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Completed

NCT Number: NCT05097235

Type 3 Predictive Observational Study for Sensory Profiles in Central Sensitization in 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.

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Key information

Conditions

Sensory Profiles, Nociplastic Pain, Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Nociplastic Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fysiomobilae

Zwolle, Overijssel, 8014XE, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Central Sensitization Inventory

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

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

Acronym: T3PredCohSt

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2021
Registry last updated
Jun 13, 2023

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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