Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain
- Conditions
- Chronic Low-back Pain (cLBP)
- Interventions
- Procedure: standard multimodal pain therapyProcedure: radial extracorporeal shockwave therapy_500_2Procedure: radial extracorporeal shockwave therapy_4000_20
- Registration Number
- NCT05308641
- Lead Sponsor
- Ruhr University of Bochum
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- chronic lumbar back pain of min 3 months duration
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PrevSurg_NO/rESWT_no standard multimodal pain therapy Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: no PrevSurg_NO/rESWT_4000 standard multimodal pain therapy Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 4000 pulse, 20 Hz PrevSurg_YES/rESWT_500 standard multimodal pain therapy Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 500 pulse, 2 Hz PrevSurg_YES/rESWT_deny standard multimodal pain therapy Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: denied PrevSurg_YES/rESWT_500 radial extracorporeal shockwave therapy_500_2 Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 500 pulse, 2 Hz PrevSurg_YES/rESWT_no standard multimodal pain therapy Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: no PrevSurg_NO/rESWT_4000 radial extracorporeal shockwave therapy_4000_20 Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 4000 pulse, 20 Hz PrevSurg_NO/rESWT_500 radial extracorporeal shockwave therapy_500_2 Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 500 pulse, 2 Hz PrevSurg_NO/rESWT_500 standard multimodal pain therapy Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 500 pulse, 2 Hz PreviousSurgery(PrevSurg)_YES/rESWT_4000 radial extracorporeal shockwave therapy_4000_20 Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 4000 pulse, 20 Hz PreviousSurgery(PrevSurg)_YES/rESWT_4000 standard multimodal pain therapy Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 4000 pulse, 20 Hz PrevSurg_NO/rESWT_deny standard multimodal pain therapy Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: denied
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method change in Oswestry Disability Index (ODI) pre-intervention, 2 weeks, 1 month, 3 months, 6 months Oswestry Disability Index (ODI)
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 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)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 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 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)
Trial Locations
- Locations (1)
Klinik Blankenstein
🇩🇪Hattingen, Germany