The Impact of Positive, Neutral and Negative Expectation Speech on Manipulative Therapy Effects
Unknown statusNot applicableNCT05996991
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Understanding the Impact of Positive, Neutral and Negative Expectation Speech Regarding Manual Therapy Intervention in Patients With Chronic Low Back Pain: a Pilot Study
- Conditions
- Interventions
- Other: Positive expectation speech regarding spinal manipulative therapy
- Other: Neutral expectation speech regarding spinal manipulative therapy
- Other: Negative expectation speech regarding spinal manipulative therapy
- Procedure: Spinal Manipulative Therapy
- Sponsor
- Universidade Federal de Sao Carlos
- Start date
- 2023-10-01
- Primary completion
- 2024-03-01
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- Brazil
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05996991