Chronic Low Back PainAPLOMBNCT05540548
Contribution of the Podiatrist-Posturologist in the Evaluation of the Link Between the Stabilometric Parameters and the Pain Felt in Patients With Chronic Low Back Pain
An observational study of Chronic Low Back Pain, run by University Hospital, Lille at 1 site in France.
Trial summary
Chronic low back pain is one of the major causes of disability worldwide. Knowledge about the pathophysiology of low back pain is insufficient, and an accurate diagnosis can only be obtained in 10 to 15% of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- How many people
- 139 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2024to 11 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients will be recruited within the pain unit of the General Hospital of Valenciennes, within the framework of the multidisciplinary consultation of the optimized pain and dedicated to the low back pain patients, where intervene a neurosurgeon algologist and a podiatrist posturologist. The selection of patients enrolled in the multidisciplinary pain consultation dedicated to low back pain patients will be reviewed by the Clinical Study Technician (screening) and checked by the principal investigator before the newsletter is sent.
Who may be able to join
- Suffering from low back pain, possibly associated with painful gluteal radiation in the form of mono or bilateral pygalgia (non-radicular) evolving for at least three months (chronic low back pain
- Understanding and being able to express himself in French
- Giving informed, dated and signed consent
Who cannot join
- Neurosurgical criteria: (i) presence of clinical signs of compression and/or single or multi-root pain (Lumbosciatica with or without deficit signs, intermittent claudication of the cauda equina roots with possible sphincter signs), (ii) history inflammatory arthropathy (ankylosing spondylitis, rheumatoid arthritis), and (iii) history of lumbar spine surgery.
- Radiographic criteria: (i) presence on the lumbar MRI of multi-level discopathy (more than 2 discopathy), (ii) spinal instability confirmed by CT or MRI (degenerative spondylolisthesis or by isthmic lysis).
- Pregnant or breastfeeding women
- Visually impaired patient
- Patient suffering from neurological and/or orthopedic disorders that may affect balance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de neurologie CH de Valenciennes
Valenciennes, 59300
Annarita Mora
About this study
Chronic low back pain is one of the major causes of disability worldwide. Knowledge about the pathophysiology of low back pain is insufficient, and an accurate diagnosis can only be obtained in 10 to 15% of cases. The absence of a precise diagnosis leads to a therapeutic challenge due to the large number of treatments available, the overall efficacy of which is low to moderate. Therefore, the identification of subgroups of non-specific chronic low back pain patients is essential and will allow the optimization of therapeutic management. A detailed description of the stabilometric parameters associated with the evaluation of pain, kinematic disturbance and the degree of kinesiophobia would allow us to establish specific postural profiles, to propose a relevant clinical model and to improve the accuracy of the diagnosis of people with chronic low back pain. The objectives of this research project are to evaluate the relationship between stabilometric parameters and pain (main objective), lumbar kinematics, kinesiophobia, and quality of life (secondary objectives) in order to propose specific postural profiles in chronic low back pain patients.
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic low back pain, Kinesiophobia, Pain, Posturology, Stabilometry
- Medical subject headings
- Kinesiophobia, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the average speed of displacement of the center of pressure measured in the open-eyes position and the level of pain felt in patients suffering from chronic low back pain
Measured: Baseline
Secondary outcomes (4)
Correlation between the other stabilometric parameters (mean surface, mean frontal and sagittal position) of postural stability measured in the open-eyes position and the level of pain felt.
Measured: Baseline
Correlation between the stabilometric parameters (mean speed, mean surface, mean frontal and sagittal position) of postural stability (measured in the open-eyes position and in the closed-eyes position) and neuropathic pain
Measured: Baseline
Correlation of stabilometric parameters (mean speed, mean surface, mean frontal and sagittal position) of postural stability (measured in open-eyes and closed-eyes position) with the degree of kinesiophobia and quality of life.
Measured: Baseline
Reproducibility of the stabilometric measurements (average speed, average surface, average frontal and sagittal position) in each of the conditions (in the open-eyes position and in the closed-eyes position).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start11 Jun 2024
- Primary completion11 Jun 2026 (estimated)
- Study completion11 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric VISEUX, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540548
- Sponsor's protocol ID
- 2021_0522
- Other IDs
- 2022-A00253-40
- Acronym
- APLOMB
- Status last verified
- Aug 2025
- First submitted
- 12 Sep 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of the Podiatrist-Posturologist in the Evaluation of the Link Between the Stabilometric Parameters and the Pain Felt in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05540548
- Acronym / sponsor ID
- APLOMB / 2021_0522
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic low back pain, Kinesiophobia, Pain, Posturology, Stabilometry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 11 Jun 2026 (estimated)
- Study completion
- 11 Jun 2026 (estimated)
- First posted
- 14 Sep 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.
Chronic low back pain is one of the major causes of disability worldwide. Knowledge about the pathophysiology of low back pain is insufficient, and an accurate diagnosis can only be obtained in 10 to 15% of cases. The absence of a precise diagnosis leads to a therapeutic challenge due to the large number of treatments available, the overall efficacy of which is low to moderate. Therefore, the identification of subgroups of non-specific chronic low back pain patients is essential and will allow the optimization of therapeutic management. A detailed description of the stabilometric parameters associated with the evaluation of pain, kinematic disturbance and the degree of kinesiophobia would allow us to establish specific postural profiles, to propose a relevant clinical model and to improve the accuracy of the diagnosis of people with chronic low back pain. The objectives of this research project are to evaluate the relationship between stabilometric parameters and pain (main objective), lumbar kinematics, kinesiophobia, and quality of life (secondary objectives) in order to propose specific postural profiles in chronic low back pain patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be recruited within the pain unit of the General Hospital of Valenciennes, within the framework of the multidisciplinary consultation of the optimized pain and dedicated to the low back pain patients, where intervene a neurosurgeon algologist and a podiatrist posturologist. The selection of patients enrolled in the multidisciplinary pain consultation dedicated to low back pain patients will be reviewed by the Clinical Study Technician (screening) and checked by the principal investigator before the newsletter is sent.
Key inclusion criteria (3 listed)
- Suffering from low back pain, possibly associated with painful gluteal radiation in the form of mono or bilateral pygalgia (non-radicular) evolving for at least three months (chronic low back pain
- Understanding and being able to express himself in French
- Giving informed, dated and signed consent
Key exclusion criteria (5 listed)
- Neurosurgical criteria: (i) presence of clinical signs of compression and/or single or multi-root pain (Lumbosciatica with or without deficit signs, intermittent claudication of the cauda equina roots with possible sphincter signs), (ii) history inflammatory arthropathy (ankylosing spondylitis, rheumatoid arthritis), and (iii) history of lumbar spine surgery.
- Radiographic criteria: (i) presence on the lumbar MRI of multi-level discopathy (more than 2 discopathy), (ii) spinal instability confirmed by CT or MRI (degenerative spondylolisthesis or by isthmic lysis).
- Pregnant or breastfeeding women
- Visually impaired patient
- Patient suffering from neurological and/or orthopedic disorders that may affect balance.
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
Correlation between the average speed of displacement of the center of pressure measured in the open-eyes position and the level of pain felt in patients suffering from chronic low back pain
Time frame: Baseline
4 secondary outcomes
Correlation between the other stabilometric parameters (mean surface, mean frontal and sagittal position) of postural stability measured in the open-eyes position and the level of pain felt.
Time frame: Baseline
Correlation between the stabilometric parameters (mean speed, mean surface, mean frontal and sagittal position) of postural stability (measured in the open-eyes position and in the closed-eyes position) and neuropathic pain
Time frame: Baseline
Correlation of stabilometric parameters (mean speed, mean surface, mean frontal and sagittal position) of postural stability (measured in open-eyes and closed-eyes position) with the degree of kinesiophobia and quality of life.
Time frame: Baseline
Reproducibility of the stabilometric measurements (average speed, average surface, average frontal and sagittal position) in each of the conditions (in the open-eyes position and in the closed-eyes position).
Time frame: Baseline
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 24 Aug 2025.
Related trials for Chronic 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.
Frédéric VISEUX principal investigator
University Hospital, Lille
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 Chronic Low Back Pain, run by University Hospital, Lille at 1 site in France.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Aug 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 France. 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?
Contact Frédéric VISEUX (03 27 14 04 54 ext. +33, viseux-f@ch-valenciennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the average speed of displacement of the center of pressure measured in the open-eyes position and the level of pain felt in patients suffering from chronic low back pain (time frame: Baseline). 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 24 Aug 2025.