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Prognostic Factor Research of Sensory Profiles in Development of Central Sensitization

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04974229
Enrollment
102
Registered
2021-07-23
Start date
2016-01-01
Completion date
2017-03-01
Last updated
2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Sensitisation, Low Back Pain, Nociplastic Pain, Sensory Profiles

Keywords

Prognostic factors research, Sensory Profiles, Central Sensitisation, Low back pain, Nociplastic Pain

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.

Interventions

OTHERIn 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.

Sponsors

Vrije Universiteit Brussel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Central Sensitization Inventory score12 weeksThe 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 score0 weeksAdolescent/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

MeasureTime frameDescription
Numeric Pain Rating Scale scoreBaseline (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 scoreBaseline (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.
ageBaseline (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 painBaseline (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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026