Status:
UNKNOWN
Investigating the Hypoalgesic Effects of Manipulative Therapy Using Pain Conditioning and Expectations in Low Back Pain
Lead Sponsor:
Universidade Federal de Sao Carlos
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The objective of this study will be to identify whether a conditioning procedure by the surreptitious downgrade of a noxious stimulus intensity associated with induced positive expectations about trea...
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- The inclusion criteria for patients were as follows:
- 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);
- Score greater than 14% on the Oswestry Disability Index (ODI) (to surpass the smallest detectable change of the ODI total score
- Patients able to speak and understand Portuguese well to fill out the questionnaires.
- Patients will be excluded if they met any of the following criteria:
- 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
- Patients who reach the upper limit of 50ºC, which is the maximum temperature provided by the Q-sense equipment described in the Medoc, Israel website
Exclusion
Key Trial Info
Start Date :
February 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 10 2024
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT05202704
Start Date
February 20 2022
End Date
March 10 2024
Last Update
March 23 2023
Active Locations (1)
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1
Unidade Saúde Escola - USE
São Carlos, São Paulo, Brazil, 13.565-905