NCT04433299

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2025

Completed
Last Updated

February 27, 2026

Status Verified

October 1, 2025

Enrollment Period

5.6 years

First QC Date

September 21, 2019

Last Update Submit

February 25, 2026

Conditions

Low Back Pain

Keywords

low back pain, phenotype

Outcome Measures

Primary Outcomes (2)

  • spatial pain extent

    spatial pain extent (body map)

    baseline

  • measures for central sensitization

    temporal summation and conditioned pain modulation

    baseline

Secondary Outcomes (2)

  • changes in spatial pain extent

    changes from baseline to 3 months

  • changes in measures for central sensitization

    changes from baseline to 3 months

Study Arms (2)

low back pain patients

no intervention

Other: no intervention, observational

controls

no intervention

Other: no intervention, observational

Interventions

no intervention, observationalOTHER

no intervention, observational

controlslow back pain patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients between 18 and 80 with low back pain

You may qualify if:

  • primary complaint: low back pain clinically not attributable to red flags

You may not qualify if:

  • any major medical or psychiatric condition that affects pain sensitivity
  • contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location

Related Publications (1)

  • Sirucek 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.

    PMID: 40372313DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample (6 ml)

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Petra Schweinhardt, MD, PhD

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2019

First Posted

June 16, 2020

Study Start

November 1, 2019

Primary Completion

June 3, 2025

Study Completion

June 3, 2025

Last Updated

February 27, 2026

Record last verified: 2025-10

Locations

CH(1)