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NCT Number: NCT04974229

Prognostic Factor Research of Sensory Profiles in Development of Central Sensitization

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.

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Key information

Conditions

Sensory Profiles Back Pain Central Sensitisation Low Back Pain Neurologic Manifestations Nociplastic Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vrije universiteit Brussel

Brussels, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

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

Primary outcomes

  1. 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.

  2. 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

  1. 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).

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 23, 2021
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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