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Nociplastic Pain Symptoms and Sensory Profiles in Low Back Pain

Sponsor
Vrije Universiteit Brussel (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05592405
Collaborator
(none)
103
Enrollment
1
Location
18
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    103 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Nociplastic Pain Measurement and Sensory Profiles in Patients With Acute and Chronic Low Back Pain: a Longitudinal Observational Cohort Study
    Anticipated Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Apr 1, 2024
    Anticipated Study Completion Date :
    Oct 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Central sensitiszation QST [12 weeks follow-up]

      Quantitative sensory testing

    2. Central senzitization CSI [12 weeks follow-up]

      Central sensitization inventory

    3. Central sensitization PSQ [12 weeks follow-up]

      Pain sensitization questionnaire

    Other Outcome Measures

    1. Demograpics [12 weeks]

      established prognostic factors for low back pain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fysiomobilae Zwolle Overijssel Netherlands

    Sponsors and Collaborators

    • Vrije Universiteit Brussel

    Investigators

    • Study Director: Aldo Scafoglieri, PhD, Vrije Universiteit Brussel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pieter Graper, Principal investigator, Vrije Universiteit Brussel
    ClinicalTrials.gov Identifier:
    NCT05592405
    Other Study ID Numbers:
    • QST_SPs
    First Posted:
    Oct 24, 2022
    Last Update Posted:
    Oct 27, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Back Pain
    Low Back Pain

    Study Results

    No Results Posted as of Oct 27, 2022