sensation. Pain relief both with and without paresthesia was investigated in this retrospective analysis. Materials and methods: A retrospective review of all qualifying permanent DRG stimulation systems at a single center over more than a three-year period was completed. Pain (0-10 numeric rating scale) was assessed at baseline, at the end of the trial, and after three, six, and twelve months of treatment. Patients were categorized based on their usage of the stimulator at amplitudes that either did or did not produce paresthesias. Results: Of the 39 patients, 34 (87%) reported having no-paresthesias at any of the follow-up visits. Average pain relief was 73.9% after the trial period and 63.1% after 12 months of treatment. The responder rate (50% or better pain relief) after three months of treatment was more than 80%. Exploratory subgroup analyses showed that similar degrees of pain relief were achieved in numerous body regions and with various pain etiologies. The five patients who reported paresthesias during treatment had pain relief similar to those of the group that did not experience paresthesias. Discussion: Clinically significant and sustained pain relief over more than a period of 12 months was achieved with DRG stimulation programmed at amplitudes below the perceptual level. Thus, the reported analgesia was paresthesia-independent. That good clinical outcomes were observed independent of the generation of paresthesia in DRG stimulation suggests several mechanisms of action, including the inhibition of supraspinal regions involved in somatic paresthesia sensation. The retrospective results presented here posit that future prospective study of DRG stimulation delivered at below the threshold of perceptible paresthesias is warranted.
Mesh-Begriff(e)	Adult ; Causalgia/therapy ; Female ; Ganglia, Spinal ; Humans ; Male ; Middle Aged ; Pain Management/adverse effects ; Pain Management/methods ; Pain Measurement ; Pain Perception ; Paresthesia/epidemiology ; Paresthesia/etiology ; Reflex Sympathetic Dystrophy/therapy ; Retrospective Studies ; Spinal Cord Stimulation/adverse effects ; Spinal Cord Stimulation/methods ; Treatment Outcome
Sprache	Englisch
Erscheinungsdatum	2019-01-30
Erscheinungsland	United States
Dokumenttyp	Comparative Study ; Journal Article
ZDB-ID	1500372-3
ISSN	1525-1403 ; 1094-7159
ISSN (online)	1525-1403
ISSN	1094-7159
DOI	10.1111/ner.12921
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel: Best Practices from the American Society of Pain and Neuroscience (ASPN) for Clinical Research During a Pandemic or Emergency.

Petersen, Erika A / Deer, Timothy R / Bojanic, Stana / Sankary, Lauren R / Strand, Natalie H / Al Kaisy, Adnan / Huygen, Frank / Sayed, Dawood / Steegers, Monique / Verrills, Paul / Schatman, Michael E

Journal of pain research

2023 Band 16, Seite(n) 327–339

Abstract: The COVID-19 pandemic caught many areas of medicine in a state of unpreparedness for conducting research and completing ongoing projects during a global crisis, including the field of pain medicine. Waves of infection led to a disjointed ability to ... ...

Abstract	The COVID-19 pandemic caught many areas of medicine in a state of unpreparedness for conducting research and completing ongoing projects during a global crisis, including the field of pain medicine. Waves of infection led to a disjointed ability to provide care and conduct clinical research. The American Society of Pain and Neuroscience (ASPN) Research Group has created guidance for pragmatic and ethical considerations for research during future emergency or disaster situations. This analysis uses governmental guidance, scientific best practices, and expert opinion to address procedure-based or device-based clinical trials during such times. Current literature offers limited recommendations on this important issue, and the findings of this group fill a void for protocols to improve patient safety and efficacy, especially as we anticipate the impact of future disasters and spreading global infectious diseases. We recommend local adaptations to best practices and innovations to enable continued research while respecting the stressors to the research subjects, investigator teams, health-care systems, and to local infrastructure.
Sprache	Englisch
Erscheinungsdatum	2023-02-01
Erscheinungsland	New Zealand
Dokumenttyp	Journal Article
ZDB-ID	2495284-9
ISSN	1178-7090
ISSN	1178-7090
DOI	10.2147/JPR.S393539
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: 10 kHz spinal cord stimulation for chronic upper limb and neck pain: Australian experience.

Verrills, Paul / Salmon, John / Russo, Marc / Gliner, Bradford / Barnard, Adele / Caraway, David

European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society

2020 Band 29, Heft 11, Seite(n) 2786–2794

Abstract: Purpose: Intractable upper limb and neck pain has traditionally been a challenging pain condition to treat, with conventional spinal cord stimulation (SCS) often inducing positional variation in paraesthesia and/or inadequate coverage of axial neck pain. ...

Abstract	Purpose: Intractable upper limb and neck pain has traditionally been a challenging pain condition to treat, with conventional spinal cord stimulation (SCS) often inducing positional variation in paraesthesia and/or inadequate coverage of axial neck pain. The purpose of this Australian multi-centre prospective, clinical trial was to assess the safety and effectiveness of paraesthesia-independent 10 kHz SCS for the treatment of upper limb and neck pain. Methods: Subjects with chronic, intractable neck and/or upper limb pain of ≥ 5 cm (on a 0-10-cm visual analogue scale) were enrolled (ACTRN12614000153617) following human research ethics committee approval. Subjects were implanted with two epidural leads spanning C2-C6 vertebral bodies. Subjects with successful trial stimulation were implanted with a Senza Results: Overall, 31/38 (82.6%) subjects reported a successful 10 kHz SCS trial and proceeded to a permanent implant. Twenty-three of 30 subjects (76.7%) met the PEA. Subjects reported a reduction in neck pain and upper limb pain from baseline at the PEA (8.1 ± 0.2 cm vs. 2.9 ± 0.5 cm, 7.3 ± 0.3 cm vs. 2.5 ± 0.5 cm, respectively, p ≤ 0.0001). Disability, as measured by pain disability index score, decreased from 42.6 ± 2.6 at baseline to 22.7 ± 3.2 at PEA. Results were maintained 12 months post-implant. No neurological deficits, nor reports of paraesthesia, were observed. Conclusions: Stable, long-term results demonstrated that 10 kHz SCS is a promising therapy option for intractable chronic upper limb and neck pain.
Mesh-Begriff(e)	Australia ; Chronic Pain/therapy ; Humans ; Neck Pain/therapy ; Pain Management ; Prospective Studies ; Spinal Cord ; Spinal Cord Stimulation ; Treatment Outcome ; Upper Extremity
Sprache	Englisch
Erscheinungsdatum	2020-06-30
Erscheinungsland	Germany
Dokumenttyp	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1115375-1
ISSN	1432-0932 ; 0940-6719
ISSN (online)	1432-0932
ISSN	0940-6719
DOI	10.1007/s00586-020-06480-x
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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