Prognostic Factor Research of Sensory Profiles in Development of Central Sensitization

July 21, 2021 updated by: Pieter Graper, Vrije Universiteit Brussel

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Vrije Universiteit Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants were recruited primary care physiotherapy practices randomly spread throughout the Netherlands. Participants with acute low back pain were consecutively included by physiotherapists.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • In line with the Dutch guideline for low back pain, Standard usual care or non-specific low back pain was applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
0 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (0 weeks)
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.
Baseline (0 weeks)
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.
Baseline (0 weeks)
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.
Baseline (0 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vrije Universiteit Brussel

Investigators

  • Study Director: Aldo Scafoglieri, PhD, VUB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProgCohSt-M15.169564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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