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

NCT ID: NCT05097235

Last Updated: 2023-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-05-31

Brief Summary

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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

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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.

Conditions

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Sensory Profiles, Nociplastic Pain, Low Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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t0, t1

acute low back pain, inclusion criteria.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vrije Universiteit Brussel

OTHER

Sponsor Role lead

Responsible Party

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Pieter Graper

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aldo Scafoglieri, PhD

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussel, Brussels, Belgium

Locations

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Fysiomobilae

Zwolle, Overijssel, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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T-3LoCoSt

Identifier Type: -

Identifier Source: org_study_id

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