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

NCT ID: NCT05996991

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-12-15

Brief 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.

Detailed Description

Background: The term "contextual effect" has been used to reinforce the view that the placebo effect should be understood as an effect related to the therapeutic context, and not restricted to the use of inert treatments. Thus, the placebo effect is inherent to any therapeutic context and also can be used to enhance the effects of treatment with active components. There is evidence of the effectiveness of manipulative therapy in the treatment of chronic low back pain (CLBP), however, for most physical therapy interventions, its effect is small. Thus, strategies to enhance the effects of this therapy, such as through the use of context factors, may contribute to better therapeutic outcomes. The literature describes that positively induced expectations can trigger a placebo effect. There are previous studies that investigated the effect of different speech on SMT in patients with chronic neck pain, but there is no study in CLBP. In addition, no previous study investigated further the perceptions of patients regarding the content and perceptions of the videos.

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)

Methods: it will be a randomized controlled trial with a blinded assessor. It will be investigated the effect of the use of a hidden conditioning procedure and the induction of positive expectations on pain intensity after the administration of a manipulative therapy approach.

This is an exploratory randomized clinical trial. The three groups will receive one session of SMT 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. It will help to understand if the content of the videos actually causes an impact on the expectations of the patients.

The main hypothesis of this study is that the group submitted to the positive expectation speech will have a higher hypoalgesic effect, greater perception of improvement, and higher expectations regarding SMT than the other groups immediately post-treatment.

Outcomes will be assessed just immediately after one SMT session.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

G1 - Positive Expectation Group + Spinal Manipulative Therapy

The participants of G1 will watch a short video (no more than 3 minutes) delivering a positive message regarding SMT. Secondly, 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.

Group Type: EXPERIMENTAL

Positive expectation speech regarding spinal manipulative therapy

Intervention Type: OTHER

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

Spinal Manipulative Therapy

Intervention Type: PROCEDURE

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).

G2 - Neutral Expectation Group + Spinal Manipulative Therapy

The participants of G1 will watch a short video (no more than 3 minutes) delivering a neutral message regarding SMT. Secondly, 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.

Group Type: ACTIVE_COMPARATOR

Neutral expectation speech regarding spinal manipulative therapy

Intervention Type: OTHER

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

Spinal Manipulative Therapy

Intervention Type: PROCEDURE

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).

G2 - Negative Expectation Group + Spinal Manipulative Therapy

The participants of G1 will watch a short video (no more than 3 minutes) delivering a negative message regarding SMT. Secondly, 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.

Group Type: ACTIVE_COMPARATOR

Negative expectation speech regarding spinal manipulative therapy

Intervention Type: OTHER

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

Spinal Manipulative Therapy

Intervention Type: PROCEDURE

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).

Interventions

Positive expectation speech regarding spinal manipulative therapy

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

Intervention Type: OTHER

Neutral expectation speech regarding spinal manipulative therapy

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

Intervention Type: OTHER

Negative expectation speech regarding spinal manipulative therapy

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

Intervention Type: OTHER

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).

Intervention Type: PROCEDURE

Other Intervention Names

Manual Therapy; Manual Therapy

Eligibility Criteria

Inclusion Criteria

1. Patients who report non-specific CLBP (in which the specific nociceptive source cannot be identified, confirmed by a medical assessment) for at least three months duration;

2. Age ranged from 18 years to 60 years

3. Baseline pain intensity score ≥3 on a Numeric Pain Rating Scale (NPRS) (because of the measurement error > 2 reported for the NPRS);

4. Patients able to speak and understand Portuguese well to fill out the questionnaires.

Exclusion Criteria

1. Previous poor experiences with SMT through the application of a brief screening questionnaire

2. Pregnancy

3. Specific low back pain disorders like radiculopathy or lumbar stenosis or chronic degenerative disorders, i.e., uncontrolled cardiovascular, metabolic, or systemic diseases, neurological or psychiatric diseases, and stroke sequelae

4. Undergoing other therapeutic interventions for chronic pain and low back pain (including surgeries) in the last 3 months

5. Presence of contraindications to SMT

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Thais Chaves

Adjunct Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thais C Chaves, PHD

Role: STUDY_CHAIR

Federal University of São Carlos - UFSCar

Locations

Federal University of São Carlos - Department of Physical Therapy

São Carlos, São Paulo, Brazil

Countries

Brazil

Central Contacts

Thais C Chaves, PhD

Role: CONTACT

thaischaves@ufscar.br

05516 996092206

Thamiris C Lima, PhD

Role: CONTACT

thamiriscl@estudante.ufscar.br

05516991533628

Facility Contacts

Thais C Chaves, PhD

Role: primary

thaischaves@ufscar.br

05516996092206

Thamiris C Lima, PhD

Role: backup

thamiriscl@estudante.ufscar.br

05516991533628

Other Identifiers

62827822.2.0000.5504

Identifier Type: -

Identifier Source: org_study_id