Low Back PainNCT04433299
Back Pain - Linking Phenotype to Pain Mechanism and Outcome.
An observational study of Low Back Pain, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
To investigate whether different clinical, psychophysical and neurophysiological phenotypes can be identified among low back pain patients Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2019to 3 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients between 18 and 80 with low back pain
Who may be able to join
- -primary complaint: low back pain clinically not attributable to red flags
Who cannot join
- any major medical or psychiatric condition that affects pain sensitivity
- contraindications to MRI
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
About this study
To investigate whether different clinical, psychophysical and neurophysiological phenotypes can be identified among low back pain patients
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- no intervention, observational
- Keywords
- low back pain, phenotype
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, observationalOther
no intervention, observational
| Study group | Role | What they receive |
|---|---|---|
| low back pain patients | no intervention Receives: Other: no intervention, observational | |
| controls | no intervention Receives: Other: no intervention, observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
spatial pain extent
spatial pain extent (body map)
Measured: baseline
measures for central sensitization
temporal summation and conditioned pain modulation
Measured: baseline
Secondary outcomes (2)
changes in spatial pain extent
changes in spatial pain extent (bodymap)
Measured: changes from baseline to 3 months
changes in measures for central sensitization
changes in temporal summation and conditioned pain modulation
Measured: changes from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Nov 2019
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Petra Schweinhardt, MD, PhD, Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433299
- Sponsor's protocol ID
- 2019-00136
- Other IDs
- 2019
- Status last verified
- Oct 2025
- First submitted
- 21 Sep 2019
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chozas Barrientos B, De Schoenmacker I, Scheuren PS, Sirucek L, Costa Marques D, Lutolf R, Gorrell L, Langenfeld A, Baechler M, Wirth B, Rosner J, Hubli M, Schweinhardt P. Dysregulated Pain-Autonomic Responses in Patients With Nonspecific Chronic Low Back Pain. Pain Res Manag. 2026;2026(1):e6637632. doi: 10.1155/prm/6637632.
PubMed 42538744Sirucek L, De Schoenmacker I, Gorrell LM, Lutolf R, Langenfeld A, Baechler M, Wirth B, Hubli M, Zolch N, Schweinhardt P. The periaqueductal gray in chronic low back pain: dysregulated neurotransmitters and function. Pain. 2025 May 15;166(7):1690-1705. doi: 10.1097/j.pain.0000000000003617.
PubMed 40372313Gozzi N, Preatoni G, Ciotti F, Hubli M, Schweinhardt P, Curt A, Raspopovic S. Unraveling the physiological and psychosocial signatures of pain by machine learning. Med. 2024 Dec 13;5(12):1495-1509.e5. doi: 10.1016/j.medj.2024.07.016. Epub 2024 Aug 7.
PubMed 39116869
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back Pain - Linking Phenotype to Pain Mechanism and Outcome.
- ClinicalTrials.gov ID
- NCT04433299
- Acronym / sponsor ID
- 2019-00136
- Conditions
- Low Back Pain
- Keywords
- low back pain, phenotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low back pain patients | – | Other: no intervention, observationalno intervention |
| controls | – | Other: no intervention, observationalno intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between 18 and 80 with low back pain
Key inclusion criteria (1 listed)
- -primary complaint: low back pain clinically not attributable to red flags
Key exclusion criteria (2 listed)
- any major medical or psychiatric condition that affects pain sensitivity
- contraindications to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention, observationalno intervention, observational | Other | controls, low back pain patients |
Primary outcome
spatial pain extent
Time frame: baseline
spatial pain extent (body map)
measures for central sensitization
Time frame: baseline
temporal summation and conditioned pain modulation
2 secondary outcomes
changes in spatial pain extent
Time frame: changes from baseline to 3 months
changes in measures for central sensitization
Time frame: changes from baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Derived from this study: PubMed 42538744Chozas Barrientos B, De Schoenmacker I, Scheuren PS, Sirucek L, Costa Marques D, Lutolf R, Gorrell L, Langenfeld A, Baechler M, Wirth B, Rosner J, Hubli M, Schweinhardt P. Dysregulated Pain-Autonomic Responses in Patients With Nonspecific Chronic Low Back Pain. Pain Res Manag. 2026;2026(1):e6637632. doi: 10.1155/prm/6637632.
- Derived from this study: PubMed 40372313Sirucek L, De Schoenmacker I, Gorrell LM, Lutolf R, Langenfeld A, Baechler M, Wirth B, Hubli M, Zolch N, Schweinhardt P. The periaqueductal gray in chronic low back pain: dysregulated neurotransmitters and function. Pain. 2025 May 15;166(7):1690-1705. doi: 10.1097/j.pain.0000000000003617.
- Derived from this study: PubMed 39116869Gozzi N, Preatoni G, Ciotti F, Hubli M, Schweinhardt P, Curt A, Raspopovic S. Unraveling the physiological and psychosocial signatures of pain by machine learning. Med. 2024 Dec 13;5(12):1495-1509.e5. doi: 10.1016/j.medj.2024.07.016. Epub 2024 Aug 7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Schweinhardt, MD, PhD principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spatial pain extent (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04433299, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.