Non-specific Chronic Low Back PainICORNCT06669767
Behavioral Indicators of Pain Representation
An observational study of Non-specific Chronic Low Back Pain and Healthy Volunteer, run by Universite de Picardie Jules Verne at 1 site in France.
Trial summary
The goal of this observational study is to compare the postural response to the mental simulation of everyday situations identified as painful in participants with non-specific low back pain and healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-specific Chronic Low Back Pain, Healthy Volunteer
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2024to 6 Jun 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: General population
Who may be able to join
- Age between 18 and 55
- Non-specific chronic low back pain for the concerned group
Who cannot join
- Low back pain for 0 to 3 months
- Unable to stand 1 minute without technical aid
- Neurological, motor or cognitive know impairment
- BMI > 30
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to compare the postural response to the mental simulation of everyday situations identified as painful in participants with non-specific low back pain and healthy volunteers.
The main questions it aims to answer are :
Do participants with low-back pain show reduced variability in center of pressure displacements compared with non-painful participants when faced with mental simulation of everyday situations identified as painful? Is the postural response correlated with the level of kinesiophobia? Participants will be faced to pictures of everyday situations identified as painful while several physiological measurements (posturography, electromyography, heart rate) are being recorded.
- Keywords
- Kinesiophobia, Low back pain, Posturography
- Medical subject headings
- Kinesiophobia, 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 |
|---|---|---|
| Non-specific chronic low back pain | Participants with non-specific chronic low back pain (>3 months). | |
| Control group | Healthy volunteers, without any low back pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard deviation of the position of the center of pressure on the anteroposterior axis (SD-COP-AP)
Movements of the center of pressure (COP) are recorded using a force plate, and the SD-COP-AP is calculated after recording and is an indicator of the postural response.
Measured: Baseline
Secondary outcomes (26)
Mean position of the center of pressure on the anteroposterior axis (COP-AP)
Measured: Baseline
Mean position of the center of pressure on the mediolateral axis (COP-ML)
Measured: Baseline
Standard deviation of the position of the center of pressure on the mediolateral axis (SD-COP-ML)
Measured: Baseline
Sway length of the center of pressure on the anteroposterior axis (L-COP-AP)
Measured: Baseline
Sway length of the center of pressure on the mediolateral axis (L-COP-ML)
Measured: Baseline
Tibialis anterior muscle activity
Measured by electromyography, RMS normalized to maximum voluntary contraction.
Measured: Baseline
Soleus muscle activity
Measured by electromyography, RMS normalized to maximum voluntary contraction.
Measured: Baseline
Longissimus dorsi muscle activity
Measured by electromyography, RMS normalized to maximum voluntary contraction.
Measured: Baseline
Co-activation (Soleus/Tibialis anterior)
Measured: Baseline
Coefficient of variation for muscle activity of tibialis anterior
Measured: Baseline
Coefficient of variation for muscle activity of soleus
Measured: Baseline
Coefficient of variation for muscle activity of longissimus dorsi
Measured: Baseline
Mean heart rate
Measured: Baseline
Mean RR interval
Measured: Baseline
Standard deviation of normal RR intervals (SDNN)
Measured: Baseline
Root mean square of successive R-R intervals (RMSSD)
Measured: Baseline
Power of very low frequency from frequency analysis (VLF)
Measured: Baseline
Power of low frequency from frequency analysis (LF)
Measured: Baseline
Power of high frequency from frequency analysis (HF)
Measured: Baseline
Ratio of LF/HF (post-frequency analysis)
Measured: Baseline
Tampa scale for kinesiophobia (TSK) score
Kinesiophobia was evaluated with the Tampa Scale for Kinesiophobia (TSK), a self-administered questionnaire validated in French. The TSK measures the fear of movement and is used in various painful conditions. It includes 17 items evaluated on a 4-point Likert scale. The total score range is 17-68 and a high score indicates a greater fear of movement.
Measured: Baseline
Brief pain inventory (BPI) score
Pain was assessed with the Brief Pain Inventory (BPI), a reliable self-administered questionnaire about pain severity (4 items) and interference with daily living (7 items) validated in French. Each item is evaluated on a numerical scale from 0 to 10. A high score indicates significant pain or significant interference in daily living.
Measured: Baseline
EQ-5D-5L questionnaire score
The EQ-5D-5L is a standardized questionnaire used as a measure of health-related quality of life. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression, on a five-level scale (no problem, slight problems, moderate problems, severe problems, unable to). The second part consist in a visual analogic scale about global health of the participant and provide a value from 0 to 100 with high value representing a good health.
Measured: Baseline
Fear-Avoidance Component Scale (FACS) score
The fear-avoidance component scale is used to measure the major fear-avoidance signs in painful conditions. It includes 20 items evaluated on a 5-point Likert scale. The total score is from 0 to 100 with 5 severity levels: 0-20 subclinical, 21-40 low, 41-60 moderate, 61-80 severe, and extreme 81-100.
Measured: Baseline
Pain catastrophizing scale (PCS) score
Catastrophism was evaluated with the pain catastrophizing scale. It includes 13 items evaluated on a 4-point Likert scale and divided into 3 dimensions: magnification, rumination, and helplessness. A high score corresponds to a high level of catastrophism. The total score ranges from 0 to 52 with a cut-off score of 30 for a significant catastrophism level.
Measured: Baseline
Hospital Anxiety and Depression scale (HAD) score
The Hospital Anxiety and Depression scale (HAD) includes 14 items, 7 for anxiety and 7 for depression validated in French. Each item is rated from 0 to 3 and the scores for each dimension range from 0 to 21. Cut-off scores were established with 8-10 being uncertain symptomatology and above 10 being definite symptomatology.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start14 Nov 2024
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universite de Picardie Jules Verne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrien Hakimi, Universite de Picardie Jules Verne
- Investigators
- Thierry LELARD, PhD, Study director, Universite de Picardie Jules Verne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669767
- Sponsor's protocol ID
- IRB00012476_2024_10_07_328
- Acronym
- ICOR
- Status last verified
- Aug 2025
- First submitted
- 28 Oct 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Indicators of Pain Representation
- ClinicalTrials.gov ID
- NCT06669767
- Acronym / sponsor ID
- ICOR / IRB00012476_2024_10_07_328
- Keywords
- Kinesiophobia, Low back pain, Posturography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universite de Picardie Jules VerneUniversity, hospital or other
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 1 Nov 2024 (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.
The goal of this observational study is to compare the postural response to the mental simulation of everyday situations identified as painful in participants with non-specific low back pain and healthy volunteers.
The main questions it aims to answer are :
Do participants with low-back pain show reduced variability in center of pressure displacements compared with non-painful participants when faced with mental simulation of everyday situations identified as painful? Is the postural response correlated with the level of kinesiophobia? Participants will be faced to pictures of everyday situations identified as painful while several physiological measurements (posturography, electromyography, heart rate) are being recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-specific chronic low back pain | – | –Participants with non-specific chronic low back pain (>3 months). |
| Control group | – | –Healthy volunteers, without any low back pain. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- General population
Key inclusion criteria (2 listed)
- Age between 18 and 55
- Non-specific chronic low back pain for the concerned group
Key exclusion criteria (4 listed)
- Low back pain for 0 to 3 months
- Unable to stand 1 minute without technical aid
- Neurological, motor or cognitive know impairment
- BMI > 30
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
Standard deviation of the position of the center of pressure on the anteroposterior axis (SD-COP-AP)
Time frame: Baseline
Movements of the center of pressure (COP) are recorded using a force plate, and the SD-COP-AP is calculated after recording and is an indicator of the postural response.
26 secondary outcomes
Mean position of the center of pressure on the anteroposterior axis (COP-AP)
Time frame: Baseline
Mean position of the center of pressure on the mediolateral axis (COP-ML)
Time frame: Baseline
Standard deviation of the position of the center of pressure on the mediolateral axis (SD-COP-ML)
Time frame: Baseline
Sway length of the center of pressure on the anteroposterior axis (L-COP-AP)
Time frame: Baseline
Sway length of the center of pressure on the mediolateral axis (L-COP-ML)
Time frame: Baseline
Tibialis anterior muscle activity
Time frame: Baseline
Soleus muscle activity
Time frame: Baseline
Longissimus dorsi muscle activity
Time frame: Baseline
Co-activation (Soleus/Tibialis anterior)
Time frame: Baseline
Coefficient of variation for muscle activity of tibialis anterior
Time frame: Baseline
Coefficient of variation for muscle activity of soleus
Time frame: Baseline
Coefficient of variation for muscle activity of longissimus dorsi
Time frame: Baseline
Mean heart rate
Time frame: Baseline
Mean RR interval
Time frame: Baseline
Standard deviation of normal RR intervals (SDNN)
Time frame: Baseline
Root mean square of successive R-R intervals (RMSSD)
Time frame: Baseline
Power of very low frequency from frequency analysis (VLF)
Time frame: Baseline
Power of low frequency from frequency analysis (LF)
Time frame: Baseline
Power of high frequency from frequency analysis (HF)
Time frame: Baseline
Ratio of LF/HF (post-frequency analysis)
Time frame: Baseline
Tampa scale for kinesiophobia (TSK) score
Time frame: Baseline
Brief pain inventory (BPI) score
Time frame: Baseline
EQ-5D-5L questionnaire score
Time frame: Baseline
Fear-Avoidance Component Scale (FACS) score
Time frame: Baseline
Pain catastrophizing scale (PCS) score
Time frame: Baseline
Hospital Anxiety and Depression scale (HAD) score
Time frame: Baseline
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 2 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Thierry LELARD, PhD study director
Universite de Picardie Jules Verne
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 Non-specific Chronic Low Back Pain and Healthy Volunteer, run by Universite de Picardie Jules Verne 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 2 inclusion and 4 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 2 Sep 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?
Standard deviation of the position of the center of pressure on the anteroposterior axis (SD-COP-AP) (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 2 Sep 2025.