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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: N/A (observational study)

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François GICQUEL; Phone Number: +33290778080; Email: gicquelfrancois@hotmail.fr
• Study Contact Backup: Name: Mathilde Guillo; Email: mathilde.guillo@chu-brest.fr

Study Locations

• France
  • Concarneau, France, 29900
    • SMR pôle Réadaptation de Cornouaille
    • Contact: François GICQUEL; Phone Number: +33290778080; Email: francois.giquel@ugecam.assurance-maladie.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline and Day 40

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain score will be measured using visual analogic scale. Score goes from 0 cm to 10 cm. Higher score is worse outcome.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline and Day 40

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Estimated): September 20, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: September 8, 2026
• First Submitted That Met QC Criteria: September 8, 2026
• First Posted (Actual): September 14, 2026

Study Record Updates

• Last Update Posted (Actual): September 14, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Methods; Observation
• Other Study ID Numbers: 29BRC24.0293 - BASICS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No