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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PreviousSurgery(PrevSurg)_YES/rESWT_4000 | Active Comparator | Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 4000 pulse, 20 Hz |
|
| PrevSurg_YES/rESWT_500 | Active Comparator | Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 500 pulse, 2 Hz |
|
| PrevSurg_YES/rESWT_no | Active Comparator | Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: no |
|
| PrevSurg_YES/rESWT_deny | Active Comparator | Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: denied |
|
| PrevSurg_NO/rESWT_4000 | Active Comparator | Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 4000 pulse, 20 Hz |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radial extracorporeal shockwave therapy_4000_20 | Procedure | application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in Oswestry Disability Index (ODI) | Oswestry Disability Index (ODI) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias L Schulte, Prof | Department of Orthopaedics and Trauma Surgery, St. Josef-Hospital, Ruhr-University Bochum | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Blankenstein | Hattingen | 45527 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34884271 | Result | Lange T, Deventer N, Gosheger G, Lampe LP, Bockholt S, Schulze Boevingloh A, Schulte TL. Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain-Randomized Controlled Trial. J Clin Med. 2021 Nov 26;10(23):5569. doi: 10.3390/jcm10235569. |
| Label | URL |
|---|---|
| Related Info | View source |
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| PrevSurg_NO/rESWT_500 | Active Comparator | Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 500 pulse, 2 Hz |
|
| PrevSurg_NO/rESWT_no | Active Comparator | Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: no |
|
| PrevSurg_NO/rESWT_deny | Active Comparator | Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: denied |
|
| radial extracorporeal shockwave therapy_500_2 | Procedure | application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz |
|
| standard multimodal pain therapy | Procedure | standard multimodal pain therapy |
|
| pre-intervention, 2 weeks, 1 month, 3 months, 6 months |
| change in Pain Self-Efficacy Questionnaire (PSEQ) | Pain Self-Efficacy Questionnaire (PSEQ) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months |
| change in Patient Health Questionnaire-9 (PHQ-9) | Patient Health Questionnaire-9 (PHQ-9) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months |
| change in Perseverative Thinking Questionnaire (PTQ) | Perseverative Thinking Questionnaire (PTQ) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months |
| change in Patient Specific Functional Scale (PSFS) | Patient Specific Functional Scale (PSFS)
| pre-intervention, 2 weeks, 1 month, 3 months, 6 months |
| change in The World Health Organisation- Five Well-Being Index (WHO-5) | The World Health Organisation- Five Well-Being Index (WHO-5) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months |
| change in Big Five Inventory-SocioOeconomicPanel (BFI-S) | Big Five Inventory-SocioOeconomicPanel (BFI-S) | 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) | pre-intervention, 2 weeks, 1 month, 3 months, 6 months |