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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    400
  • sponsor
    Ruhr University of Bochum
Updated on 10 October 2022

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.

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.

Details
Condition Chronic Low-back Pain (cLBP)
Treatment radial extracorporeal shockwave therapy_4000_20, radial extracorporeal shockwave therapy_500_2, standard multimodal pain therapy
Clinical Study IdentifierNCT05308641
SponsorRuhr University of Bochum
Last Modified on10 October 2022

Eligibility

Yes No Not Sure

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
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