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

NCT07818551 | Not Yet Recruiting

• 1 other identifier: 29BRC24.0293 - BASICS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (27)

• Pain score

  Day 3, before cycle ergometer test initiation

• Pain score

  Day 3, 3 minutes after cycle ergometer test initiation, if applicable

• Pain score

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

• Pain score

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

• Pain score

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

Study Arms (1)

Exercise rehabilitation on an ergocycle

OTHER

Exercise rehabilitation on an ergocycle

Other: Exercise rehabilitation on an ergocycle

Interventions

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.

Exercise rehabilitation on an ergocycle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

SMR pôle Réadaptation de Cornouaille

Concarneau, 29900, France

Location

Central Study Contacts

François GICQUEL

CONTACT

+33290778080; gicquelfrancois@hotmail.fr

Mathilde Guillo

CONTACT

mathilde.guillo@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

FR (1)