An interventional study of Exercise rehabilitation on an ergocycle in Chronic Low Back Pain, sponsored by University Hospital, Brest. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by University Hospital, Brest · Not applicable, Interventional, and Other
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:
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Exercise rehabilitation on an ergocycle
Other: Exercise rehabilitation on an ergocycle
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Day 40
Pain score
Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Day 40
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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