Prognostic Factor Research of Sensory Profiles in Development of Central Sensitization

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: March 1, 2017

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.

Interventions

  • Other: 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Numeric Pain Rating Scale score
    • Time Frame: Baseline (0 weeks)
    • Numeric Pain Rating Scale measures experienced level of pain, which consist of one question ranging van 0 (no pain)-10 (most extreme pain imaginable).
  • Pain Disability Index score
    • Time Frame: Baseline (0 weeks)
    • The Pain Disability Index evaluates the effect on seven life-related domains. Each domain is measured by 1 question, with a total of 7 questions, on an 11 point scale, from 0 (no disability) to 10 (completely disabled). Previously established reliability and internal consistency are acceptable in patients with chronic pain.
  • age
    • Time Frame: Baseline (0 weeks)
    • The included age (years) ranged from 18-60 score. A higher age indicates a worse prognoses of low back pain.
  • duration of low back pain
    • Time Frame: Baseline (0 weeks)
    • Duration of low back pain was assessed in weeks. The included duration of low back pain ranged from 0-6 weeks. A longer duration is not better or worse.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vrije Universiteit Brussel
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pieter Graper, Principal Investigator – Vrije Universiteit Brussel
  • Overall Official(s)
    • Aldo Scafoglieri, PhD, Study Director, VUB

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