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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
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).
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).
University of Lucerne, Faculty of Health Sciences and Medicine, University Research Centre Health and Society
Lucerne, Canton of Lucerne, Switzerland
RECRUITINGSelf-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)
Time frame: Baseline to 12 weeks
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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: During the 12 week intervention period
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