Analysis of the effectiveness of radial shock wave therapy as part of a multimodal pain therapy in the inpatient setting. Different therapy protocols are compared in previously non-operated and in previously operated patients.
Radial shock wave therapy is an approved pain therapy procedure that has been used in various degenerative orthopedic diseases for years. There are a few studies on the subject of chronic back pain. Some studies suggest that this method can be used sensibly. A direct comparison of different therapy protocols has not been carried out so far. As part of inpatient multimodal pain therapy (including infiltration and physiotherapy) in patients with chronic lumbar back pain with or without degenerative surgery in the area of the lumbar spine radial shock wave therapy after a specific protocol is used. Only inpatients will be admitted to the study. All patients are informed verbally and give their written consent. Comprehensive patient information will be provided before the start of the study, handed out and explained as part of the information discussion. There will be 2 groups ((a) patients with previous degenerative surgery in the area of the lumbar spine, (b) patients without such a pre-operation) examined each with 4 sub-groups depending of the different therapy protocols.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz
application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz
standard multimodal pain therapy
Klinik Blankenstein
Hattingen, Germany
change in Numeric Rating Scale (NRS)
Pain intensity measured by Numeric Rating Scale (NRS) \- 11-point scale / min. 0 (better outcome) / max. 10 (worse outcome)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in European Quality of Life 5 Dimensions (EQ5D)
European Quality of Life 5 Dimensions (EQ5D)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Pain Self-Efficacy Questionnaire (PSEQ)
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Patient Health Questionnaire-9 (PHQ-9)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Perseverative Thinking Questionnaire (PTQ)
Perseverative Thinking Questionnaire (PTQ)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Patient Specific Functional Scale (PSFS)
Patient Specific Functional Scale (PSFS) * five daily important activities are rated on a 11-point scale * min. 0 (worse outcome) / max. 10 (better outcome)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
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change in The World Health Organisation- Five Well-Being Index (WHO-5)
The World Health Organisation- Five Well-Being Index (WHO-5)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Big Five Inventory-SocioOeconomicPanel (BFI-S)
Big Five Inventory-SocioOeconomicPanel (BFI-S)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Questionnaire Subgroups for Targeted Treatment (STarT-G)
Subgroups for Targeted Treatment (STarT-G)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months