Chronic Low Back PainBASICSNCT07818551
Assessment of Pain Perception and the Impact of Central Sensitization on Biopsychosocial Manifestations During Physical Activity in Patients With Chronic Low Back Pain
A study testing Exercise rehabilitation on an ergocycle in people with Chronic Low Back Pain, run by University Hospital, Brest at 1 site in France.
Trial summary
The goal of this prospective observational study is to evaluate changes in cognitive and behavioural markers associated with central sensitisation between the start and end of an exercise retraining programme on an exercise bike, in adult patients suffering from chronic lower back pain associated with an untreated… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Exercise rehabilitation on an ergocycle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2026to 30 Apr 2028
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, ages 18 through 75 inclusive, admitted to the Musculoskeletal Rehabilitation Unit at the Concarneau Regional Hospital
- Chronic low back pain due to degenerative spine disease that has not been treated surgically, with or without referred pain
- Low back pain intensity of 4/10 or less on the EVA scale
- Pain lasting more than 12 months (= critical period for cerebral impairment)
- Oswestry score between 21% and 40%
- CSI score of 33/100 or higher for women and 25/100 or higher for men
- Patients enrolled in or covered by a social security program
- Patients who have signed a consent form
Who cannot join
- Patients with acute low back pain of traumatic or neoplastic origin
- Patients with a contraindication to moderate-intensity physical activity (Borg 4-5/10 on the modified Borg scale)
- Inability to participate in sessions due to pain unrelated to low back pain or a disability
- Pregnant or breastfeeding patients
- Patients under legal guardianship or conservatorship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mathilde Guillo contact
France1 site
SMR pôle Réadaptation de Cornouaille
Concarneau, 29900
François GICQUEL, +33290778080, francois.giquel@ugecam.assurance-maladie.fr
About this study
The goal of this prospective observational study is to evaluate changes in cognitive and behavioural markers associated with central sensitisation between the start and end of an exercise retraining programme on an exercise bike, in adult patients suffering from chronic lower back pain associated with an untreated degenerative spine, worth or without referred pain.
The main changes it will evaluate are:
Read more
- Changes in cognitive and behavioural markers associated with central sensitisation between Day 0 and Day 40 during exercise retraining on an exercise bike as part of a rehabilitation programme for chronic low back pain
Participants will undergo the followings:
- A calibration test used to define moderate exertion on an ergocycle, corresponding to a perceived exertion of 4-5/10 on the modified Borg scale
- Exercise-induced pain intensity assessment tests to detect changes in the intensity of pain during physical activity and the activity's potential to cause pain, realised on ergocyle
- Exercise rehabilitation on an ergocycle
- Final tests to assess cognitive and behavioural markers related to central sensitisation and pain intensity, as at baseline.
Read the detailed description
Patients with chronic low back pain who are scheduled to receive care at the Musculoskeletal Rehabilitation Unit of the Cornouaille Rehabilitation Center in Concarneau for low back pain rehabilitation-either through a group program on a part-time inpatient basis or an individual program on a full-time inpatient basis-will be considered for inclusion in the study.
Eligible patients will be enrolled after the investigator has provided them with comprehensive verbal and written information, conducted initial assessments, verified the inclusion and exclusion criteria, and obtained signed informed consent from the patients. For inpatients, verification of inclusion and exclusion criteria will take place on the day of admission to the Concarneau PRC during the initial evaluation.
Upon admission, the patient is assessed according to standard criteria for the management of patients with low back pain (measurements of spinal mobility: Fingers-to-Floor Distance (FFD), spinal inclinometry in flexion and extension, lateral bending, Schober's test, muscle strength assessment: Shirado and Sorensen tests, measurement of hamstring and quadriceps hyperextensibility), to which are added the Oswestry Questionnaire to assess disability related to low back pain, the CSI questionnaire, which assesses symptoms of central sensitization, and an evaluation of various cognitive-behavioral markers related to central sensitization, including sensitization due to motor disorders (Luomajoki tests), sensitization due to kinesiophobia (Tempa Scale of Kinesiophobia and KINAP), and sensitization due to catastrophizing (Pain Catastrophizing Scale).
After enrollment, patients will undergo a calibration test on an exercise bike on Day 1 to determine the power required to maintain a constant moderate effort corresponding to an intensity of 4-5/10 on the modified Borg scale. Then, to assess the pain-inducing potential of exercise on an ergocycle, they will perform two tests (on Day 3 and Day 5) to evaluate changes in pain during moderate, sustained exercise.
During their rehabilitation for low back pain, patients undergo exercise retraining on an ergocycle. From Day 8 through Day 40 (3 times per week, on Mondays, Wednesdays, and Fridays), the patients' perceived exertion will be assessed at the end of each ergometer session to verify that they are indeed maintaining a constant moderate level of exertion.
Patients will be assessed on Day 40 to collect measurements of cognitive-behavioral markers related to central sensitization and pain intensity, as was done at enrollment.
- Conditions
- Chronic Low Back Pain
- Being tested
- Exercise rehabilitation on an ergocycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise rehabilitation on an ergocycleOther
Following enrolment, patients will undergo a calibration test on an ergocycle on Day 1 to determine the power required to maintain a constant moderate effort corresponding to an intensity of 4-5/10 on the modified Borg scale. Then, to assess the pain-inducing potential of exercise on the ergocycle, they will undertake two tests (on Day 3 and Day 5) to evaluate changes in pain during constant moderate exertion.
During their rehabilitation programme for low back pain, patients will undergo exercise retraining on the ergocycle. From Day 8 to Day 40 (three times a week, on Mondays, Wednesdays and Fridays), the patients' perception of exertion will be assessed at the end of each exercise bike session to ensure that they are maintaining a constant moderate level of exertion.
Patients will be assessed on Day 40 to collect data on cognitive and behavioural markers related to central sensitisation and pain intensity, as at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Exercise rehabilitation on an ergocycle | Other | Exercise rehabilitation on an ergocycle Receives: Other: Exercise rehabilitation on an ergocycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Luomajoki tests score
The Luomajoki test consists of six movement control tests assessing lumbar movement control. The score is calculated as the number of positive tests and ranges from 0 to 6. Higher score is worse outcome.
Measured: Baseline and Day 40
Change in Tampa Scale of Kinesiophobia
The Tampa Scale of Kinesiophobia is a questionnaire used to assess kinesiophobia, defined as the fear of movement. It consists of 17 items, each rated on a 4-point scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). The score is calculated as the sum of the 17 items and ranges from 17 to 68. Higher score is worse outcome.
Measured: Baseline and Day 40
Change in KINAP score
The KINAP consists of presenting participants with photographs illustrating physical and sports activities. For each photograph, participants are asked to rate, on a scale from 0% to 100%, the intensity of their fear regarding potential negative consequences (e.g., pain). The total score is calculated as the mean of the ratings provided for all photographs and ranges from 0% to 100%. Higher scores indicate greater fear and represent a worse outcome.
Measured: Baseline and Day 40
Change in Pain catastrophizing scale
The Pain Catastrophizing Scale is used to assess the tendency to exaggerate the threat of pain, ruminate about pain, and experience feelings of helplessness in relation to pain. It consists of 13 items, each rated from 0 ("not at all") to 4 ("all the time"). The total score is calculated as the sum of the scores of the 13 items and ranges from 0 to 52 Higher score is worse outcome.
Measured: Baseline and Day 40
Secondary outcomes (27)
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 3, before cycle ergometer test initiation
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 3, 3 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 3, 6 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 3, 9 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 3, 12 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 3, 15 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 3, 18 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 3, 21 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 3, 24 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 3, 27 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 3, 30 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 5, before cycle ergometer test initiation
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 5, 3 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 5, 6 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 5, 9 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 5, 12 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 5, 15 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 5, 21 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 5, 24 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 5, 27 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Day 5, 30 minutes after cycle ergometer test initiation, if applicable
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Baseline
Luomajoki tests score
The Luomajoki test consists of six movement control tests assessing lumbar movement control. The score is calculated as the number of positive tests and ranges from 0 to 6. Higher score is worse outcome.
Measured: Baseline
Tampa Scale of Kinesiophobia
The Tampa Scale of Kinesiophobia is a questionnaire used to assess kinesiophobia, defined as the fear of movement. It consists of 17 items, each rated on a 4-point scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). The score is calculated as the sum of the 17 items and ranges from 17 to 68. Higher score is worse outcome.
Measured: Baseline
KINAP score
The KINAP consists of presenting participants with photographs illustrating physical and sports activities. For each photograph, participants are asked to rate, on a scale from 0% to 100%, the intensity of their fear regarding potential negative consequences (e.g., pain). The total score is calculated as the mean of the ratings provided for all photographs and ranges from 0% to 100%. Higher scores indicate greater fear and represent a worse outcome.
Measured: Baseline
Pain catastrophizing scale
The Pain Catastrophizing Scale is used to assess the tendency to exaggerate the threat of pain, ruminate about pain, and experience feelings of helplessness in relation to pain. It consists of 13 items, each rated from 0 ("not at all") to 4 ("all the time"). The total score is calculated as the sum of the scores of the 13 items and ranges from 0 to 52 Higher score is worse outcome.
Measured: Baseline
Change in pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Measured: Baseline and Day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (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, BrestThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818551
- Sponsor's protocol ID
- 29BRC24.0293 - BASICS
- Acronym
- BASICS
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 18 Sep 2026
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pain Perception and the Impact of Central Sensitization on Biopsychosocial Manifestations During Physical Activity in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07818551
- Acronym / sponsor ID
- BASICS / 29BRC24.0293 - BASICS
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 14 Sep 2026 (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 prospective observational study is to evaluate changes in cognitive and behavioural markers associated with central sensitisation between the start and end of an exercise retraining programme on an exercise bike, in adult patients suffering from chronic lower back pain associated with an untreated degenerative spine, worth or without referred pain.
The main changes it will evaluate are:
- Changes in cognitive and behavioural markers associated with central sensitisation between Day 0 and Day 40 during exercise retraining on an exercise bike as part of a rehabilitation programme for chronic low back pain
Participants will undergo the followings:
- A calibration test used to define moderate exertion on an ergocycle, corresponding to a perceived exertion of 4-5/10 on the modified Borg scale
- Exercise-induced pain intensity assessment tests to detect changes in the intensity of pain during physical activity and the activity's potential to cause pain, realised on ergocyle
- Exercise rehabilitation on an ergocycle
- Final tests to assess cognitive and behavioural markers related to central sensitisation and pain intensity, as at baseline.
Detailed description
Patients with chronic low back pain who are scheduled to receive care at the Musculoskeletal Rehabilitation Unit of the Cornouaille Rehabilitation Center in Concarneau for low back pain rehabilitation-either through a group program on a part-time inpatient basis or an individual program on a full-time inpatient basis-will be considered for inclusion in the study.
Eligible patients will be enrolled after the investigator has provided them with comprehensive verbal and written information, conducted initial assessments, verified the inclusion and exclusion criteria, and obtained signed informed consent from the patients. For inpatients, verification of inclusion and exclusion criteria will take place on the day of admission to the Concarneau PRC during the initial evaluation.
Upon admission, the patient is assessed according to standard criteria for the management of patients with low back pain (measurements of spinal mobility: Fingers-to-Floor Distance (FFD), spinal inclinometry in flexion and extension, lateral bending, Schober's test, muscle strength assessment: Shirado and Sorensen tests, measurement of hamstring and quadriceps hyperextensibility), to which are added the Oswestry Questionnaire to assess disability related to low back pain, the CSI questionnaire, which assesses symptoms of central sensitization, and an evaluation of various cognitive-behavioral markers related to central sensitization, including sensitization due to motor disorders (Luomajoki tests), sensitization due to kinesiophobia (Tempa Scale of Kinesiophobia and KINAP), and sensitization due to catastrophizing (Pain Catastrophizing Scale).
After enrollment, patients will undergo a calibration test on an exercise bike on Day 1 to determine the power required to maintain a constant moderate effort corresponding to an intensity of 4-5/10 on the modified Borg scale. Then, to assess the pain-inducing potential of exercise on an ergocycle, they will perform two tests (on Day 3 and Day 5) to evaluate changes in pain during moderate, sustained exercise.
During their rehabilitation for low back pain, patients undergo exercise retraining on an ergocycle. From Day 8 through Day 40 (3 times per week, on Mondays, Wednesdays, and Fridays), the patients' perceived exertion will be assessed at the end of each ergometer session to verify that they are indeed maintaining a constant moderate level of exertion.
Patients will be assessed on Day 40 to collect measurements of cognitive-behavioral markers related to central sensitization and pain intensity, as was done at enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise rehabilitation on an ergocycle | Other | Other: Exercise rehabilitation on an ergocycleExercise rehabilitation on an ergocycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients, ages 18 through 75 inclusive, admitted to the Musculoskeletal Rehabilitation Unit at the Concarneau Regional Hospital
- Chronic low back pain due to degenerative spine disease that has not been treated surgically, with or without referred pain
- Low back pain intensity of 4/10 or less on the EVA scale
- Pain lasting more than 12 months (= critical period for cerebral impairment)
- Oswestry score between 21% and 40%
Key exclusion criteria (5 listed)
- Patients with acute low back pain of traumatic or neoplastic origin
- Patients with a contraindication to moderate-intensity physical activity (Borg 4-5/10 on the modified Borg scale)
- Inability to participate in sessions due to pain unrelated to low back pain or a disability
- Pregnant or breastfeeding patients
- Patients under legal guardianship or conservatorship
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 |
|---|---|---|
| Exercise rehabilitation on an ergocycleFollowing enrolment, patients will undergo a calibration test on an ergocycle on Day 1 to determine the power required to maintain a constant moderate effort corresponding to an intensity of 4-5/10 on the modified Borg scale. Then, to assess the pain-inducing potential of exercise on the ergocycle, they will undertake two tests (on Day 3 and Day 5) to evaluate changes in pain during constant moderate exertion. During their rehabilitation programme for low back pain, patients will undergo exercise retraining on the ergocycle. From Day 8 to Day 40 (three times a week, on Mondays, Wednesdays and Fridays), the patients' perception of exertion will be assessed at the end of each exercise bike session to ensure that they are maintaining a constant moderate level of exertion. Patients will be assessed on Day 40 to collect data on cognitive and behavioural markers related to central sensitisation and pain intensity, as at baseline. | Other | Exercise rehabilitation on an ergocycle |
Primary outcome
Change in Luomajoki tests score
Time frame: Baseline and Day 40
The Luomajoki test consists of six movement control tests assessing lumbar movement control. The score is calculated as the number of positive tests and ranges from 0 to 6. Higher score is worse outcome.
Change in Tampa Scale of Kinesiophobia
Time frame: Baseline and Day 40
The Tampa Scale of Kinesiophobia is a questionnaire used to assess kinesiophobia, defined as the fear of movement. It consists of 17 items, each rated on a 4-point scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). The score is calculated as the sum of the 17 items and ranges from 17 to 68. Higher score is worse outcome.
Change in KINAP score
Time frame: Baseline and Day 40
The KINAP consists of presenting participants with photographs illustrating physical and sports activities. For each photograph, participants are asked to rate, on a scale from 0% to 100%, the intensity of their fear regarding potential negative consequences (e.g., pain). The total score is calculated as the mean of the ratings provided for all photographs and ranges from 0% to 100%. Higher scores indicate greater fear and represent a worse outcome.
Change in Pain catastrophizing scale
Time frame: Baseline and Day 40
The Pain Catastrophizing Scale is used to assess the tendency to exaggerate the threat of pain, ruminate about pain, and experience feelings of helplessness in relation to pain. It consists of 13 items, each rated from 0 ("not at all") to 4 ("all the time"). The total score is calculated as the sum of the scores of the 13 items and ranges from 0 to 52 Higher score is worse outcome.
27 secondary outcomes
Pain score
Time frame: Day 3, before cycle ergometer test initiation
Pain score
Time frame: Day 3, 3 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 3, 6 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 3, 9 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 3, 12 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 3, 15 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 3, 18 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 3, 21 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 3, 24 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 3, 27 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 3, 30 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 5, before cycle ergometer test initiation
Pain score
Time frame: Day 5, 3 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 5, 6 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 5, 9 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 5, 12 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 5, 15 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 5, 21 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 5, 24 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 5, 27 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Day 5, 30 minutes after cycle ergometer test initiation, if applicable
Pain score
Time frame: Baseline
Luomajoki tests score
Time frame: Baseline
Tampa Scale of Kinesiophobia
Time frame: Baseline
KINAP score
Time frame: Baseline
Pain catastrophizing scale
Time frame: Baseline
Change in pain score
Time frame: Baseline and Day 40
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 18 Sep 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.
Mathilde Guillo contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise rehabilitation on an ergocycle in people with Chronic Low Back Pain, run by University Hospital, Brest 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 8 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: opening soon, as of the sponsor's last update on 18 Sep 2026. 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 François GICQUEL (+33290778080, gicquelfrancois@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Luomajoki tests score (time frame: Baseline and Day 40). 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?
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 18 Sep 2026.