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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Exercise Therapy
• Intervention / Treatment: Other: Personalized back exercises; Other: Non-personalized back exercises

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudio Perret, PhD; Phone Number: +41419396650; Email: claudio.perret@unilu.ch
• Study Contact Backup: Name: Andrea M Aegerter, PhD; Phone Number: +41412295739; Email: andrea.aegerter@unilu.ch

Study Locations

• Switzerland
  • Lucerne, Switzerland, 6002
    • Recruiting
    • University of Lucerne, Faculty of Health Sciences and Medicine, University Research Centre Health and Society
    • Contact: Claudio Perret, PhD; Phone Number: +41419396650; Email: claudio.perret@unilu.ch
    • Contact: Andrea M Aegerter, PhD; Phone Number: +41412295739; Email: andrea.aegerter@unilu.ch
    • Principal Investigator: Claudio Perret, PhD
    • Sub-Investigator: Andrea M Aegerter, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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'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).
Active Comparator: 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-rated physical functioning	Change in Patient-Specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 100 (able to perform at the same level as before NSLBP)	Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-rated physical functioning	Change in Patient-Specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 100 (able to perform at the same level as before NSLBP)	Baseline to 4, 8, and 24 weeks
Self-rated physical functioning (RMDQ)	Change in Roland Morris Disability Questionnaire (RMDQ). Range from 0 (no disability) to 24 (maximum disability).	Baseline to 4, 8, 12, and 24 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).	Baseline to 4, 8, 12, and 24 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).	Baseline to 4, 8, 12, and 24 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.	Baseline to 4, 8, 12, and 24 weeks
Safety outcome	Number of serious adverse events (SAE) and adverse events (AE) that are deemed possibly, probably, or definitely related to the intervention (according to our protocol and ClinO, Art. 63, Switzerland).	During the 12 week intervention period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain frequency	Change in number of episodes with NSLBP. Numerically, with 0 = minimum. Recall period: 7 days.	Baseline to 4, 8, 12, and 24 weeks
Pain duration	Change in pain duration (e.g., average duration of an episode of NSLBP within the last 7 days). In minutes, hours, or days, with 0 = minimum. Recall period: 7 days.	Baseline to 4, 8, 12, and 24 weeks
Pain interference (PEG)	Change in Pain, Enjoyment, and General Activity (PEG) 3-Item Scale. Range from 0 (no pain; does not interfere) to 10 (pain as bad as you can imagine; completely interferes). Recall period: 7 days.	Baseline to 4, 8, 12, and 24 weeks
NSLBP-related work productivity loss	Change in Work Productivity and Activity Impairment Questionnaire (WPAI). Percentages, with 0%=no work productivity loss.	Baseline to 4, 8, 12, and 24 weeks
Participant satisfaction	Participant satisfaction (e.g., 1. I am satisfied with the training program I received. 2. I am satisfied with the result of the training program). 4-point Likert scale (strongly agree, agree, disagree, strongly disagree).	At 4, 8, 12, and 24 weeks

Collaborators and Investigators

• Sponsor: Claudio Perret
• Investigators: Principal Investigator: Claudio Perret, PhD, University of Lucerne, University Research Centre Health and Society

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Physical Functioning
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2024-01285; 63674 (Other Grant/Funding Number: Stiftung Universität Luzern)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is anticipated that the investigators will make encrypted individual participant data (IPD) available via a data repository and, additionally, upon reasonable request to the Principal Investigator. In both cases, only data from participants who have provided informed consent for data sharing will be made available.
• IPD Sharing Time Frame: It is anticipated that the data will be made available as soon as possible after the completion of the study and will remain accessible for at least 10 years.
• IPD Sharing Access Criteria: Access to the data will be granted in accordance with the criteria of the repository and/or publisher.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No