Chronic Low Back PainCoDiLoBPNCT03633578
Complexity & Distraction in LBP
A study testing walk test in people with Chronic Low Back Pain and Gait, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Motor control, notably expressed through the complexity of the variability of the locomotor pattern, is disturbed at the central level by an apprehension of pain and movement, more than pain itself (or by biomechanical / structural damage of the spine) in chronic low back pain (cLBP) patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain, Gait, Motor Activity
- What is being tested?
- walk test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to 17 May 2018
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have his informed consent and signed the consent form.
- The patient must be affiliated or beneficiary of a health insurance plan
- The patient is at least 18 years old and under 75 years old
- Patients with common chronic low back pain for more than 6 months
Who cannot join
- The subject participates in another interventional study
- The subject is in an exclusion period determined by a previous study
- The subject is under the protection of justice, guardianship or curatorship
- The subject refuses to sign the consent
- It is impossible to inform the subject
- Chronic symptomatic low back pain (tumoral pathology, infectious, or progressive inflammatory)
- Unable to walk for more than 10 minutes (during interrogation)
- Lower limb pain (EVA lower limb (s) ≥ Lumbar EVA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Complexity and Pain in a Walking Task With Distraction in the Chronic Low Back Pain Patient by Fractal Analysis: Pilot Study
Motor control, notably expressed through the complexity of the variability of the locomotor pattern, is disturbed at the central level by an apprehension of pain and movement, more than pain itself (or by biomechanical / structural damage of the spine) in chronic low back pain (cLBP) patients.
The aim of this study is to control that variability is reduced during gait at comfortable level and to test that distraction can reduce pain avoidance and therefore increase variability in cLBP patients.
- Conditions
- Chronic Low Back Pain, Gait, Motor Activity
- Being tested
- walk test
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walk testBehavioural
The patient will have to walk on a treadmill in four different conditions:
- without distraction at preferential speed
- with distraction at preferential speed
- without distraction at the speed of 130% of the preferential speed
- with distraction at the speed of 130% of the preferential speed
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Patients are asked to walk ont a treadmill in four conditions: with and without distraction (virtual environment) and at different speed (comfortable vs high). Receives: Behavioral: walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the fractal exponent when walking without distraction at preferential speed
[0,5; 1,5]
Measured: Day 0
Estimation of the fractal exponent when walking with distraction at preferential speed
[0,5; 1,5]
Measured: Day 0
Estimation of the fractal exponent when walking without distraction at the speed of 130% of the preferential speed
[0,5; 1,5]
Measured: Day 0
Estimation of the fractal exponent when walking with distraction at the speed of 130% of the preferential speed
[0,5; 1,5]
Measured: Day 0
Secondary outcomes (13)
EVA after walking without distraction at preferential speed
[0; 100]
Measured: Day 0
EVA after walking with distraction at preferential speed
[0; 100]
Measured: Day 0
EVA after walking without distraction at the speed of 130% of the preferential speed
[0; 100]
Measured: Day 0
EVA after walking with distraction at the speed of 130% of the preferential speed
[0; 100]
Measured: Day 0
Reaction time to auditory stimuli without distraction at preferential speed
second
Measured: Day 0
Reaction time to auditory stimuli with distraction at preferential speed
second
Measured: Day 0
Reaction time to auditory stimuli without distraction at the speed of 130% of the preferential speed
second
Measured: Day 0
Reaction time to auditory stimuli with distraction at the speed of 130% of the preferential speed
second
Measured: Day 0
Tampa Scale for kinesophobia
The total score ranges between 17 and 68. A high value on the Tampa Scale for the "Tampa Scale for kinesophobia" indicates a high degree of kinesiophobia
Measured: Day 0
Dallas Pain Questionnaire for Back Pain
This questionnaire has been designed to give health care provider information as to how pain affects daily activities. It assesses the impact of low back pain (LBP) on four components (daily activities, work and leisure activities, anxiety/depression, and social interest) (expressed as a value between 0 and 100) of daily life.The higher the score, the more the low back pain has an impact on the quality of life.
Measured: Day 0
Quebec Back Pain Disability Index
The item scores were summed for a total score between 0 and 100, with higher numbers representing greater levels of disability.
Measured: Day 0
Fear Avoidance Belief Questionnaire (FABQ)
The Fear Avoidance Belief Questionnaire is a two-part questionnaire assessing fear, avoidance, and beliefs about professional activity and physical activity.
The FABQ physical activity score of 14 responds better to a cognitive/behavioral approach and de-emphasize the traditional pain specific treatment goals. The "Fear Avoidance Belief Questionnaire" Work score that is >18 has a decrease likelihood of success from a joint manipulation/mobilization treatment approach. The "Fear Avoidance Belief Questionnaire" Work score of 34 or greater increases the risk for prolonged disability and will most likely require a multi-disciplinary approach to treatment.
Measured: Day 0
Hospital and Anxiety Depression Scale
Score:
0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Apr 2018
- Primary completion17 May 2018
- Study completion17 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Dupeyron, Pr, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633578
- Sponsor's protocol ID
- LOCAL/2017/AH-01
- Other IDs
- 2017-A02839-44
- Acronym
- CoDiLoBP
- Status last verified
- Dec 2020
- First submitted
- 14 Aug 2018
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Homs AF, Dupeyron A, Torre K. Relationship between gait complexity and pain attention in chronic low back pain. Pain. 2022 Jan 1;163(1):e31-e39. doi: 10.1097/j.pain.0000000000002303.
PubMed 34001770
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Complexity and Pain in a Walking Task With Distraction in the Chronic Low Back Pain Patient by Fractal Analysis: Pilot Study
- ClinicalTrials.gov ID
- NCT03633578
- Acronym / sponsor ID
- CoDiLoBP / LOCAL/2017/AH-01
- Conditions
- Chronic Low Back Pain, Gait, Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 17 May 2018 (actual)
- Study completion
- 17 May 2018 (actual)
- First posted
- 16 Aug 2018 (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.
Motor control, notably expressed through the complexity of the variability of the locomotor pattern, is disturbed at the central level by an apprehension of pain and movement, more than pain itself (or by biomechanical / structural damage of the spine) in chronic low back pain (cLBP) patients.
The aim of this study is to control that variability is reduced during gait at comfortable level and to test that distraction can reduce pain avoidance and therefore increase variability in cLBP patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Behavioral: walk testPatients are asked to walk ont a treadmill in four conditions: with and without distraction (virtual environment) and at different speed (comfortable vs high). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have his informed consent and signed the consent form.
- The patient must be affiliated or beneficiary of a health insurance plan
- The patient is at least 18 years old and under 75 years old
- Patients with common chronic low back pain for more than 6 months
Key exclusion criteria (8 listed)
- The subject participates in another interventional study
- The subject is in an exclusion period determined by a previous study
- The subject is under the protection of justice, guardianship or curatorship
- The subject refuses to sign the consent
- It is impossible to inform the subject
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 |
|---|---|---|
| walk testThe patient will have to walk on a treadmill in four different conditions: * without distraction at preferential speed * with distraction at preferential speed * without distraction at the speed of 130% of the preferential speed * with distraction at the speed of 130% of the preferential speed | Behavioural | Interventional group |
Primary outcome
Estimation of the fractal exponent when walking without distraction at preferential speed
Time frame: Day 0
[0,5; 1,5]
Estimation of the fractal exponent when walking with distraction at preferential speed
Time frame: Day 0
[0,5; 1,5]
Estimation of the fractal exponent when walking without distraction at the speed of 130% of the preferential speed
Time frame: Day 0
[0,5; 1,5]
Estimation of the fractal exponent when walking with distraction at the speed of 130% of the preferential speed
Time frame: Day 0
[0,5; 1,5]
13 secondary outcomes
EVA after walking without distraction at preferential speed
Time frame: Day 0
EVA after walking with distraction at preferential speed
Time frame: Day 0
EVA after walking without distraction at the speed of 130% of the preferential speed
Time frame: Day 0
EVA after walking with distraction at the speed of 130% of the preferential speed
Time frame: Day 0
Reaction time to auditory stimuli without distraction at preferential speed
Time frame: Day 0
Reaction time to auditory stimuli with distraction at preferential speed
Time frame: Day 0
Reaction time to auditory stimuli without distraction at the speed of 130% of the preferential speed
Time frame: Day 0
Reaction time to auditory stimuli with distraction at the speed of 130% of the preferential speed
Time frame: Day 0
Tampa Scale for kinesophobia
Time frame: Day 0
Dallas Pain Questionnaire for Back Pain
Time frame: Day 0
Quebec Back Pain Disability Index
Time frame: Day 0
Fear Avoidance Belief Questionnaire (FABQ)
Time frame: Day 0
Hospital and Anxiety Depression Scale
Time frame: Day 0
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 21 Nov 2025.
- Results publication: PubMed 34001770Homs AF, Dupeyron A, Torre K. Relationship between gait complexity and pain attention in chronic low back pain. Pain. 2022 Jan 1;163(1):e31-e39. doi: 10.1097/j.pain.0000000000002303.
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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.
Arnaud Dupeyron, Pr principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walk test in people with Chronic Low Back Pain and Gait, run by Centre Hospitalier Universitaire de Nīmes 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 4 inclusion and 8 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 21 Nov 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?
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?
Estimation of the fractal exponent when walking without distraction at preferential speed (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03633578, which also lists 1 linked publication.
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 21 Nov 2025.