Sensory ProfilesNCT04974229
Prognostic Factor Research of Sensory Profiles in Development of Central Sensitization
An observational study of Sensory Profiles and Central Sensitisation, run by Vrije Universiteit Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Sensory Profiles, Central Sensitisation, Low Back Pain
- How many people
- 102 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2016to 1 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- previous lumbar spinal surgery
- lumbar radicular syndrome
- specific cause of low back pain
- lumbar spinal stenosis
- current malignancy
- spondyloarthropathy
Show all 11Show fewer
- osteoporosis
- spondylolisthesis
- major trauma
- infection
- systemic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- In line with the Dutch guideline for non-specific low back pain, Standard usual care for non-specific low back pain was applied.
- Keywords
- Prognostic factors research, Sensory Profiles, Central Sensitisation, Low back pain, Nociplastic Pain
- Medical subject headings
- Low Back Pain, Nociplastic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In line with the Dutch guideline for non-specific low back pain, Standard usual care for non-specific low back pain was applied.Other
Also called In line with the Dutch guideline for low back pain, Standard usual care or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: In line with the Dutch guideline for non-specific low back pain, Standard usual care for non-specific low back pain was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 0 weeks
Secondary outcomes (4)
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).
Measured: Baseline (0 weeks)
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.
Measured: Baseline (0 weeks)
age
The included age (years) ranged from 18-60 score. A higher age indicates a worse prognoses of low back pain.
Measured: Baseline (0 weeks)
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.
Measured: Baseline (0 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Jan 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory ProfilesStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pieter Graper, Vrije Universiteit Brussel
- Investigators
- Aldo Scafoglieri, PhD, Study director, VUB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974229
- Sponsor's protocol ID
- ProgCohSt-M15.169564
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Profiles as Predictors of Central Sensitization in Low Back Pain: A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT04974229
- Acronym / sponsor ID
- ProgCohSt-M15.169564
- Keywords
- Prognostic factors research, Sensory Profiles, Central Sensitisation, Low back pain, Nociplastic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute non-specific low back pain | – | Other: 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- previous lumbar spinal surgery
- lumbar radicular syndrome
- specific cause of low back pain
- lumbar spinal stenosis
- current malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In line with the Dutch guideline for non-specific low back pain, Standard usual care for non-specific low back pain was applied.Also: In line with the Dutch guideline for low back pain, Standard usual care or 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 | acute non-specific low back pain |
Primary outcome
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.
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.
4 secondary outcomes
Numeric Pain Rating Scale score
Time frame: Baseline (0 weeks)
Pain Disability Index score
Time frame: Baseline (0 weeks)
age
Time frame: Baseline (0 weeks)
duration of low back pain
Time frame: Baseline (0 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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Are Developmentally At Risky Babies Environmentally Disadvantaged?
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Nociplastic Pain Symptoms and Sensory Profiles in Low Back Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aldo Scafoglieri, PhD study director
VUB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensory Profiles and Central Sensitisation, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Sensitization Inventory score (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.