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.

Abstract

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. 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. 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. NCT05202704.