Mechanisms of chiropractic spinal manipulative therapy for patients with chronic primary low back pain: protocol for a mechanistic randomised placebo-controlled trial.
| Title: | 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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| Authors: | Gevers-Montoro C; Chiropractic, Real Centro Universitario Escorial Maria Cristina, San Lorenzo de El Escorial, Spain.; Department of Anatomy, Université du Québec à Trois-Rivières, Trois-Rivieres, Quebec, Canada.; Ortega-De Mues A; Chiropractic, Real Centro Universitario Escorial Maria Cristina, San Lorenzo de El Escorial, Spain.; Piché M; Department of Anatomy, Université du Québec à Trois-Rivières, Trois-Rivieres, Quebec, Canada mathieu.piche@uqtr.ca.; CogNAC (Cognition, Neurosciences, Affect et Comportement) Research Group, Université du Québec à Trois-Rivières, Trois-Rivieres, Quebec, Canada. |
| Source: | BMJ open [BMJ Open] 2023 Feb 10; Vol. 13 (2), pp. e065999. Date of Electronic Publication: 2023 Feb 10. |
| Publication Type: | Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't |
| Language: | English |
| Journal Info: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| MeSH Terms: | Low Back Pain*/therapy ; Low Back Pain*/etiology ; Manipulation, Spinal*/adverse effects ; Chronic Pain*/therapy ; Chronic Pain*/etiology ; Chiropractic*; Humans ; Spine ; Pain Threshold ; Treatment Outcome ; Randomized Controlled Trials as Topic |
| 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.; (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
| Competing Interests: | Competing interests: None declared. |
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| Contributed Indexing: | Keywords: Back pain; COMPLEMENTARY MEDICINE; Clinical trials; IMMUNOLOGY |
| Molecular Sequence: | ClinicalTrials.gov NCT05162924 |
| Entry Date(s): | Date Created: 20230210 Date Completed: 20230214 Latest Revision: 20240912 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC9923302 |
| DOI: | 10.1136/bmjopen-2022-065999 |
| PMID: | 36764718 |
| Database: | MEDLINE |
Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't