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NCT Number: NCT05592405

Nociplastic Pain Symptoms and Sensory Profiles in Low Back Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Central Sensitisation Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fysiomobilae

Zwolle, Overijssel, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Central sensitiszation QST

    Time frame: 12 weeks follow-up

    Quantitative sensory testing

  2. Central senzitization CSI

    Time frame: 12 weeks follow-up

    Central sensitization inventory

  3. Central sensitization PSQ

    Time frame: 12 weeks follow-up

    Pain sensitization questionnaire

Other outcomes

  1. Demograpics

    Time frame: 12 weeks

    established prognostic factors for low back pain

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 24, 2022
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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