Clinical trial NCT04974229: Prognostic Factor Research of Sensory Profiles in Development of Central Sensitization
Official title: Sensory Profiles as Predictors of Central Sensitization in Low Back Pain: A Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sensory Profiles
Central Sensitisation
Low Back Pain
Nociplastic Pain
Keywords: Prognostic factors research
Sensory Profiles
Central Sensitisation
Low back pain
Nociplastic Pain
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Central Sensitization Inventory score
timeFrame: 12 weeks
measure: Adolescent/Adult Sensory Profile score
timeFrame: 0 weeks
Secondary outcomes:
measure: Numeric Pain Rating Scale score
timeFrame: Baseline (0 weeks)
measure: Pain Disability Index score
timeFrame: Baseline (0 weeks)
measure: age
timeFrame: Baseline (0 weeks)
measure: duration of low back pain
timeFrame: Baseline (0 weeks)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Vrije universiteit Brussel
Study officials:
affiliation: VUB
name: Aldo Scafoglieri, PhD
role: STUDY_DIRECTOR
References: