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Article History

Received: 24 April 2023

Accepted: 6 November 2023

First Online: 25 November 2023

Declarations

:

: This clinical trial must be approved in advance by the Healthcare Ethics Committee of the DUH (Quironsalud Group) (<i>Comité de Ética, de investigación y del medicamento</i>). All the requirements of the Declaration of Helsinki, with the privacy and data protection law LOPD GDD of 03/2018 of December 5 and Regulation 201/679 of the European Parliament and of the Council, of 2016 April 27, will be met. Only the main investigator will have access to the data of the patients included in the study, and therefore she will sign a document for the correct use of this commitment {27} {29}.All patients will receive an information sheet explaining all details of the clinical trial and the implications of their individual participation in it. Written, informed consent to participate will be obtained from all participants {32}.As explained in the patient information document, since we currently have no scientific evidence to show that ACS therapy is effective for chronic radicular-type pain, all included patients, both experimental group and placebo group, receive PRF therapy on the DRG, which currently has sufficient scientific evidence to support its satisfactory results. The patient explained that this same therapy would still be offered even if he did not participate in the study. In this way, the placebo group does not suffer from therapeutic inferiority in terms of their current pathology, because the fact of participating in the study already allows them to undergo a treatment already endorsed as effective today.The main author’s only interest is to discover new treatments for refractory radicular pain and to advance new therapies for neuropathic pain. Once the study is finished, there is an intention on the part of the main author of its scientific dissemination in scientific journals, congresses, and meetings of expert {31a}.

: In terms of patient safety, the Department of Anaesthesiology, Resuscitation and Pain Treatment provides a civil liability policy to cover the procedures. The company Orthogen Lab Services GmbH also intends to cover the administration of the therapy within the clinical trial with its civil liability policy already used in previous clinical trials of 1 year of renewable duration year after year.

: There authors declare no competing interests.