Academic Journal
Efficacy of different spinal cord stimulation paradigms for the treatment of chronic neuropathic pain (PARS-trial): study protocol for a double-blinded, randomized, and placebo-controlled crossover trial
| Title: | Efficacy of different spinal cord stimulation paradigms for the treatment of chronic neuropathic pain (PARS-trial): study protocol for a double-blinded, randomized, and placebo-controlled crossover trial |
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| Authors: | Rezvan Ahmadi, Benito Campos, Mohammad Mehdi Hajiabadi, Colette Doerr-Harim, Solveig Tenckhoff, Dirk Rasche, Andreas Unterberg, Jan Vesper, Tom Bruckner, Volker Tronnier |
| Source: | Trials Trials, Vol 22, Iss 1, Pp 1-9 (2021) |
| Publisher Information: | Springer Science and Business Media LLC, 2021. |
| Publication Year: | 2021 |
| Subject Terms: | Adult, Male, Medicine (General), Neuropathic pain, Wireless stimulation, Study Protocol, Diagnostic Self Evaluation, 03 medical and health sciences, R5-920, 0302 clinical medicine, Double-Blind Method, Humans, Multicenter Studies as Topic, Pain Measurement, Randomized Controlled Trials as Topic, Spinal Cord Stimulation, Cross-Over Studies, Double-Blind Method [MeSH], Randomized controlled trial, Spinal Cord Stimulation/instrumentation [MeSH], Randomized Controlled Trials as Topic [MeSH], Chronic Pain/diagnosis [MeSH], Male [MeSH], Neuralgia/diagnosis [MeSH], Neuralgia/therapy [MeSH], Spinal Cord Stimulation/methods [MeSH], Quality of Life [MeSH], Diagnostic Self Evaluation [MeSH], Spinal cord stimulation, Female [MeSH], Adult [MeSH], Humans [MeSH], Treatment Outcome [MeSH], Chronic Pain/therapy [MeSH], Multicenter Studies as Topic [MeSH], Pain Measurement [MeSH], Implantable Neurostimulators/adverse effects [MeSH], Cross-Over Studies [MeSH], Spinal Cord Stimulation/adverse effects [MeSH], Wireless Technology/instrumentation [MeSH], 3. Good health, Implantable Neurostimulators, Treatment Outcome, Quality of Life, Neuralgia, Female, Chronic Pain, Wireless Technology |
| Description: | Background Spinal cord stimulation (SCS) is an effective method to treat neuropathic pain; however, it is challenging to compare different stimulation modalities in an individual patient, and thus, it is largely unknown which of the many available SCS modalities is most effective. Specifically, electrodes leading out through the skin would have to be consecutively connected to different, incompatible SCS devices and be tested over a time period of several weeks or even months. The risk of wound infections for such a study would be unacceptably high and blinding of the trial difficult. The PARS-trial seizes the capacity of a new type of wireless SCS device, which enables a blinded and systematic intra-patient comparison of different SCS modalities over extended time periods and without increasing wound infection rates. Methods The PARS-trial is designed as a double-blinded, randomized, and placebo-controlled multi-center crossover study. It will compare the clinical effectiveness of the three most relevant SCS paradigms in individual patients. The trial will recruit 60 patients suffering from intractable neuropathic pain of the lower extremities, who have been considered for SCS therapy and were already implanted with a wireless SCS device prior to study participation. Over a time period of 35 days, patients will be treated consecutively with three different SCS paradigms (“burst,” “1 kHz,” and “1.499 kHz”) and placebo stimulation. Each SCS paradigm will be applied for 5 days with a washout period of 70 h between stimulation cycles. The primary endpoint of the study is the level of pain self-assessment on the visual analogue scale after 5 days of SCS. Secondary, exploratory endpoints include self-assessment of pain quality (as determined by painDETECT questionnaire), quality of life (as determined by Quality of Life EQ-5D-5L questionnaire), anxiety perception (as determined by the Hospital Anxiety and Depression Scale), and physical restriction (as determined by the Oswestry Disability Index). Discussion Combining paresthesia-free SCS modalities with wireless SCS offers a unique opportunity for a blinded and systematic comparison of different SCS modalities in individual patients. This trial will advance our understanding of the clinical effectiveness of the most relevant SCS paradigms. Trial registration German Clinical Trials Register, DRKS00018929. Registered on 14 January 2020. |
| Document Type: | Article Other literature type |
| Language: | English |
| ISSN: | 1745-6215 |
| DOI: | 10.1186/s13063-020-05013-7 |
| Access URL: | https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-020-05013-7 https://pubmed.ncbi.nlm.nih.gov/33494781 https://doaj.org/article/c77aefd5ff084bb4ad184528b412adaf https://link.springer.com/content/pdf/10.1186/s13063-020-05013-7.pdf https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7830748 https://europepmc.org/article/PMC/PMC7830748 https://pubmed.ncbi.nlm.nih.gov/33494781/ https://link.springer.com/article/10.1186/s13063-020-05013-7 https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-05013-7 https://repository.publisso.de/resource/frl:6465490 |
| Rights: | CC BY |
| Accession Number: | edsair.doi.dedup.....e8d2e15a46fa89ec498babf7e381629b |
| Database: | OpenAIRE |
| ISSN: | 17456215 |
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| DOI: | 10.1186/s13063-020-05013-7 |