Type 3 Predictive Observational Study for Sensory Profiles in Central Sensitization in Low Back Pain Population.

Completed

• Conditions: Sensory Profiles, Nociplastic Pain, Low Back Pain

• Registration Number: NCT05097235
• Lead Sponsor: Vrije Universiteit Brussel

Brief Summary

This study conducts prognostic research to develop, validate, and evaluate the predictive role of sensory profiles in the development of sensory profiles over time. Therefore, a type 3 prognostic model research will be conducted in the low back pain population.

Detailed Description

This is a longitudinal multi-centre prospective cohort study design with two measurements.The STROBE statement is used as guideline and the results are reported according to the TRIPOD, and REMARK checklists. The study is a type III prognostic model research study, following the PROGRESS framework to assess the outcome by the development, validation, and evaluation of the impact of incorporating single or multiple prognostic factors, and their prognostic value at baseline in the development of CS over a period of 12 weeks.

Study Timeline

• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-10-28
• Study Start: 2022-05-01
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-11
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• patients with acute LBP (< six weeks)
• with or without radiating pain
• aged 18 to 60 years
• a pain-free episode for at least 12 weeks before the onset of their current back pain.
• be able to read and understand the Dutch language.

Exclusion Criteria

• any specific cause of low back pain

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Central Sensitization Inventory	12 weeks	Central Sensitization Inventory (CSI) is a questionnaire which consists of 2 parts. Part A measures 25 symptoms on a 5-point scale, scoring ranges from 0-4, with a total on an ordinal scale ranging from 0-100. Part B records the presence diagnosed central sensitization syndromes, on a nominal scale. Four factors with excellent internal consistency (Cronbach's alpha= 0.91) can be identified: disability and physical symptoms; higher central sensitivity; urological and dermatological symptoms and emotional distress. The CSI has an excellent test-retest reliability of ICC=0.88 in chronic low back pain populations.

Trial Locations

Locations (1)

Fysiomobilae; 🇳🇱 Zwolle, Overijssel, Netherlands