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L'essai clinique NCT06938568 (LIFDI) pour Thérapie par l'exercice, Douleur lombaire est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain (LIFDI)

En recrutement
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L'étude clinique NCT06938568 (LIFDI) est un essai interventionnel pour Thérapie par l'exercice, Douleur lombaire. Son statut actuel est : en recrutement. L'étude a débuté le 1 mai 2025 et vise à recruter 180 participants. Dirigé par Claudio Perret, l'essai devrait être terminé d'ici le 1 décembre 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 4 mai 2025.
Résumé succinct
Personalized medicine and individualized therapeutic approaches are prominent in current research. But are these approaches also effective for treating non-specific low back pain (NSLBP)? NSLBP is one of the most common musculoskeletal issues, which can impair physical well-being, reduce the quality of life, and limit physical functioning. Additionally, it contributes to substantial direct and indirect healthcare costs, such as frequent doctor visits and work absences. Despite NSLBP being a significant burden for both individuals and society, effective alleviation methods remain unclear. The investigators' research project therefore aims to investigate whether personalized therapy, specifically a personalized physical back training program, can effectively address NSLBP. Within the context of NSLBP, the investigators' specific aim is to improve physical functioning as this outcome is considered relevant from all perspectives, including those of patients, clinical professionals, researchers, and guidelines.
Titre officiel

Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain

Conditions
Thérapie par l'exerciceDouleur lombaire
Autres identifiants de l'essai
  • LIFDI
  • 2024-01285
  • 63674 (Autre financement) (Stiftung Universität Luzern)
Numéro NCT
NCT06938568
Date de début (réel)
2025-05-01
Dernière mise à jour publiée
2025-05-04
Date de fin (estimée)
2027-12
Inscription (estimée)
180
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Physical Functioning
Exercise
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Quadruple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalPersonalized back exercises
The study intervention is a 12-week personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are selected through a clinical reasoning process, i.e., they are tailored and problem-oriented, based on the results of a clinical assessment.
Personalized Back Exercises
The study intervention is a 12-week personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are selected through a clinical reasoning process, i.e., they are tailored and problem-oriented, based on the results of a clinical assessment. An initial one-on-one training session will take place to familiarize participants with the back training program, corresponding to the first week's session of the 12-week intervention period. During the 12-week intervention period, the training comprises one supervised group session per week, lasting 30 minutes, along with three individual unsupervised sessions, each lasting 10-15 minutes. Our procedures ensures that both participants and instructors are blinded to the group allocation, allowing both groups to train together (e.g., mixed training groups).
Comparateur actifNon-personalized back exercises
The active control intervention is a 12-week non-personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are not selected through a clinical reasoning process, i.e., they are neither tailored nor problem-oriented nor based on the results of a clinical assessment.
Non-personalized Back Exercises
The active control intervention is a 12-week non-personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are not selected through a clinical reasoning process, i.e., they are neither tailored nor problem-oriented nor based on the results of a clinical assessment. An initial one-on-one training session will take place to familiarize participants with the back training program, corresponding to the first week's session of the 12-week intervention period. During the 12-week intervention period, the training comprises one supervised group session per week, lasting 30 minutes, along with three individual unsupervised sessions, each lasting 10-15 minutes. Our procedures ensures that both participants and instructors are blinded to the group allocation, allowing both groups to train together (e.g., mixed training groups).
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Self-rated physical functioning
Change in Patient-Specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 100 (able to perform at the same level as before NSLBP)
Baseline to 12 weeks
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Self-rated physical functioning
Change in Patient-Specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 100 (able to perform at the same level as before NSLBP)
Baseline to 4, 8, and 24 weeks
Self-rated physical functioning (RMDQ)
Change in Roland Morris Disability Questionnaire (RMDQ). Range from 0 (no disability) to 24 (maximum disability).
Baseline to 4, 8, 12, and 24 weeks
Health-related quality of life (EQ-VAS)
Change in EQ Visual Analogue Scale (EQ-VAS). Range from 0 (lowest health-related quality of life) to 100 (highest health-related quality of life).
Baseline to 4, 8, 12, and 24 weeks
Health-related quality of life (EQ-5D-5L)
Change in 5-Level EuroQoL5D version (EQ-5D-5L). Range from 0 (lowest health-related quality of life) to 1 (highest health-related quality of life).
Baseline to 4, 8, 12, and 24 weeks
Pain intensity (NRS)
Change in pain intensity (11-point Numeric Rating Scale, NRS). Range from 0 (no pain) to 10 (pain as bad as you can imagine). Recall period: 7 days.
Baseline to 4, 8, 12, and 24 weeks
Safety outcome
Number of serious adverse events (SAE) and adverse events (AE) that are deemed possibly, probably, or definitely related to the intervention (according to our protocol and ClinO, Art. 63, Switzerland).
During the 12 week intervention period
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • Access to the University Sports of the Lucerne Universities (i.e., students, employees, alumni, subscribers)
  • NSLBP for at least 6 weeks
  • Activity limiting NSLBP (at least one activity with a PSFS Score of ≤ 50/100 on a scale from 0 = unable to perform due to NSLBP to 100 = able to perform at the same level as before NSLBP)
  • Age between 18 and 65 years
  • Understand the German language
  • Willing to participate in the study
  • Written informed consent

  • Specific LBP
  • Red flags associated with any serious pathology or specific LBP,
  • Being on a waiting list for or less than 12 months post any surgery of the lower back
  • Pregnancy or given birth within the last 12 months
  • Diagnosed central neurological disease
  • Not allowed to exercise
  • Participant in the feasibility study
  • Expecting to be absent for more than 2 weeks during the intervention period
Claudio Perret logoClaudio Perret
Partie responsable de l'essai
Claudio Perret, Promoteur-Investigateur, Prof. Dr. Claudio Perret, Universität Luzern
Contact central de l'essai
Contact: Claudio Perret, PhD, +41419396650, [email protected]
Contact: Andrea M Aegerter, PhD, +41412295739, [email protected]
1 Centres de l'essai dans 1 pays

Canton of Lucerne

University of Lucerne, Faculty of Health Sciences and Medicine, University Research Centre Health and Society, Lucerne, Canton of Lucerne, 6002, Switzerland
Claudio Perret, PhD, Contact, +41419396650, [email protected]
Andrea M Aegerter, PhD, Contact, +41412295739, [email protected]
Claudio Perret, PhD, Investigateur principal
Andrea M Aegerter, PhD, Investigateur associé
En recrutement