The Impact of Positive, Neutral and Negative Expectation Speech on Manipulative Therapy Effects

Summary

The objective of this study will be to identify the short-term impact of positive, neutral, or negative speech on pain intensity (primary outcome). The secondary outcomes assessed will be the global perceived effect of improvement, patient's expectations regarding spinal manipulative therapy (SMT) intervention, and perception of empathy in the therapeutic encounter in patients with chronic low back pain (CLBP). This study will enroll 60 participants with CLBP aged between 18 and 60 years.

This is an exploratory randomized clinical trial. The three groups will receive a manual therapy session after watching the video proposed for their group.

First participants will be assessed for pain intensity, low back pain disability, psychosocial aspects, and expectations related to treatment. Secondly, a researcher not involved in the recruitment of patients will randomly allocate the participants into three different groups (G1- group submitted to positive expectation, G2- group submitted to neutral expectation, and G3- group submitted to negative expectation). After the allocation, the participants will watch a short video (no more than 3 minutes) delivering positive, negative, or neutral messages regarding SMT. And finally, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations.

Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated.

Outcomes will be assessed just immediately after one SMT session.

Conditions

• Chronic Low-back Pain

Interventions

OTHER

Positive expectation speech regarding spinal manipulative therapy

Patients will watch a short video with positive expectations regarding spinal manipulative therapy.

OTHER

Neutral expectation speech regarding spinal manipulative therapy

Patients will watch a short video with neutral expectations regarding spinal manipulative therapy.

OTHER

Negative expectation speech regarding spinal manipulative therapy

Patients will watch a short video with negative expectations regarding spinal manipulative therapy.

PROCEDURE

Spinal Manipulative Therapy

One session of Spinal Manipulative Therapy. The researcher will administer a posterior and inferior push on the opposite anterior superior iliac spine (ASIS) while passively rotating the subject on the side to be manipulated. The spinal manipulations will be repeated four times during a 5-minute period, with impulses oscillating between the right and left ASIS. In addition, we will administrate mobilizations (anterior-posterior central mobilization), applied for 1 minute in each lumbar vertebra (from L5 to L1), using grade I joint mobilization (patients positioned in the ventral decubitus position).

Sponsors & Collaborators

• Universidade Federal de Sao Carlos

  lead OTHER

Principal Investigators

• Thais C Chaves, PHD · Federal University of São Carlos - UFSCar

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-01

Primary Completion

2024-03-01

Completion

2024-12-15

Countries

• Brazil

Study Locations