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

15 settembre 2026 aggiornato da: University Hospital, Brest

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Luomajoki tests score
Lasso di tempo: 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.
Baseline and Day 40
Change in Tampa Scale of Kinesiophobia
Lasso di tempo: 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.
Baseline and Day 40
Change in KINAP score
Lasso di tempo: 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.
Baseline and Day 40
Change in Pain catastrophizing scale
Lasso di tempo: 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.
Baseline and Day 40

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain score
Lasso di tempo: 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.
Day 3, before cycle ergometer test initiation
Pain score
Lasso di tempo: 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.
Day 3, 3 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 3, 6 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 3, 9 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 3, 12 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 3, 15 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 3, 18 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 3, 21 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 3, 24 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 3, 27 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 3, 30 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 5, before cycle ergometer test initiation
Pain score
Lasso di tempo: 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.
Day 5, 3 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 5, 6 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 5, 9 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 5, 12 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 5, 15 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 5, 21 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 5, 24 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 5, 27 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: 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.
Day 5, 30 minutes after cycle ergometer test initiation, if applicable
Pain score
Lasso di tempo: Baseline
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
Lasso di tempo: 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.
Baseline
Tampa Scale of Kinesiophobia
Lasso di tempo: 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.
Baseline
KINAP score
Lasso di tempo: 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.
Baseline
Pain catastrophizing scale
Lasso di tempo: 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.
Baseline
Change in pain score
Lasso di tempo: 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.
Baseline and Day 40

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

20 settembre 2026

Completamento primario (Stimato)

30 aprile 2028

Completamento dello studio (Stimato)

30 aprile 2028

Date di iscrizione allo studio

Primo inviato

8 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 settembre 2026

Primo Inserito (Effettivo)

14 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 29BRC24.0293 - BASICS

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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