Chronic Low-back Pain (cLBP)
Conditions
Keywords
radial shockwave therapy, chronic low back pain
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREradial extracorporeal shockwave therapy_4000_20
application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz
PROCEDUREradial extracorporeal shockwave therapy_500_2
application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz
PROCEDUREstandard multimodal pain therapy
standard multimodal pain therapy
Sponsors
Ruhr University of Bochum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* chronic lumbar back pain of min 3 months duration
Exclusion criteria
* radicular pain of higher intensity than chronic low back pain (cLBP) * new neurologic deficits * anticoagulant therapy * new trauma to the lumbar spine * spine bacterial infection * spine tumor * pregnancy * coagulation disorder * previous infiltration to the lumbar spine within 6 weeks prior to study inclusion * fibromyalgia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Numeric Rating Scale (NRS) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months | Pain intensity measured by Numeric Rating Scale (NRS) \- 11-point scale / min. 0 (better outcome) / max. 10 (worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in European Quality of Life 5 Dimensions (EQ5D) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months | European Quality of Life 5 Dimensions (EQ5D) |
| change in Pain Self-Efficacy Questionnaire (PSEQ) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months | Pain Self-Efficacy Questionnaire (PSEQ) |
| change in Patient Health Questionnaire-9 (PHQ-9) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months | Patient Health Questionnaire-9 (PHQ-9) |
| change in Perseverative Thinking Questionnaire (PTQ) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months | Perseverative Thinking Questionnaire (PTQ) |
| change in Oswestry Disability Index (ODI) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months | Oswestry Disability Index (ODI) |
| change in The World Health Organisation- Five Well-Being Index (WHO-5) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months | The World Health Organisation- Five Well-Being Index (WHO-5) |
| change in Big Five Inventory-SocioOeconomicPanel (BFI-S) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months | Big Five Inventory-SocioOeconomicPanel (BFI-S) |
| change in Questionnaire Subgroups for Targeted Treatment (STarT-G) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months | Subgroups for Targeted Treatment (STarT-G) |
| change in Patient Specific Functional Scale (PSFS) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months | Patient Specific Functional Scale (PSFS) * five daily important activities are rated on a 11-point scale * min. 0 (worse outcome) / max. 10 (better outcome) |
Countries
Germany
Outcome results
None listed