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

ConditionsExercise Therapy Low Back Pain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorClaudio Perret

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Personalized back exercises
Other intervention
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 intervention
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).

Treatment groups

180 Participants

are divided into 2 treatment groups

Group A: Personalized back exercisesExperimental treatment 1 intervention

Group B: Non-personalized back exercisesActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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