Nociplastic Pain Symptoms and Sensory Profiles in Low Back Pain

Active, not recruiting

• Conditions: Central Sensitisation; Low Back Pain

• Registration Number: NCT05592405
• Lead Sponsor: Vrije Universiteit Brussel

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.

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 Timeline

• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-24
• Study Start: 2023-06-01
• Primary Completion: 2024-12-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-04-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 103

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Central senzitization CSI	12 weeks follow-up	Central sensitization inventory
Central sensitiszation QST	12 weeks follow-up	Quantitative sensory testing
Central sensitization PSQ	12 weeks follow-up	Pain sensitization questionnaire

Trial Locations

Locations (1)

Fysiomobilae; 🇳🇱 Zwolle, Overijssel, Netherlands