Skip to main content
Clinical Trials/NCT04974229
NCT04974229
Completed
Not Applicable

Sensory Profiles as Predictors of Central Sensitization in Low Back Pain: A Prospective Cohort Study.

Vrije Universiteit Brussel1 site in 1 country102 target enrollmentJanuary 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sensory Profiles
Sponsor
Vrije Universiteit Brussel
Enrollment
102
Locations
1
Primary Endpoint
Central Sensitization Inventory score
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
March 1, 2017
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pieter Graper

Principal Investigator

Vrije Universiteit Brussel

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

Outcomes

Primary Outcomes

Central Sensitization Inventory score

Time Frame: 12 weeks

The validated questionnaire Central Sensitization Inventory which scores on a 5 point scale ranging from 0-100. A higher score indicated a higher degree of central sensitization.

Adolescent/Adult Sensory Profile score

Time Frame: 0 weeks

Adolescent/Adult Sensory Profile measures 4 sensory profiles (sensation avoiding, sensation sensitive, sensation seeking, low registration) on ad 5 point scale, and is validated in the low back pain population. Scores range from 15-60 points per variable. A higher score means a higher degree of sensitivity for the specific sensory profile.

Secondary Outcomes

  • Numeric Pain Rating Scale score(Baseline (0 weeks))
  • Pain Disability Index score(Baseline (0 weeks))
  • age(Baseline (0 weeks))
  • duration of low back pain(Baseline (0 weeks))

Study Sites (1)

Loading locations...

Similar Trials