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Brain 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

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 mos...

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Autores principales: Drabek, Marianne, Hodkinson, Duncan, Horvath, Suzanne, Millar, Bonnie, Pszczolkowski Parraguez, Stefan, Tench, Christopher R, Tanasescu, Radu, Lankappa, Sudheer, Morriss, Richard, Walsh, David, Auer, Dorothee P
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10582853/
https://www.ncbi.nlm.nih.gov/pubmed/37844981
http://dx.doi.org/10.1136/bmjopen-2023-073378
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author Drabek, Marianne
Hodkinson, Duncan
Horvath, Suzanne
Millar, Bonnie
Pszczolkowski Parraguez, Stefan
Tench, Christopher R
Tanasescu, Radu
Lankappa, Sudheer
Morriss, Richard
Walsh, David
Auer, Dorothee P
author_facet Drabek, Marianne
Hodkinson, Duncan
Horvath, Suzanne
Millar, Bonnie
Pszczolkowski Parraguez, Stefan
Tench, Christopher R
Tanasescu, Radu
Lankappa, Sudheer
Morriss, Richard
Walsh, David
Auer, Dorothee P
author_sort Drabek, Marianne
collection PubMed
description 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.
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spelling pubmed-105828532023-10-19 Brain 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 Drabek, Marianne Hodkinson, Duncan Horvath, Suzanne Millar, Bonnie Pszczolkowski Parraguez, Stefan Tench, Christopher R Tanasescu, Radu Lankappa, Sudheer Morriss, Richard Walsh, David Auer, Dorothee P BMJ Open Pharmacology and Therapeutics 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. BMJ Publishing Group 2023-10-16 /pmc/articles/PMC10582853/ /pubmed/37844981 http://dx.doi.org/10.1136/bmjopen-2023-073378 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Pharmacology and Therapeutics
Drabek, Marianne
Hodkinson, Duncan
Horvath, Suzanne
Millar, Bonnie
Pszczolkowski Parraguez, Stefan
Tench, Christopher R
Tanasescu, Radu
Lankappa, Sudheer
Morriss, Richard
Walsh, David
Auer, Dorothee P
Brain 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
title Brain 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
title_full Brain 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
title_fullStr Brain 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
title_full_unstemmed Brain 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
title_short Brain 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
title_sort brain 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
topic Pharmacology and Therapeutics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10582853/
https://www.ncbi.nlm.nih.gov/pubmed/37844981
http://dx.doi.org/10.1136/bmjopen-2023-073378
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