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Investigating the hypoalgesic effects of spinal manipulative therapy using hidden pain conditioning and positive expectation in patients with chronic low back pain: protocol for a randomised controlled trial

INTRODUCTION: Placebo effects are responses capable of modulating pain and influencing treatment response. Two mechanisms are commonly related to placebo effects: expectations and conditioning. However, the research in this field is focused on laboratory studies with healthy participants. This study...

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Autores principales: Nogueira Carrer, Helen Cristina, de Lima, Thamiris Costa, George, Steven Z, dos Reis, Felipe José Jandre, Dias, Deise Lilian Costa, Campanha, Bianca Emanuelli Saes, Chaves, Thaís Cristina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10106070/
https://www.ncbi.nlm.nih.gov/pubmed/37045570
http://dx.doi.org/10.1136/bmjopen-2022-066199
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author Nogueira Carrer, Helen Cristina
de Lima, Thamiris Costa
George, Steven Z
dos Reis, Felipe José Jandre
Dias, Deise Lilian Costa
Campanha, Bianca Emanuelli Saes
Chaves, Thaís Cristina
author_facet Nogueira Carrer, Helen Cristina
de Lima, Thamiris Costa
George, Steven Z
dos Reis, Felipe José Jandre
Dias, Deise Lilian Costa
Campanha, Bianca Emanuelli Saes
Chaves, Thaís Cristina
author_sort Nogueira Carrer, Helen Cristina
collection PubMed
description INTRODUCTION: Placebo effects are responses capable of modulating pain and influencing treatment response. Two mechanisms are commonly related to placebo effects: expectations and conditioning. However, the research in this field is focused on laboratory studies with healthy participants. This study aims to identify whether a conditioning procedure with positive induced expectations about spinal manipulative therapy (SMT) will result in greater hypoalgesic effects in adults with chronic low back pain (CLBP) in a clinical trial design. METHODS AND ANALYSIS: This trial will enrol 264 patients with non-specific CLBP, aged 18–60 years. Patients will undergo a calibration test to determine the thermal pain threshold for the hidden pain conditioning procedure. Afterward, they will be randomised to one of the three groups: hidden pain conditioning with positive induced expectations—group one (G1); positive expectations—group two (G2) and neutral expectations—group three (G3). Patients will receive instructions to manipulate the expectations. The pretreatment heat pain test will be performed before the SMT and after the intervention patients will undergo again the heat pain intensity test. However, only patients in G1 will receive hidden pain conditioning to reinforce the association between SMT and pain intensity reduction. All patients will undergo five sessions of SMT. The outcomes will be assessed immediately after the last session and at the 6 weeks and 3-month follow-ups. All statistical analyses will be conducted following intention-to-treat principles, and the treatment effects will be determined with linear mixed models. ETHICS AND DISSEMINATION: The Federal University of São Carlos approved this research (Process n° 52359521.1.0000.5504). All participants will give written informed consent. Dissemination of the results will include publications in peer-reviewed journals and presentations at conferences. If positive expectations and classical conditioning improve outcomes, it may support the administration of such intervention. TRIAL REGISTRATION NUMBER: NCT05202704.
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spelling pubmed-101060702023-04-17 Investigating the hypoalgesic effects of spinal manipulative therapy using hidden pain conditioning and positive expectation in patients with chronic low back pain: protocol for a randomised controlled trial Nogueira Carrer, Helen Cristina de Lima, Thamiris Costa George, Steven Z dos Reis, Felipe José Jandre Dias, Deise Lilian Costa Campanha, Bianca Emanuelli Saes Chaves, Thaís Cristina BMJ Open Rehabilitation Medicine INTRODUCTION: Placebo effects are responses capable of modulating pain and influencing treatment response. Two mechanisms are commonly related to placebo effects: expectations and conditioning. However, the research in this field is focused on laboratory studies with healthy participants. This study aims to identify whether a conditioning procedure with positive induced expectations about spinal manipulative therapy (SMT) will result in greater hypoalgesic effects in adults with chronic low back pain (CLBP) in a clinical trial design. METHODS AND ANALYSIS: This trial will enrol 264 patients with non-specific CLBP, aged 18–60 years. Patients will undergo a calibration test to determine the thermal pain threshold for the hidden pain conditioning procedure. Afterward, they will be randomised to one of the three groups: hidden pain conditioning with positive induced expectations—group one (G1); positive expectations—group two (G2) and neutral expectations—group three (G3). Patients will receive instructions to manipulate the expectations. The pretreatment heat pain test will be performed before the SMT and after the intervention patients will undergo again the heat pain intensity test. However, only patients in G1 will receive hidden pain conditioning to reinforce the association between SMT and pain intensity reduction. All patients will undergo five sessions of SMT. The outcomes will be assessed immediately after the last session and at the 6 weeks and 3-month follow-ups. All statistical analyses will be conducted following intention-to-treat principles, and the treatment effects will be determined with linear mixed models. ETHICS AND DISSEMINATION: The Federal University of São Carlos approved this research (Process n° 52359521.1.0000.5504). All participants will give written informed consent. Dissemination of the results will include publications in peer-reviewed journals and presentations at conferences. If positive expectations and classical conditioning improve outcomes, it may support the administration of such intervention. TRIAL REGISTRATION NUMBER: NCT05202704. BMJ Publishing Group 2023-04-11 /pmc/articles/PMC10106070/ /pubmed/37045570 http://dx.doi.org/10.1136/bmjopen-2022-066199 Text en © 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. https://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://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Rehabilitation Medicine
Nogueira Carrer, Helen Cristina
de Lima, Thamiris Costa
George, Steven Z
dos Reis, Felipe José Jandre
Dias, Deise Lilian Costa
Campanha, Bianca Emanuelli Saes
Chaves, Thaís Cristina
Investigating the hypoalgesic effects of spinal manipulative therapy using hidden pain conditioning and positive expectation in patients with chronic low back pain: protocol for a randomised controlled trial
title Investigating the hypoalgesic effects of spinal manipulative therapy using hidden pain conditioning and positive expectation in patients with chronic low back pain: protocol for a randomised controlled trial
title_full Investigating the hypoalgesic effects of spinal manipulative therapy using hidden pain conditioning and positive expectation in patients with chronic low back pain: protocol for a randomised controlled trial
title_fullStr Investigating the hypoalgesic effects of spinal manipulative therapy using hidden pain conditioning and positive expectation in patients with chronic low back pain: protocol for a randomised controlled trial
title_full_unstemmed Investigating the hypoalgesic effects of spinal manipulative therapy using hidden pain conditioning and positive expectation in patients with chronic low back pain: protocol for a randomised controlled trial
title_short Investigating the hypoalgesic effects of spinal manipulative therapy using hidden pain conditioning and positive expectation in patients with chronic low back pain: protocol for a randomised controlled trial
title_sort investigating the hypoalgesic effects of spinal manipulative therapy using hidden pain conditioning and positive expectation in patients with chronic low back pain: protocol for a randomised controlled trial
topic Rehabilitation Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10106070/
https://www.ncbi.nlm.nih.gov/pubmed/37045570
http://dx.doi.org/10.1136/bmjopen-2022-066199
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