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  • Is there a difference in the analgesic response to intra-articular bupivacaine injection in people with knee osteoarthritis pain with or without central sensitisation? Protocol of a feasibility randomised controlled trial

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Patient-centred medicine
Protocol
Is there a difference in the analgesic response to intra-articular bupivacaine injection in people with knee osteoarthritis pain with or without central sensitisation? Protocol of a feasibility randomised controlled trial
  1. Yasmine Zedan1,2,3,
  2. Roger Knaggs4,
  3. Dale Cooper5,
  4. Thomas Kurien2,6,
  5. David Andrew Walsh2,7,
  6. Dorothee P Auer1,2,3,
  7. Brigitte E Scammell2,6
  1. 1Radiological Sciences, Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK
  2. 2Pain Centre Versus Arthritis, School of Medicine, University of Nottingham, Nottingham, UK
  3. 3Sir Peter Mansfield Imaging Centre, School of Medicine, University of Nottingham, Nottingham, UK
  4. 4Clinical Pharmacy Practice, School of Pharmacy, University of Nottingham, Nottingham, UK
  5. 5School of Allied Health Professions, Keele University, Keele, UK
  6. 6Academic Orthopaedics, Trauma and Sports Medicine, School of Medicine, University of Nottingham, Nottingham, UK
  7. 7Academic Rheumatology, School of Medicine, University of Nottingham, Nottingham, UK
  1. Correspondence to Professor Brigitte E Scammell; b.scammell{at}nottingham.ac.uk

Abstract

Introduction Pain is the main symptom of osteoarthritis (OA) with approximately 50% of patients reporting moderate-to-severe pain. Total knee replacement (TKR) is the ultimate treatment option to alleviate pain in knee OA. Nevertheless, TKR does not provide complete relief for all as approximately 20% of patients experience chronic postoperative pain. Painful peripheral stimuli may alter the central nociceptive pathways leading to central sensitisation that can influence treatment response in patients with OA. Currently, there is no objective protocol for detecting whether a patient will respond to a given treatment. Therefore, there is a need for a better mechanistic understanding of individual factors affecting pain relief, consequently informing personalised treatment guidelines. The purpose of this research is to examine the feasibility of conducting a full-scale mechanistic clinical trial in painful knee OA investigating the analgesic response to intra-articular bupivacaine between those with or without evidence of central sensitisation.

Methods and analysis The Understanding Pain mechanisms in KNEE osteoarthritis (UP-KNEE) study is a feasibility, double-blinded, placebo-controlled randomised parallel study in participants with radiographically defined knee OA and with self-reported chronic knee pain. The study involves the following assessments: (1) a suite of psychometric questionnaires; (2) quantitative sensory testing; (3) magnetic resonance imaging (MRI) scan of the knee and brain; (4) a 6-minute walk test; and (5) an intra-articular injection of bupivacaine or placebo (sodium chloride 0.9%) into the index knee. Assessments will be repeated post intra-articular injection apart from the MRI scan of the knee. Our aim is to provide proof of concept and descriptive statistics to power a future mechanistic trial.

Ethics and dissemination Ethical approval was obtained from the Health Research Authority (HRA) (REC: 20/EM/0287). Results will be disseminated via peer-reviewed journals and scientific conferences. The results will also be shared with lay audiences through relevant channels, such as Pain Centre Versus Arthritis website and patient advocacy groups.

Trial registration number NCT05561010.

  • knee
  • musculoskeletal disorders
  • protocols & guidelines
  • magnetic resonance imaging
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/.

https://doi.org/10.1136/bmjopen-2023-072138

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    Footnotes

    • Contributors BES conceived the study and designed the protocol with YZ, RK, DC, TK, DAW and DPA. YZ communicated with the Regulatory Authorities, initiated the study and wrote the first draft of the manuscript. All authors reviewed and approved this manuscript for submission.

    • Funding This project is supported by Versus Arthritis (Grant reference number: 20777).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.