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  • Mechanisms of chiropractic spinal manipulative therapy for patients with chronic primary low back pain: protocol for a mechanistic randomised placebo-controlled trial

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Complementary medicine
Protocol
Mechanisms of chiropractic spinal manipulative therapy for patients with chronic primary low back pain: protocol for a mechanistic randomised placebo-controlled trial
  1. Carlos Gevers-Montoro1,2,
  2. Arantxa Ortega-De Mues1,
  3. Mathieu Piché2,3
  1. 1Chiropractic, Real Centro Universitario Escorial Maria Cristina, San Lorenzo de El Escorial, Spain
  2. 2Department of Anatomy, Université du Québec à Trois-Rivières, Trois-Rivieres, Quebec, Canada
  3. 3CogNAC (Cognition, Neurosciences, Affect et Comportement) Research Group, Université du Québec à Trois-Rivières, Trois-Rivieres, Quebec, Canada
  1. Correspondence to Dr Mathieu Piché; mathieu.piche{at}uqtr.ca

Abstract

Introduction Chronic low back pain (CLBP) is a highly prevalent and disabling condition. Identifying subgroups of patients afflicted with CLBP is a current research priority, for which a classification system based on pain mechanisms was proposed. Spinal manipulative therapy (SMT) is recommended for the management of CLBP. Yet, little data are available regarding its mechanisms of action, making it difficult to match this intervention to the patients who may benefit the most. It was suggested that SMT may influence mechanisms associated with central sensitisation. Therefore, classifying patients with CLBP according to central sensitisation mechanisms may help predict their response to SMT.

Methods and analysis This protocol describes a randomised placebo-controlled trial aiming to examine which variables linked to central sensitisation may help predict the clinical response to SMT in a cohort of patients with CLBP. One hundred patients with chronic primary low back pain will be randomised to receive 12 sessions of SMT or placebo SMT over a 4-week period. Pain intensity and disability will be assessed as primary outcomes after completing the 4-week treatment (primary endpoint), and at 4-week and 12-week follow-ups. Baseline values of two pain questionnaires, lumbar pressure pain thresholds, concentrations of an inflammatory cytokine and expectations of pain relief will be entered as predictors of the response to SMT in a multiple regression model. Changes in these variables after treatment will be used in a second multiple regression model. The reference values of these predictors will be measured from 50 age and sex-matched healthy controls to allow interpretation of values in patients. Mixed analyses of variance will also be conducted to compare the primary outcomes and the predictors between groups (SMT vs placebo) over time (baseline vs post-treatment).

Ethics and dissemination Ethical approval was granted by the Fundación Jiménez Díaz Clinical Research Ethics Committee.

Trial registration number NCT05162924.

  • Clinical trials
  • Back pain
  • COMPLEMENTARY MEDICINE
  • IMMUNOLOGY
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2022-065999

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    Footnotes

    • Twitter @CarlosGeversDC

    • Contributors All authors contributed to the design of this protocol. CG-M and MP conceptualised and designed the protocol, except for every aspect related to laboratory analyses, which were conceptualised by AO-DM. The protocol was drafted by CG-M, and revised by MP and AO-DM. The statistical analysis was designed by MP. CG-M was responsible for ethical committee approval.

    • Funding This work was supported by the Chaire de Recherche Internationale en Santé Neuromusculosquelettique. CG-M’s work was supported by the Fonds de Recherche du Québec en Nature et Technologies (FRQNT), the Asociación Española de Quiropráctica (AEQ) and the European Centre for Chiropractic Research Excellence (ECCRE). AO-DM’s work was supported by ECCRE. MP’s work was supported by the Fondation de Recherche en Chiropratique du Québec and the Fonds de Recherche du Québec en Santé (FRQS).

    • 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.