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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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2023
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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. |
format | Online Article Text |
id | pubmed-10106070 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
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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