Central SensitisationNCT05592405
Nociplastic Pain Symptoms and Sensory Profiles in Low Back Pain
An observational study of Central Sensitisation and Low Back Pain, run by Vrije Universiteit Brussel at 1 site in Netherlands.
Trial summary
Assessing associations between Sensory profiles and nociplastic pain symptoms, and assessing the prognostic value of sensory profiles in the development of nociplastic pain symptoms in a low back pain population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Central Sensitisation, Low Back Pain
- How many people
- 103 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2023to 1 Dec 2025
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Evaluation of eligibility will take place during assessment when the participant reports in primary care physiotherapy practice for the treatment of LBP. Patients will be included consecutively and measurements will be obtained by the investigator.
Who may be able to join
- patients with non-specific LBP
- with or without radiating pain
- aged 18-65 years
- able to read and understand the Dutch language
Who cannot join
- previous lumbar spinal surgery
- radiculopathy or any specific cause of low back pain such as lumbar spinal stenosis, current malignancy, spondyloarthropathy, osteoporosis, spondylolisthesis, major trauma, infection, or systemic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nociplastic Pain Measurement and Sensory Profiles in Patients with Acute and Chronic Low Back Pain: a Longitudinal Observational Cohort Study
Assessing associations between Sensory profiles and nociplastic pain symptoms, and assessing the prognostic value of sensory profiles in the development of nociplastic pain symptoms in a low back pain population.
Read the detailed description
Therefore, the investigators aims are:
- The primary aim of the study is to assess associations between Sensory Profiles (Adolescent/Adult Sensory Profiles) and Nociplastic pain Symptoms, in the acute and chronic low back pain population.
- The secondary aim is to assess the prognostic value of sensory profiles in the transition to central sensitisation and pain, in the acute and chronic low back pain population at twelve weeks.
- Conditions
- Central Sensitisation, Low Back Pain
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Central sensitiszation QST
Quantitative sensory testing
Measured: 12 weeks follow-up
Central senzitization CSI
Central sensitization inventory
Measured: 12 weeks follow-up
Central sensitization PSQ
Pain sensitization questionnaire
Measured: 12 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 Jun 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central SensitisationStudies 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
- Prospective
- Enrolment
- 103 participants (estimated)
- Target duration
- 12 Weeks
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, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592405
- Sponsor's protocol ID
- QST_SPs
- Status last verified
- Mar 2025
- First submitted
- 19 Oct 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing is unlikely as the data set includes pseudo-anominizised highly confidential data, of which the participants do not gave their consent to use their provided data.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nociplastic Pain Measurement and Sensory Profiles in Patients with Acute and Chronic Low Back Pain: a Longitudinal Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05592405
- Acronym / sponsor ID
- QST_SPs
- Conditions
- Central Sensitisation, Low Back Pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 24 Oct 2022 (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.
Assessing associations between Sensory profiles and nociplastic pain symptoms, and assessing the prognostic value of sensory profiles in the development of nociplastic pain symptoms in a low back pain population.
Detailed description
Therefore, the investigators aims are:
- The primary aim of the study is to assess associations between Sensory Profiles (Adolescent/Adult Sensory Profiles) and Nociplastic pain Symptoms, in the acute and chronic low back pain population.
- The secondary aim is to assess the prognostic value of sensory profiles in the transition to central sensitisation and pain, in the acute and chronic low back pain population at twelve weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Evaluation of eligibility will take place during assessment when the participant reports in primary care physiotherapy practice for the treatment of LBP. Patients will be included consecutively and measurements will be obtained by the investigator.
Key inclusion criteria (4 listed)
- patients with non-specific LBP
- with or without radiating pain
- aged 18-65 years
- able to read and understand the Dutch language
Key exclusion criteria (2 listed)
- previous lumbar spinal surgery
- radiculopathy or any specific cause of low back pain such as lumbar spinal stenosis, current malignancy, spondyloarthropathy, osteoporosis, spondylolisthesis, major trauma, infection, or systemic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Central sensitiszation QST
Time frame: 12 weeks follow-up
Quantitative sensory testing
Central senzitization CSI
Time frame: 12 weeks follow-up
Central sensitization inventory
Central sensitization PSQ
Time frame: 12 weeks follow-up
Pain sensitization questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: Undecided. Sharing is unlikely as the data set includes pseudo-anominizised highly confidential data, of which the participants do not gave their consent to use their provided data.
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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
Vrije Universiteit Brussel
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 Central Sensitisation and Low Back Pain, run by Vrije Universiteit Brussel at 1 site in Netherlands.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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 sensitiszation QST (time frame: 12 weeks follow-up). The study lists 3 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 1 Apr 2025.