M54.5
Conditions
Interventions
Group 1: Participants allocated to the control group attend physician-prescribed orthopaedic rehabilitation exercise once per week for a period of 12 weeks in a group setting. A total of 12 sessions i
Sponsors
Bergische Universität Wuppertal, Lehrstuhl für Sportmedizin
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Physician-prescribed orthopaedic rehabilitation exercise - Chronic non-specific low back pain - Pain located above the lumbosacral junction and below the costal margin - Ability to understand the study information and provide written informed consent independently
Exclusion criteria
Exclusion criteria: - Inability to provide informed consent - Diagnosed tumours - Fractures and/or osteoporosis - Infectious or rheumatic diseases of the spine - Acute or serious comorbidities that may compromise safe participation in the exercise programme or study assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective pain intensity: Change in self-reported low back pain intensity from baseline before the intervention (T0) to the end of the 12-week intervention (T1) and at follow-up (T2). Pain intensity is assessed using an 11-point numerical rating scale ranging from 0 to 10. Higher scores indicate greater subjective pain intensity. Pain sensitivity: Change in pressure pain threshold at the lumbar region from baseline (T0) to the end of the 12-week intervention (T1) and at follow-up (T2). Pressure pain threshold is assessed by pressure algometry at predefined lumbar and distal measurement sites. Two measurements are performed at each site and averaged. Pressure application is stopped as soon as the pressure sensation is first perceived as painful. Results are reported in newtons. | — |
Secondary
| Measure | Time frame |
|---|---|
| Trunk strength: Change in maximal isometric trunk-flexion and trunk-extension strength from baseline (T0) to the end of the 12-week intervention (T1). Strength is assessed using the E.M.L.A. system (Electronic Muscle Performance Assessment). Following a general and task-specific warm-up, three maximal trials are performed for each movement direction. The highest value obtained is recorded. Trunk-flexion and trunk-extension strength are analysed as separate outcome variables. Low back pain-related functional disability: Change in functional disability from baseline (T0) to the end of the intervention (T1) and follow-up (T2). Functional disability is assessed using the Oswestry Disability Index (ODI) and the Roland-Morris Disability Questionnaire (RMDQ). Higher scores indicate greater functional disability. Health-related quality of life: Change in health-related quality of life from baseline (T0) to the end of the intervention (T1) and follow-up (T2). Health-related quality of life is assessed using the 12-Item Short Form Health Survey (SF-12). Higher scores indicate better health-related quality of life. Physical activity outside the study intervention: Physical activity outside the study intervention is assessed during the 12-week intervention using a modified version of the International Physical Activity Questionnaire (IPAQ). These data are used to describe and control for physical activity performed outside the prescribed study interventions. Acute change in pain intensity following exercise: Current low back pain intensity is assessed immediately before and after each supervised exercise session using an 11-point numerical rating scale ranging from 0 to 10. The outcome is the change in pain intensity from before to after each exercise session. Higher scores indicate greater pain intensity. No pre-post assessment is conducted for the home-based exercise sessions. | — |
Countries
Germany
Contacts
Public ContactFabian Tomschi
Bergische Universität Wuppertal, Lehrstuhl für Sportmedizin
Outcome results
None listed