Nociplastic Pain Symptoms and Sensory Profiles in Low Back Pain

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Back Pain; Central Sensitisation

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 Type: Observational
• Enrollment (Estimated): 103

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Zwolle, Overijssel, Netherlands
      • Fysiomobilae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demograpics	established prognostic factors for low back pain	12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: QST_SPs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Sharing is unlikely as the data set includes pseudo-anominizised highly confidential data, of which the participants do not gave their consent to use their provided data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No