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NCT Number: NCT07818551

Assessment of Pain Perception and the Impact of Central Sensitization on Biopsychosocial Manifestations During Physical Activity in Patients With Chronic Low Back Pain

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Exercise rehabilitation on an ergocycle

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Pain score

    Time frame: Day 3, before cycle ergometer test initiation

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  2. Pain score

    Time frame: Day 3, 3 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  3. Pain score

    Time frame: Day 3, 6 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  4. Pain score

    Time frame: Day 3, 9 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  5. Pain score

    Time frame: Day 3, 12 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  6. Pain score

    Time frame: Day 3, 15 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  7. Pain score

    Time frame: Day 3, 18 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  8. Pain score

    Time frame: Day 3, 21 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  9. Pain score

    Time frame: Day 3, 24 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  10. Pain score

    Time frame: Day 3, 27 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  11. Pain score

    Time frame: Day 3, 30 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  12. Pain score

    Time frame: Day 5, before cycle ergometer test initiation

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  13. Pain score

    Time frame: Day 5, 3 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  14. Pain score

    Time frame: Day 5, 6 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  15. Pain score

    Time frame: Day 5, 9 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  16. Pain score

    Time frame: Day 5, 12 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  17. Pain score

    Time frame: Day 5, 15 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  18. Pain score

    Time frame: Day 5, 21 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  19. Pain score

    Time frame: Day 5, 24 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  20. Pain score

    Time frame: Day 5, 27 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  21. Pain score

    Time frame: Day 5, 30 minutes after cycle ergometer test initiation, if applicable

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  22. Pain score

    Time frame: Baseline

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

  23. Luomajoki tests score

    Time frame: Baseline

    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.

  24. Tampa Scale of Kinesiophobia

    Time frame: Baseline

    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.

  25. KINAP score

    Time frame: Baseline

    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.

  26. Pain catastrophizing scale

    Time frame: Baseline

    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. Change in pain score

    Time frame: Baseline and Day 40

    Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

François GICQUEL

CONTACT

[email protected]

+33290778080

Mathilde Guillo

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: BASICS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 14, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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