Prognostic Factor Research of Sensory Profiles in Development of Central Sensitization

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04974229
• Other study ID #: ProgCohSt-M15.169564
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: July 2021
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Central Sensitisation
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Belgium	Vrije universiteit Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Sensitization Inventory score	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
Primary	Adolescent/Adult Sensory Profile score	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	Numeric Pain Rating Scale score	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)
Secondary	Pain Disability Index score	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)
Secondary	age	The included age (years) ranged from 18-60 score. A higher age indicates a worse prognoses of low back pain.	Baseline (0 weeks)
Secondary	duration of low back pain	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)