Low Back PainLOBAFRACSNCT05231265
Effect of Lumbar Surgery on Complexity During a Walking Task in Chronic Low Back Pain
An observational study of Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
Lumbar surgery is the most common treatment for chronic disabling low back pain with degenerative disc disease. There are few elements to objectively evaluate the improvement of the motor control after surgery and the motor adaptation capacities of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Walking task
- How many people
- 32 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Oct 2023to Apr 2027
- 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: Patients with chronic low back pain requiring prosthesis or arthrodesis surgery for their lumbar pathology (surgery on one or two levels) followed at the Nîmes University Hospital or at the Grand Sud Polyclinic.
Who may be able to join
- Patients with chronic low back pain requiring prosthesis or arthrodesis surgery on one or two levels
- Subject affiliated or beneficiary of a health insurance plan.
- The patient must have given their free and informed consent
Who cannot join
- Patients with organic low back pain (infection, tumor, inflammatory rheumatism)
- Patient with a neurological deficit (cauda equina syndrome or motor testing MRC < 3 on a muscle group of the lower limbs)
- Patient who has already undergone lumbar surgery (except single discectomy)
- Patient with serious concomitant pathologies
- Patients participating in a therapeutic study prohibiting participation in another study
- Patient in an exclusion period from a different study
Show all 10Show fewer
- It is impossible to give the subject informed information
- Patient is unable to express consent
- The patient is under safeguard of justice or state guardianship
- Patient is pregnant, parturient or breastfeeding
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU Nîmes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Alexis Homs
- Not yet recruiting
Polyclinique Grand Sud
Nîmes
Sébastien Trincat, Sebastien.trincat@gmail.com
Sebastien.trincat@gmail.com Trincat
About this study
Official title: Effect of Lumbar Surgery on Complexity During a Walking Task in the Chronic Low Back Pain Patient
Lumbar surgery is the most common treatment for chronic disabling low back pain with degenerative disc disease. There are few elements to objectively evaluate the improvement of the motor control after surgery and the motor adaptation capacities of the patients.
The impact of lumbar surgery on complexity in this painful context has never been studied. Theoretically, the restriction of mobility imposed by lumbar surgery should limit the subject's adaptive capacities (of one or more lumbar segments) and thus reduce complexity. Nevertheless, improvement in pain intensity levels could allow the patient to find better motor adaptation capacities, necessary for a positive evolution in the long-term.
Read more
The aim of this study was to investigate the evolution of gait complexity in chronic low back pain patients pre- and post-surgery. If surgery improves the adaptability of walking through an antalgic benefit exceeding the induced stiffness, the complexity of walking should be superior after surgery.
This is a proof-of-concept study in which the study investigators hypothesize that measuring complexity by fractal analysis during a walking task will show the increase in gait complexity induced by lumbar surgery at 3 and 6 months after surgery.
- Conditions
- Low Back Pain
- Being tested
- Walking task
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking taskOther
Treadmill walking task with study of fractal variability (complexity) for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Low Back Pain | Not described Receives: Other: Walking task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait complexity
fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)
Measured: 10 days before surgery +/- 3 days
Gait complexity
fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)
Measured: Month 3
Gait complexity
fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)
Measured: Month 6
Secondary outcomes (12)
Patient reported pain
Visual analog scale (0-100)
Measured: 10 days before surgery +/- 3 days
Patient reported pain
Visual analog scale (0-100)
Measured: Month 3
Patient reported pain
Visual analog scale (0-100)
Measured: Month 6
Apprehension of pain of movement
Tampa Scale of Kinesiophobia. Score ranging from 17-68. Higher scores denote greater level of kinesiophobia (a score >40 is considered significant kinesiophobia)
Measured: 10 days before surgery +/- 3 days
Apprehension of pain of movement
Tampa Scale of Kinesiophobia. Score ranging from 17-68. Higher scores denote greater level of kinesiophobia (a score >40 is considered significant kinesiophobia)
Measured: Month 3
Apprehension of pain of movement
Tampa Scale of Kinesiophobia. Score ranging from 17-68. Higher scores denote greater level of kinesiophobia (a score >40 is considered significant kinesiophobia)
Measured: Month 6
Patient reported quality of life
EuroQol-5 Dimension questionnaire: results generated as 5 digit number corresponding to different aspects of quality of life
Measured: 10 days before surgery +/- 3 days
Patient reported quality of life
EuroQol-5 Dimension questionnaire: results generated as 5 digit number corresponding to different aspects of quality of life
Measured: Month 3
Patient reported quality of life
EuroQol-5 Dimension questionnaire: results generated as 5 digit number corresponding to different aspects of quality of life
Measured: Month 6
Correlation between type of surgery and gait variability
Classified as either arthrodesis or prosthesis
Measured: 10 days before surgery +/- 3 days
Correlation between type of surgery and gait variability
Classified as either arthrodesis or prosthesis
Measured: Month 3
Correlation between type of surgery and gait variability
Classified as either arthrodesis or prosthesis
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start16 Oct 2023
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Homs, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231265
- Sponsor's protocol ID
- NIMAO/2020-2/AH-2
- Acronym
- LOBAFRACS
- Status last verified
- May 2026
- First submitted
- 28 Jan 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lumbar Surgery on Complexity During a Walking Task in the Chronic Low Back Pain Patient
- ClinicalTrials.gov ID
- NCT05231265
- Acronym / sponsor ID
- LOBAFRACS / NIMAO/2020-2/AH-2
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 9 Feb 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.
Lumbar surgery is the most common treatment for chronic disabling low back pain with degenerative disc disease. There are few elements to objectively evaluate the improvement of the motor control after surgery and the motor adaptation capacities of the patients.
The impact of lumbar surgery on complexity in this painful context has never been studied. Theoretically, the restriction of mobility imposed by lumbar surgery should limit the subject's adaptive capacities (of one or more lumbar segments) and thus reduce complexity. Nevertheless, improvement in pain intensity levels could allow the patient to find better motor adaptation capacities, necessary for a positive evolution in the long-term.
The aim of this study was to investigate the evolution of gait complexity in chronic low back pain patients pre- and post-surgery. If surgery improves the adaptability of walking through an antalgic benefit exceeding the induced stiffness, the complexity of walking should be superior after surgery.
This is a proof-of-concept study in which the study investigators hypothesize that measuring complexity by fractal analysis during a walking task will show the increase in gait complexity induced by lumbar surgery at 3 and 6 months after surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Low Back Pain | – | Other: Walking task |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic low back pain requiring prosthesis or arthrodesis surgery for their lumbar pathology (surgery on one or two levels) followed at the Nîmes University Hospital or at the Grand Sud Polyclinic.
Key inclusion criteria (3 listed)
- Patients with chronic low back pain requiring prosthesis or arthrodesis surgery on one or two levels
- Subject affiliated or beneficiary of a health insurance plan.
- The patient must have given their free and informed consent
Key exclusion criteria (10 listed)
- Patients with organic low back pain (infection, tumor, inflammatory rheumatism)
- Patient with a neurological deficit (cauda equina syndrome or motor testing MRC < 3 on a muscle group of the lower limbs)
- Patient who has already undergone lumbar surgery (except single discectomy)
- Patient with serious concomitant pathologies
- Patients participating in a therapeutic study prohibiting participation in another study
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 |
|---|---|---|
| Walking taskTreadmill walking task with study of fractal variability (complexity) for 10 minutes. | Other | Patients with Low Back Pain |
Primary outcome
Gait complexity
Time frame: 10 days before surgery +/- 3 days
fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)
Gait complexity
Time frame: Month 3
fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)
Gait complexity
Time frame: Month 6
fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)
12 secondary outcomes
Patient reported pain
Time frame: 10 days before surgery +/- 3 days
Patient reported pain
Time frame: Month 3
Patient reported pain
Time frame: Month 6
Apprehension of pain of movement
Time frame: 10 days before surgery +/- 3 days
Apprehension of pain of movement
Time frame: Month 3
Apprehension of pain of movement
Time frame: Month 6
Patient reported quality of life
Time frame: 10 days before surgery +/- 3 days
Patient reported quality of life
Time frame: Month 3
Patient reported quality of life
Time frame: Month 6
Correlation between type of surgery and gait variability
Time frame: 10 days before surgery +/- 3 days
Correlation between type of surgery and gait variability
Time frame: Month 3
Correlation between type of surgery and gait variability
Time frame: Month 6
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 Jun 2026.
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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.
Alexis Homs principal investigator
CHU Nimes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 2 sites 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 10 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Alexis Homs (04.66.68.34.59, alexis.homs@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait complexity (time frame: 10 days before surgery +/- 3 days). 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 Jun 2026.