Sensory Profiles, Nociplastic Pain, Low Back PainT3PredCohStNCT05097235
Type 3 Predictive Observational Study for Sensory Profiles in Central Sensitization in Low Back Pain Population.
An observational study of Sensory Profiles, Nociplastic Pain, Low Back Pain, run by Vrije Universiteit Brussel at 1 site in Netherlands.
Trial summary
This study conducts prognostic research to develop, validate, and evaluate the predictive role of sensory profiles in the development of sensory profiles over time. Therefore, a type 3 prognostic model research will be conducted in the low back pain population. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sensory Profiles, Nociplastic Pain, Low Back Pain
- How many people
- 114 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2022to 31 May 2023
- How long will I take part?
- 12 Weeks
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: -primary physiotherapy practices in the Netherlands.
Who may be able to join
- patients with acute LBP (< six weeks)
- with or without radiating pain
- aged 18 to 60 years
- a pain-free episode for at least 12 weeks before the onset of their current back pain.
- be able to read and understand the Dutch language.
Who cannot join
- any specific cause of low back pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Type III PROGRESS Framework for Prognosis Research: Building Prognostic Models for Sensory Profiles in the Development of Central Sensitisation in the Chronic Low Back Pain Population
This study conducts prognostic research to develop, validate, and evaluate the predictive role of sensory profiles in the development of sensory profiles over time. Therefore, a type 3 prognostic model research will be conducted in the low back pain population.
Read the detailed description
This is a longitudinal multi-centre prospective cohort study design with two measurements.The STROBE statement is used as guideline and the results are reported according to the TRIPOD, and REMARK checklists. The study is a type III prognostic model research study, following the PROGRESS framework to assess the outcome by the development, validation, and evaluation of the impact of incorporating single or multiple prognostic factors, and their prognostic value at baseline in the development of CS over a period of 12 weeks.
- Keywords
- sensory profiles, central sensitization, low back pain.
- Medical subject headings
- Nociplastic Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| t0, t1 | acute low back pain, inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Sensitization Inventory
Central Sensitization Inventory (CSI) is a questionnaire which consists of 2 parts. Part A measures 25 symptoms on a 5-point scale, scoring ranges from 0-4, with a total on an ordinal scale ranging from 0-100. Part B records the presence diagnosed central sensitization syndromes, on a nominal scale. Four factors with excellent internal consistency (Cronbach's alpha= 0.91) can be identified: disability and physical symptoms; higher central sensitivity; urological and dermatological symptoms and emotional distress. The CSI has an excellent test-retest reliability of ICC=0.88 in chronic low back pain populations.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 May 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Profiles, Nociplastic Pain, Low Back PainStudies of the same condition, open and under way.
- 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
- 114 participants (actual)
- 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, Principal investigator, Vrije Universiteit Brussel, Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097235
- Sponsor's protocol ID
- T-3LoCoSt
- Acronym
- T3PredCohSt
- Status last verified
- Jun 2023
- First submitted
- 13 Oct 2021
- Last updated
- 13 Jun 2023
- Results posted
- No
- 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 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type III PROGRESS Framework for Prognosis Research: Building Prognostic Models for Sensory Profiles in the Development of Central Sensitisation in the Chronic Low Back Pain Population
- ClinicalTrials.gov ID
- NCT05097235
- Acronym / sponsor ID
- T3PredCohSt / T-3LoCoSt
- Keywords
- sensory profiles, central sensitization, low back pain.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 28 Oct 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.
This study conducts prognostic research to develop, validate, and evaluate the predictive role of sensory profiles in the development of sensory profiles over time. Therefore, a type 3 prognostic model research will be conducted in the low back pain population.
Detailed description
This is a longitudinal multi-centre prospective cohort study design with two measurements.The STROBE statement is used as guideline and the results are reported according to the TRIPOD, and REMARK checklists. The study is a type III prognostic model research study, following the PROGRESS framework to assess the outcome by the development, validation, and evaluation of the impact of incorporating single or multiple prognostic factors, and their prognostic value at baseline in the development of CS over a period of 12 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| t0, t1 | – | –acute low back pain, inclusion criteria. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- -primary physiotherapy practices in the Netherlands.
Key inclusion criteria (5 listed)
- patients with acute LBP (< six weeks)
- with or without radiating pain
- aged 18 to 60 years
- a pain-free episode for at least 12 weeks before the onset of their current back pain.
- be able to read and understand the Dutch language.
Key exclusion criteria (1 listed)
- any specific cause of low back pain
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 Sensitization Inventory
Time frame: 12 weeks
Central Sensitization Inventory (CSI) is a questionnaire which consists of 2 parts. Part A measures 25 symptoms on a 5-point scale, scoring ranges from 0-4, with a total on an ordinal scale ranging from 0-100. Part B records the presence diagnosed central sensitization syndromes, on a nominal scale. Four factors with excellent internal consistency (Cronbach's alpha= 0.91) can be identified: disability and physical symptoms; higher central sensitivity; urological and dermatological symptoms and emotional distress. The CSI has an excellent test-retest reliability of ICC=0.88 in chronic low back pain populations.
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 13 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Sensory Profiles, Nociplastic Pain, Low Back Pain
Active, not recruitingObservational study
Nociplastic Pain Symptoms and Sensory Profiles in Low Back Pain
Central Sensitisation, Low Back Pain
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 principal investigator
Vrije Universiteit Brussel, Brussels, Belgium
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, Nociplastic Pain, 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 5 inclusion and 1 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 13 Jun 2023. 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?
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 (time frame: 12 weeks). 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 13 Jun 2023.