UnknownNot Applicable

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

Brazil60 participantsStarted 2023-10-01

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain intensity

Timeframe: one-hour after the baseline assessment

Trial details

NCT IDNCT05996991

SponsorUniversidade Federal de Sao Carlos

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-01

Contact for this trial

Thais C Chaves, PhD

05516 996092206 thaischaves@ufscar.br

View on ClinicalTrials.gov More Chronic Low-back Pain trials