Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain
NCT ID: NCT05308641
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
400 participants
INTERVENTIONAL
2022-09-18
2025-12-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PreviousSurgery(PrevSurg)_YES/rESWT_4000
Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 4000 pulse, 20 Hz
radial extracorporeal shockwave therapy_4000_20
application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz
standard multimodal pain therapy
standard multimodal pain therapy
PrevSurg_YES/rESWT_500
Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 500 pulse, 2 Hz
radial extracorporeal shockwave therapy_500_2
application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz
standard multimodal pain therapy
standard multimodal pain therapy
PrevSurg_YES/rESWT_no
Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: no
standard multimodal pain therapy
standard multimodal pain therapy
PrevSurg_YES/rESWT_deny
Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: denied
standard multimodal pain therapy
standard multimodal pain therapy
PrevSurg_NO/rESWT_4000
Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 4000 pulse, 20 Hz
radial extracorporeal shockwave therapy_4000_20
application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz
standard multimodal pain therapy
standard multimodal pain therapy
PrevSurg_NO/rESWT_500
Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 500 pulse, 2 Hz
radial extracorporeal shockwave therapy_500_2
application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz
standard multimodal pain therapy
standard multimodal pain therapy
PrevSurg_NO/rESWT_no
Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: no
standard multimodal pain therapy
standard multimodal pain therapy
PrevSurg_NO/rESWT_deny
Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: denied
standard multimodal pain therapy
standard multimodal pain therapy
Interventions
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radial extracorporeal shockwave therapy_4000_20
application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz
radial extracorporeal shockwave therapy_500_2
application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz
standard multimodal pain therapy
standard multimodal pain therapy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Ruhr University of Bochum
OTHER
Responsible Party
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Dr. med. Tobias Lange, MBA
Principal Investigator
Principal Investigators
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Tobias L Schulte, Prof
Role: STUDY_DIRECTOR
Department of Orthopaedics and Trauma Surgery, St. Josef-Hospital, Ruhr-University Bochum
Locations
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Klinik Blankenstein
Hattingen, , Germany
Countries
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References
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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.
Related Links
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Other Identifiers
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1_1
Identifier Type: -
Identifier Source: org_study_id
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