An interventional study of Personalized back exercises and Non-personalized back exercises in Exercise Therapy and Low Back Pain, sponsored by Claudio Perret. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by Claudio Perret · Not applicable, Interventional, and Treatment
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.
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's planned enrollment of 180 is above the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
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Exclusion Criteria:
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 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 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).
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).
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)
Time frame: Baseline to 12 weeks
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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: During the 12 week intervention period
Pain frequency
Change in number of episodes with NSLBP. Numerically, with 0 = minimum. Recall period: 7 days.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: At 4, 8, 12, and 24 weeks
Plan to share: Yes — 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.
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.
Access criteria: Access to the data will be granted in accordance with the criteria of the repository and/or publisher.
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