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

NCT ID: NCT06938568

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-12-31

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.

Conditions

Exercise Therapy; Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Personalized back exercises

Intervention Type: OTHER

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).

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.

Group Type: ACTIVE_COMPARATOR

Non-personalized back exercises

Intervention Type: OTHER

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).

Interventions

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'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).

Intervention Type: 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, 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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Claudio Perret

OTHER

Sponsor Role: lead

Responsible Party

Claudio Perret

Prof. Dr. Claudio Perret

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Claudio Perret, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Lucerne, University Research Centre Health and Society

Locations

University of Lucerne, Faculty of Health Sciences and Medicine, University Research Centre Health and Society

Lucerne, Canton of Lucerne, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Claudio Perret, PhD

Role: CONTACT

claudio.perret@unilu.ch

+41419396650

Andrea M Aegerter, PhD

Role: CONTACT

andrea.aegerter@unilu.ch

+41412295739

Facility Contacts

Claudio Perret, PhD

Role: primary

claudio.perret@unilu.ch

+41419396650

Andrea M Aegerter, PhD

Role: backup

andrea.aegerter@unilu.ch

+41412295739

Other Identifiers

63674

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-01285

Identifier Type: -

Identifier Source: org_study_id