Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain (LIFDI)

Claudio Perret

Status: Enrolling

Conditions: Exercise Therapy; Low Back Pain

Treatments: Other: Personalized back exercises; Other: Non-personalized back exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06938568

2024-01285

63674 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups

Personalized back exercises

Experimental group

Description:

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.

Treatment:

Other: Personalized back exercises

Non-personalized back exercises

Active Comparator group

Description:

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.

Treatment:

Other: Non-personalized back exercises