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NCT04433299 Clinical Trial

Back Pain - Linking Phenotype to Pain Mechanism and Outcome.

Low Back Pain Clinical Trial

Official title:
Back Pain - Linking Phenotype to Pain Mechanism and Outcome.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04433299
Other study ID # 2019-00136
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 31, 2024

Study information
Verified date August 2023
Source Balgrist University Hospital
Contact Lucas Tauschek, BSc
Phone +41 44 386 57 11
Email lucas.tauschek@balgrist.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate whether different clinical, psychophysical and neurophysiological phenotypes can be identified among low back pain patients

Description:

Low back pain patients will fill in a detailed questionnaire (incl. pain drawing) about their pain. Some of them will undergo a standardized quantitative sensory testing protocol and an fMRI procedure.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: -primary complaint: low back pain clinically not attributable to red flags Exclusion Criteria: - any major medical or psychiatric condition that affects pain sensitivity - contraindications to MRI

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention, observational
no intervention, observational

Locations
Country Name City State
Switzerland Balgrist University Hospital Zürich Zurich

Sponsors (2)
Lead Sponsor Collaborator
Balgrist University Hospital University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary spatial pain extent spatial pain extent (body map) baseline
Primary measures for central sensitization temporal summation and conditioned pain modulation baseline
Secondary changes in spatial pain extent changes in spatial pain extent (bodymap) changes from baseline to 3 months
Secondary changes in measures for central sensitization changes in temporal summation and conditioned pain modulation changes from baseline to 3 months
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