- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04433299
Back Pain - Linking Phenotype to Pain Mechanism and Outcome.
February 25, 2026 updated by: Balgrist University Hospital
To investigate whether different clinical, psychophysical and neurophysiological phenotypes can be identified among low back pain patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Canton of Zurich
-
Zurich, Canton of Zurich, Switzerland, 8008
- Balgrist University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients between 18 and 80 with low back pain
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
low back pain patients
no intervention
|
no intervention, observational
|
|
controls
no intervention
|
no intervention, observational
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
spatial pain extent
Time Frame: baseline
|
spatial pain extent (body map)
|
baseline
|
|
measures for central sensitization
Time Frame: baseline
|
temporal summation and conditioned pain modulation
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in spatial pain extent
Time Frame: changes from baseline to 3 months
|
changes in spatial pain extent (bodymap)
|
changes from baseline to 3 months
|
|
changes in measures for central sensitization
Time Frame: changes from baseline to 3 months
|
changes in temporal summation and conditioned pain modulation
|
changes from baseline to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Petra Schweinhardt, MD, PhD, Balgrist University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2019
Primary Completion (Actual)
June 3, 2025
Study Completion (Actual)
June 3, 2025
Study Registration Dates
First Submitted
September 21, 2019
First Submitted That Met QC Criteria
June 12, 2020
First Posted (Actual)
June 16, 2020
Study Record Updates
Last Update Posted (Actual)
February 27, 2026
Last Update Submitted That Met QC Criteria
February 25, 2026
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-00136
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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