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Eine Studie entspricht den Filterkriterien
Kartenansicht
Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain (LIFDI)
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06938568 (LIFDI) ist eine interventionsstudie zur Untersuchung von Übungstherapie, Kreuzschmerzen und hat den Status offene rekrutierung. Die Studie startete am 1. Mai 2025 und soll 180 Teilnehmer aufnehmen. Durchgeführt von Claudio Perret ist der Abschluss für 1. Dezember 2027 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 4. Mai 2025 aktualisiert.
Kurzbeschreibung
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.
Offizieller Titel
Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain
Erkrankungen
ÜbungstherapieKreuzschmerzenWeitere Studien-IDs
- LIFDI
- 2024-01285
- 63674 (Andere Zuwendungs-/Finanzierungsnummer) (Stiftung Universität Luzern)
NCT-Nummer
Studienbeginn (tatsächlich)
2025-05-01
Zuletzt aktualisiert
2025-05-04
Studienende (vorauss.)
2027-12
Geplante Rekrutierung
180
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
Physical Functioning
Exercise
Exercise
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellPersonalized 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). |
Aktives VergleichspräparatNon-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). |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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 PerretVerantwortliche Partei
Claudio Perret, Prüfsponsor, Prof. Dr. Claudio Perret, Universität Luzern
Zentrale Studienkontakte
Kontakt: Claudio Perret, PhD, +41419396650, [email protected]
Kontakt: Andrea M Aegerter, PhD, +41412295739, [email protected]
1 Studienstandorte in 1 Ländern
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, Kontakt, +41419396650, [email protected]
Andrea M Aegerter, PhD, Kontakt, +41412295739, [email protected]
Claudio Perret, PhD, Hauptprüfer
Andrea M Aegerter, PhD, Prüfarzt
Offene Rekrutierung