The Impact of Positive, Neutral and Negative Expectation Speech on Manipulative Therapy Effects
Understanding the Impact of Positive, Neutral and Negative Expectation Speech Regarding Manual Therapy Intervention in Patients With Chronic Low Back Pain: a Pilot Study
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2023
CompletedFirst Posted
Study publicly available on registry
August 18, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2024
CompletedAugust 18, 2023
August 1, 2023
5 months
August 4, 2023
August 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain intensity
The Numeric Pain Rating Scale (NPRS) will be used to assess pain intensity in this trial and consists in a sequence of numbers from zero to ten, in which zero represents "no pain" and 10 represents "worst pain imaginable"
one-hour after the baseline assessment
Secondary Outcomes (4)
Global Perceived Effect (GPE) of Improvement
one-hour after the baseline assessment
Low-back Pain (LBP) Expectation Scale
one-hour after the baseline assessment
Treatment Expectations in Chronic Pain Scale (TEC)
one-hour after the baseline assessment
Empathy - Care Scale
one-hour after the baseline assessment
Study Arms (3)
G1 - Positive Expectation Group + Spinal Manipulative Therapy
EXPERIMENTALThe 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.
G2 - Neutral Expectation Group + Spinal Manipulative Therapy
ACTIVE COMPARATORThe 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.
G2 - Negative Expectation Group + Spinal Manipulative Therapy
ACTIVE COMPARATORThe 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.
Interventions
Patients will watch a short video with positive expectations regarding spinal manipulative therapy.
Patients will watch a short video with neutral expectations regarding spinal manipulative therapy.
Patients will watch a short video with negative expectations regarding 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).
Eligibility Criteria
You may qualify if:
- 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;
- Age ranged from 18 years to 60 years
- Baseline pain intensity score ≥3 on a Numeric Pain Rating Scale (NPRS) (because of the measurement error \> 2 reported for the NPRS);
- Patients able to speak and understand Portuguese well to fill out the questionnaires.
You may not qualify if:
- Previous poor experiences with SMT through the application of a brief screening questionnaire
- Pregnancy
- 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
- Undergoing other therapeutic interventions for chronic pain and low back pain (including surgeries) in the last 3 months
- Presence of contraindications to SMT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of São Carlos - Department of Physical Therapy
São Carlos, São Paulo, 13.565-905, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Thais C Chaves, PHD
Federal University of São Carlos - UFSCar
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct Professor
Study Record Dates
First Submitted
August 4, 2023
First Posted
August 18, 2023
Study Start
October 1, 2023
Primary Completion
March 1, 2024
Study Completion
December 15, 2024
Last Updated
August 18, 2023
Record last verified: 2023-08