Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain: A Feasibility Study
NCT Number: NCT06540911
Acronym: LIFDI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Exercise Therapy|Exercise|Low Back Pain
Interventions: OTHER: Personalized physical back training program|OTHER: Non-personalized physical back training program
Sponsor: Universität Luzern
Collaborators: Luzerner Kantonsspital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2024-12
Locations: University of Lucerne, Faculty of Health Sciences and Medicine, Universitäres Forschungszentrum Gesundheit und Gesellschaft, Luzern, 6002, Switzerland

Summary:
The aim of our clinical trial (2024-01285) is to determine how an individualized physical back training program affects physical functioning and back pain. The results will help identify the most effective treatments for low back pain. This feasibility study (2024-01284) aims to conduct a test run of the clinical trial. The main questions are:

* Do all procedures run smoothly?
* Does the back training program improve physical functioning?
* Does the back training program reduce back pain?

Participants will:

* Follow a back training program for 4 weeks.
* Attend group exercise sessions (30 minutes per week)
* Perform exercises at home (3x10 minutes per week).
* Fill out a daily questionnaire on pain and exercise adherence.

Primary Outcome Measures: Logistical and operational feasibility: Response time, Response time (in days)., Baseline|Logistical and operational feasibility: Recruitment capability, Ratio of invited individuals to included participants., Baseline|Logistical and operational feasibility: Sample characteristics, Analyze sample characteristics (e.g., gender, age) using descriptive statistics., Baseline to 4 weeks|Logistical and operational feasibility: Data collection procedures (Access), Qualitatively evaluate the access of study personnel to necessary documents and the database through interviews., Baseline to 4 weeks|Logistical and operational feasibility: Data collection procedures (Questionnaire), Qualitatively evaluate the usability of the questionnaire through interviews., Baseline to 4 weeks|Logistical and operational feasibility: Data collection procedures (Clinical Assessment), Qualitatively evaluate the usability of the clinical assessment through interviews., Baseline to 4 weeks|Logistical and operational feasibility: Acceptability and suitability of the intervention and study procedures, Qualitatively assess the acceptability and suitability of the intervention and study procedures through interviews., Baseline to 4 weeks|Logistical and operational feasibility: Resource management, Qualitatively evaluate the time and personnel required for conducting the study through interviews., Baseline to 4 weeks
Secondary Outcome Measures: Self-rated physical functioning (PSFS), Change in Patient-specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 10 (able to perform at the same level as before NSLBP)., Baseline to 4 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 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 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 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 weeks|Intervention-related (serious) adverse events, Number of serious adverse events (SAE) and adverse events (AE) that are deemed possibly, probably, or definitely related to the intervention (according to ClinO, Art. 63, Switzerland)., During the 4 week intervention period
Other Outcome Measures: Pain frequency, Change in number of episodes with NSLBP. Numerically, with 0 = minimum. Recall period: 7 days., Baseline to 4 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 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 weeks|Pain extent, Change in pain extent. Percentages of the body with NSLBP, with 0%=minimum, Baseline to 4 weeks|Performance-based physical functioning (pressure pain threshold), Change in pressure pain threshold. kPA, with 0=minimum, Baseline to 4 weeks|Performance-based physical functioning (range of motion), Change in range of motion. Degrees, with 0=minimum, Baseline to 4 weeks|Performance-based physical functioning (strength), Change in strength. Nm, with 0=minimum, Baseline to 4 weeks|Performance-based physical functioning (neurodynamics), Change in neurodynamics. Positive, negative., Baseline to 4 weeks|Performance-based physical functioning (movement control), Change in movement control. Positive, negative., Baseline to 4 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 weeks|Participant satisfaction, Change in 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). 5-point Likert scale (strongly agree, agree, uncertain, disagree, strongly disagree)., Baseline to 4 weeks