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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05097235

Acronym

T3PredCohSt

Enrollment

114

Registered

2021-10-28

Start date

2022-05-01

Completion date

2023-05-31

Last updated

2023-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensory Profiles, Nociplastic Pain, Low Back Pain

Keywords

sensory profiles, central sensitization, low back pain.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Netherlands

Outcome results