NCT04433299RecruitingNot Applicable
Back Pain - Linking Phenotype to Pain Mechanism and Outcome.
Balgrist University Hospital1 site in 1 country150 target enrollmentStarted: November 1, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- measures for central sensitization
Study Overview
Brief Summary
To investigate whether different clinical, psychophysical and neurophysiological phenotypes can be identified among low back pain patients
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
measures for central sensitization
Time Frame: baseline
temporal summation and conditioned pain modulation
spatial pain extent
Time Frame: baseline
spatial pain extent (body map)
Secondary Outcomes
- changes in measures for central sensitization(changes from baseline to 3 months)
- changes in spatial pain extent(changes from baseline to 3 months)
Investigators
Study Sites (1)
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