Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients
NCT ID: NCT04879394
Last Updated: 2022-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2022-05-16
2023-12-31
Brief Summary
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Detailed Description
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This is a Prospective Randomized Controlled Trial, with an experimental (hypnosis) and one control group (standard care), and 5 assessment points: baseline, post intervention, 1, 3 and 6 months follow-up. Participants will be 160 CLBP patients and 50 pain free adults, assessed on sociodemographic, clinical, pain, disability, psychophysical (Quantitative Sensory Testing) and psychological variables.
This work will contribute to a better knowledge of the mechanisms underlying CLBP and of the patient characteristics that can predict treatment outcomes after hypnosis. The findings have the potential to improve patient-targeted treatment approaches.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Hypnosis
4 weekly hypnosis sessions, aiming at pain control and distress management. The 90 min. sessions will be conducted in group format by a doctorate-level psychologist trained in hypnosis. Contents will be detailed on hypnosis protocols to ensure standardization.
Hypnosis
4 weekly hypnosis sessions, aiming at pain control and distress management. The 90 min. sessions will be conducted in group format by a doctorate-level psychologist trained in hypnosis. Contents will be detailed on hypnosis protocols to ensure standardization.
Control
Receives standard care as usual. Assessments will be made in the same time points as experimental group, but without undergoing intervention.
No interventions assigned to this group
Interventions
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Hypnosis
4 weekly hypnosis sessions, aiming at pain control and distress management. The 90 min. sessions will be conducted in group format by a doctorate-level psychologist trained in hypnosis. Contents will be detailed on hypnosis protocols to ensure standardization.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* back surgery in the previous 6 months or planned in the following 6 months
* debilitating organic, psychiatric or neurological conditions (e.g. cancer, schizophrenia, dementia)
* disability compensation or litigation related to CLBP
* unavailability to commit to the hypnosis sessions.
18 Years
70 Years
ALL
Yes
Sponsors
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Hospital de Braga
OTHER
Clinical Academic Center (2CA-Braga)
OTHER
University of Minho
OTHER
Responsible Party
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Patrícia Ribeiro Pinto
Researcher
Principal Investigators
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Patrícia R Pinto, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minho
Locations
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Hospital de Braga
Braga, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Joana Reis
Role: primary
Other Identifiers
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2CA2019
Identifier Type: -
Identifier Source: org_study_id
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