NCT05308641

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Ruhr University of Bochum · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Low-back Pain (cLBP)

Interventions

Type	Name	Description
PROCEDURE	radial extracorporeal shockwave therapy_4000_20	application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz
PROCEDURE	radial extracorporeal shockwave therapy_500_2	application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz
PROCEDURE	standard multimodal pain therapy	standard multimodal pain therapy

Timeline

• Start date: 2022-09-18
• Primary completion: 2024-12-31
• Completion: 2025-12-07
• First posted: 2022-04-04
• Last updated: 2025-04-06

Locations

1 site across 1 country: Germany