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

• Personalized back exercises (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 (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).

Primary outcomes

• Self-rated physical functioning [Baseline to 12 weeks]: 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)

Secondary outcomes

• Self-rated physical functioning [Baseline to 4, 8, and 24 weeks]: 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)
• Self-rated physical functioning (RMDQ) [Baseline to 4, 8, 12, and 24 weeks]: Change in Roland Morris Disability Questionnaire (RMDQ). Range from 0 (no disability) to 24 (maximum disability).
• Health-related quality of life (EQ-VAS) [Baseline to 4, 8, 12, and 24 weeks]: 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).
• Health-related quality of life (EQ-5D-5L) [Baseline to 4, 8, 12, and 24 weeks]: 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).
• Pain intensity (NRS) [Baseline to 4, 8, 12, and 24 weeks]: 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.
• Safety outcome [During the 12 week intervention period]: 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).

Other outcomes

• Pain frequency [Baseline to 4, 8, 12, and 24 weeks]: Change in number of episodes with NSLBP. Numerically, with 0 = minimum. Recall period: 7 days.
• Pain duration [Baseline to 4, 8, 12, and 24 weeks]: 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.
• Pain interference (PEG) [Baseline to 4, 8, 12, and 24 weeks]: 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.
• NSLBP-related work productivity loss [Baseline to 4, 8, 12, and 24 weeks]: Change in Work Productivity and Activity Impairment Questionnaire (WPAI). Percentages, with 0%=no work productivity loss.
• Participant satisfaction [At 4, 8, 12, and 24 weeks]: 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).

Sex: All, ages: 18 Years to 65 Years

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

• Claudio Perret, PhD, Principal investigator, University of Lucerne, University Research Centre Health and Society