B rain connectivity-guided, Optimised theta burst transcranial magnetic stimulation to improve Central Pain Modulation in knee Osteoarthritis Pain (BoostCPM): protocol of a pilot randomised clinical trial in a secondary care setting in the UK.

Autor:	Drabek M; Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK.; Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.; Pain Centre Versus Arthritis, University of Nottingham, Nottingham, UK., Hodkinson D; Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK.; Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.; Pain Centre Versus Arthritis, University of Nottingham, Nottingham, UK., Horvath S; Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK., Millar B; Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.; Pain Centre Versus Arthritis, University of Nottingham, Nottingham, UK.; Academic Rheumatology, School of Medicine, University of Nottingham, Nottingham, UK., Pszczolkowski Parraguez S; Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK.; Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK., Tench CR; Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK., Tanasescu R; Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.; Clinical Neurology, Nottingham University Hospital Trusts, Nottingham, UK., Lankappa S; Adult Mental Health, Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK., Morriss R; Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK.; Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK., Walsh D; Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.; Pain Centre Versus Arthritis, University of Nottingham, Nottingham, UK.; Academic Rheumatology, School of Medicine, University of Nottingham, Nottingham, UK., Auer DP; Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK dorothee.auer@nottingham.ac.uk.; Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.; Pain Centre Versus Arthritis, University of Nottingham, Nottingham, UK.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 Oct 16; Vol. 13 (10), pp. e073378. Date of Electronic Publication: 2023 Oct 16.
DOI:	10.1136/bmjopen-2023-073378
Abstrakt:	Introduction: Chronic pain is a common health problem that is not efficiently managed by standard analgesic treatments. There is evidence that treatment resistance may result from maladaptive brain changes in areas that are fundamental to the perception of pain. Knee osteoarthritis is one of the most prevalent causes of chronic pain and commonly associated with negative affect. Chronic knee osteoarthritis pain is also associated with altered right anterior insula functional connectivity. We posit that reversal of these brain circuit alterations may be critical to alleviate chronic pain and associated negative affect, and that this can be achieved through non-invasive neuromodulation techniques. Despite growing interest in non-invasive neuromodulation for pain relief and proven efficacy in depression, results in chronic pain are mixed with limited high-quality evidence for clinical and mechanistic efficacy. Limitations include patient heterogeneity, imprecision of target selection, uncertain blinding and protocols that may deliver pulses at subclinical efficacy. Methods and Analysis: We hence developed an optimised treatment protocol of connectivity-guided intermittent theta-burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex with accelerated delivery on four consecutive days (allowing 4 days within the same week as protocol variation) with five daily treatment sessions that will be piloted in a sham-controlled design in 45 participants with chronic knee pain. This pilot study protocol will assess feasibility, tolerability and explore mechanistic efficacy through serial functional/structural magnetic resonance imaging (MRI) and quantitative sensory testing. Ethics and Dissemination: This pilot trial has been approved by the Ethics Committee Cornwall and Plymouth.Results of the pilot trial will be submitted to peer-reviewed journals, presented at research conferences and may be shared with participants and PPI/E advisors. Trial Registration Number: ISRCTN15404076. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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