Prognostic Factor Research of Sensory Profiles in Development of Central Sensitization

Completed

• Conditions: Nociplastic Pain; Central Sensitisation; Sensory Profiles; Low Back Pain
• 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.

• Registration Number: NCT04974229
• Lead Sponsor: Vrije Universiteit Brussel

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-21
• Last Update Submitted: 2021-07-21
• Study First Posted: 2021-07-23
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Central Sensitization Inventory score	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	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 Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale score	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	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	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	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.

Trial Locations

Locations (1)

Vrije universiteit Brussel; 🇧🇪 Brussels, Belgium