Prognostic Factor Research of Sensory Profiles in Development of Central Sensitization

NCT ID: NCT04974229

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2017-03-01

Brief Summary

A longitudinal observational cohort study to investigate the value of prognostic factors, here sensory profiles , and others, in the development of central sensitization in the low back pain population. A type 2 prognostic factor research following the PROGRESS framework. Sensory profiles are identified a prognostic factors which can predict the development of central sensitization in the low back pain population.

Detailed Description

After performing an univariable linear regression analyses the regression model predicts the dependent variable, central sensitization, significantly, and the models are significant prediction factors of the development of central sensitization. In unadjusted analyses, all four sensory profiles were significantly associated with the development of central sensitization (P<0.001).

After adjusting for pain, disability, age, and duration of low back pain, baseline sensory profiles remained significant predictors of central sensitization. On the other hand, all other predictor variables did not contribute to the prediction of central sensitization.

Conditions

Sensory Profiles; Central Sensitisation; Low Back Pain; Nociplastic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

acute non-specific low back pain

patients with acute low back pain of (\< 6 weeks) were consecutively included with or without radiating pain, aged 18 to 60 years with a pain-free episode for at least 3 months before the onset of their current back pain. They were also required to be able to read and understand the Dutch language.

In line with the Dutch guideline for non-specific low back pain, Standard usual care for non-specific low back pain was applied.

Intervention Type: OTHER

In line with the Dutch guideline for non-specific low back pain, Standard usual care or non-specific low back pain was applied.

Interventions

In line with the Dutch guideline for non-specific low back pain, Standard usual care for non-specific low back pain was applied.

In line with the Dutch guideline for non-specific low back pain, Standard usual care or non-specific low back pain was applied.

Intervention Type: OTHER

Other Intervention Names

In line with the Dutch guideline for low back pain, Standard usual care or non-specific low back pain was applied.

Eligibility Criteria

Inclusion Criteria

• acute low back pain (< 6 weeks)
• with or without radiating pain
• aged 18 to 60 years
• a pain-free episode for at least 3 months before the onset of their current back pain
• read and understand the Dutch language.

Exclusion Criteria

• previous lumbar spinal surgery
• lumbar radicular syndrome
• specific cause of low back pain
• lumbar spinal stenosis
• current malignancy
• spondyloarthropathy
• osteoporosis
• spondylolisthesis
• major trauma
• infection
• systemic disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: lead

Responsible Party

Pieter Graper

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aldo Scafoglieri, PhD

Role: STUDY_DIRECTOR

VUB

Locations

Vrije universiteit Brussel

Brussels, , Belgium

Countries

Belgium

Other Identifiers

ProgCohSt-M15.169564

Identifier Type: -

Identifier Source: org_study_id