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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

Lankappa, Sudheer
; 
Drabek, Marianne
; 
Hodkinson, Duncan
; 
Horvath, Suzanne
; 
Millar, Bonnie
; 
Pszczolkowski Parraguez, Stefan
; 
Tench, Christopher R
; 
Tanasescu, Radu
; 
Morriss, Richard
; 
Walsh, David
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Abstract
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.
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Date
2023-10-16
Type
Article
Subject
Osteoarthritis
 Brain
 Transcranial Magnetic Stimulation
 Chronic Pain
 Knee, Osteoarthritis
Collections
NottsHC Musculoskeletal Disorders
NUH Neurology
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Citation
Drabek M, Hodkinson D, Horvath S, Millar B, Pszczolkowski Parraguez S, Tench CR, Tanasescu R, Lankappa S, Morriss R, Walsh D, Auer DP. 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. BMJ Open. 2023 Oct 16;13(10):e073378. doi: 10.1136/bmjopen-2023-073378.
Journal / Source Title
BMJ Open
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URI
https://mider.dspace7.openrepository.com/handle/20.500.12904/17816
PMID
37844981
Publisher
BMJ Group
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Publisher’s statement
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. Open access 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/.
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