The aim of our clinical trial (2024-01285) is to determine how an individualized physical back training program affects physical functioning and back pain. The results will help identify the most effective treatments for low back pain. This feasibility study (2024-01284) aims to conduct a test run of the clinical trial. The main questions are: * Do all procedures run smoothly? * Does the back training program improve physical functioning? * Does the back training program reduce back pain? Participants will: * Follow a back training program for 4 weeks. * Attend group exercise sessions (30 minutes per week) * Perform exercises at home (3x10 minutes per week). * Fill out a daily questionnaire on pain and exercise adherence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
The study intervention is a 4-week personalized physical back training program. The study intervention consists of six 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.
The control intervention is a 4-week non-personalized physical back training program. The control intervention consists of six 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.
University of Lucerne, Faculty of Health Sciences and Medicine, Universitäres Forschungszentrum Gesundheit und Gesellschaft
Lucerne, Canton of Lucerne, Switzerland
Logistical and operational feasibility: Response time
Response time (in days).
Time frame: Baseline
Logistical and operational feasibility: Recruitment capability
Ratio of invited individuals to included participants.
Time frame: Baseline
Logistical and operational feasibility: Sample characteristics
Analyze sample characteristics (e.g., gender, age) using descriptive statistics.
Time frame: Baseline to 4 weeks
Logistical and operational feasibility: Data collection procedures (Access)
Qualitatively evaluate the access of study personnel to necessary documents and the database through interviews.
Time frame: Baseline to 4 weeks
Logistical and operational feasibility: Data collection procedures (Questionnaire)
Qualitatively evaluate the usability of the questionnaire through interviews.
Time frame: Baseline to 4 weeks
Logistical and operational feasibility: Data collection procedures (Clinical Assessment)
Qualitatively evaluate the usability of the clinical assessment through interviews.
Time frame: Baseline to 4 weeks
Logistical and operational feasibility: Acceptability and suitability of the intervention and study procedures
Qualitatively assess the acceptability and suitability of the intervention and study procedures through interviews.
Time frame: Baseline to 4 weeks
Logistical and operational feasibility: Resource management
Qualitatively evaluate the time and personnel required for conducting the study through interviews.
Time frame: Baseline to 4 weeks
Self-rated physical functioning (PSFS)
Change in Patient-specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 10 (able to perform at the same level as before NSLBP).
Time frame: Baseline to 4 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 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 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 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 weeks
Intervention-related (serious) adverse events
Number of serious adverse events (SAE) and adverse events (AE) that are deemed possibly, probably, or definitely related to the intervention (according to ClinO, Art. 63, Switzerland).
Time frame: During the 4 week intervention period
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