Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized back exercises, Non-personalized back exercises.
- Who it may be relevant to
- Registry conditions: Exercise Therapy, Low Back Pain. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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 - Other 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, cor
Primary outcome measures
- Self-rated physical functioning [Time frame: Baseline to 12 weeks]
Secondary outcome measures (6)
- Self-rated physical functioning [Time frame: Baseline to 4, 8, and 24 weeks]
- Self-rated physical functioning (RMDQ) [Time frame: Baseline to 4, 8, 12, and 24 weeks]
- Health-related quality of life (EQ-VAS) [Time frame: Baseline to 4, 8, 12, and 24 weeks]
- Health-related quality of life (EQ-5D-5L) [Time frame: Baseline to 4, 8, 12, and 24 weeks]
- Pain intensity (NRS) [Time frame: Baseline to 4, 8, 12, and 24 weeks]
- Safety outcome [Time frame: During the 12 week intervention period]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- University of Lucerne, Faculty of Health Sciences and Medicine, University Research Centre — Lucerne
Identifiers
NCT: NCT06938568 · 2024-01285 · 63674