NCT05592405

Brief Summary

Assessing associations between Sensory profiles and nociplastic pain symptoms, and assessing the prognostic value of sensory profiles in the development of nociplastic pain symptoms in a low back pain population.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

October 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

October 19, 2022

Last Update Submit

March 25, 2025

Conditions

Central SensitisationLow Back Pain

Outcome Measures

Primary Outcomes (3)

  • Central sensitiszation QST

    Quantitative sensory testing

    12 weeks follow-up

  • Central senzitization CSI

    Central sensitization inventory

    12 weeks follow-up

  • Central sensitization PSQ

    Pain sensitization questionnaire

    12 weeks follow-up

Other Outcomes (1)

  • Demograpics

    12 weeks

Eligibility Criteria

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

Evaluation of eligibility will take place during assessment when the participant reports in primary care physiotherapy practice for the treatment of LBP. Patients will be included consecutively and measurements will be obtained by the investigator.

You may qualify if:

  • patients with non-specific LBP
  • with or without radiating pain
  • aged 18-65 years
  • able to read and understand the Dutch language

You may not qualify if:

  • previous lumbar spinal surgery
  • radiculopathy or any specific cause of low back pain such as lumbar spinal stenosis, current malignancy, spondyloarthropathy, osteoporosis, spondylolisthesis, major trauma, infection, or systemic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fysiomobilae

Zwolle, Overijssel, Netherlands

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aldo Scafoglieri, PhD

    Vrije Universiteit Brussel

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 19, 2022

First Posted

October 24, 2022

Study Start

June 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Locations

NL(1)