Clinical trial NCT06938568: Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain
Official title: Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise Therapy
Low Back Pain
Keywords: Physical Functioning
Exercise
Lead sponsor: Universität Luzern
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Self-rated physical functioning
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Self-rated physical functioning
timeFrame: Baseline to 4, 8, and 24 weeks
measure: Self-rated physical functioning (RMDQ)
timeFrame: Baseline to 4, 8, 12, and 24 weeks
measure: Health-related quality of life (EQ-VAS)
timeFrame: Baseline to 4, 8, 12, and 24 weeks
measure: Health-related quality of life (EQ-5D-5L)
timeFrame: Baseline to 4, 8, 12, and 24 weeks
measure: Pain intensity (NRS)
timeFrame: Baseline to 4, 8, 12, and 24 weeks
measure: Safety outcome
timeFrame: During the 12 week intervention period
Other outcomes:
measure: Pain frequency
timeFrame: Baseline to 4, 8, 12, and 24 weeks
measure: Pain duration
timeFrame: Baseline to 4, 8, 12, and 24 weeks
measure: Pain interference (PEG)
timeFrame: Baseline to 4, 8, 12, and 24 weeks
measure: NSLBP-related work productivity loss
timeFrame: Baseline to 4, 8, 12, and 24 weeks
measure: Participant satisfaction
timeFrame: At 4, 8, 12, and 24 weeks
Locations:
city: Lucerne
country: Switzerland
facility: University of Lucerne, Faculty of Health Sciences and Medicine, University Research Centre Health and Society
Study officials:
affiliation: University of Lucerne, University Research Centre Health and Society
name: Claudio Perret, PhD
role: PRINCIPAL_INVESTIGATOR
References: