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NCT05592405 Clinical Trial

Nociplastic Pain Symptoms and Sensory Profiles in Low Back Pain

Low Back Pain Clinical Trial

Official title:
Nociplastic Pain Measurement and Sensory Profiles in Patients With Acute and Chronic Low Back Pain: a Longitudinal Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05592405
Other study ID # QST_SPs
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date April 1, 2025

Study information
Verified date April 2024
Source Vrije Universiteit Brussel
Contact Pieter Gräper, MSc
Phone +3165693560
Email Pieter.Jan.Graper@vub.be
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Description:

Therefore, the investigators aims are: - The primary aim of the study is to assess associations between Sensory Profiles (Adolescent/Adult Sensory Profiles) and Nociplastic pain Symptoms, in the acute and chronic low back pain population. - The secondary aim is to assess the prognostic value of sensory profiles in the transition to central sensitisation and pain, in the acute and chronic low back pain population at twelve weeks.

Recruitment information / eligibility
Status Recruiting
Enrollment 103
Est. completion date April 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - patients with non-specific LBP - with or without radiating pain - aged 18-65 years - able to read and understand the Dutch language Exclusion Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Fysiomobilae Zwolle Overijssel

Sponsors (1)
Lead Sponsor Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Other Demograpics established prognostic factors for low back pain 12 weeks
Primary Central sensitiszation QST Quantitative sensory testing 12 weeks follow-up
Primary Central senzitization CSI Central sensitization inventory 12 weeks follow-up
Primary Central sensitization PSQ Pain sensitization questionnaire 12 weeks follow-up
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