Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain - Randomized Controlled Trial

Conditions
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Chronic Low-back Pain (cLBP)

Intervention / Treatment
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* Procedure: radial extracorporeal shockwave therapy_4000_20
* Procedure: radial extracorporeal shockwave therapy_500_2
* Procedure: standard multimodal pain therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PreviousSurgery(PrevSurg)_YES/rESWT_4000<br>Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 4000 pulse, 20 Hz | Procedure: radial extracorporeal shockwave therapy_4000_20<br>* application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz<br>Procedure: standard multimodal pain therapy<br>* standard multimodal pain therapy<br>|
| Active Comparator: PrevSurg_YES/rESWT_500<br>Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 500 pulse, 2 Hz | Procedure: radial extracorporeal shockwave therapy_500_2<br>* application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz<br>Procedure: standard multimodal pain therapy<br>* standard multimodal pain therapy<br>|
| Active Comparator: PrevSurg_YES/rESWT_no<br>Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: no | Procedure: standard multimodal pain therapy<br>* standard multimodal pain therapy<br>|
| Active Comparator: PrevSurg_YES/rESWT_deny<br>Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: denied | Procedure: standard multimodal pain therapy<br>* standard multimodal pain therapy<br>|
| Active Comparator: PrevSurg_NO/rESWT_4000<br>Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 4000 pulse, 20 Hz | Procedure: radial extracorporeal shockwave therapy_4000_20<br>* application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz<br>Procedure: standard multimodal pain therapy<br>* standard multimodal pain therapy<br>|
| Active Comparator: PrevSurg_NO/rESWT_500<br>Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 500 pulse, 2 Hz | Procedure: radial extracorporeal shockwave therapy_500_2<br>* application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz<br>Procedure: standard multimodal pain therapy<br>* standard multimodal pain therapy<br>|
| Active Comparator: PrevSurg_NO/rESWT_no<br>Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: no | Procedure: standard multimodal pain therapy<br>* standard multimodal pain therapy<br>|
| Active Comparator: PrevSurg_NO/rESWT_deny<br>Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: denied | Procedure: standard multimodal pain therapy<br>* standard multimodal pain therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) five daily important activities are rated on a 11-point scale min. 0 (worse outcome) / max. 10 (better outcome) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radial shockwave therapy, chronic low back pain