Type 3 Predictive Observational Study for Sensory Profiles in Central Sensitization in Low Back Pain Population. (T3PredCohSt)

Type III PROGRESS Framework for Prognosis Research: Building Prognostic Models for Sensory Profiles in the Development of Central Sensitisation in the Chronic Low Back Pain Population

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8014XE
      • Fysiomobilae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

-primary physiotherapy practices in the Netherlands.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
t0, t1; acute low back pain, inclusion criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Sensitization Inventory	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.	12 weeks

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel
• Investigators: Principal Investigator: Aldo Scafoglieri, PhD, Vrije Universiteit Brussel, Brussels, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: sensory profiles, central sensitization, low back pain.
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: T-3LoCoSt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No