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

Ruhr University of Bochum

Status: Enrolling

Conditions: Chronic Low-back Pain (cLBP)

Treatments: Procedure: radial extracorporeal shockwave therapy_500_2; Procedure: radial extracorporeal shockwave therapy_4000_20; Procedure: standard multimodal pain therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05308641

1_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 8 patient groups

PreviousSurgery(PrevSurg)_YES/rESWT_4000

Active Comparator group

Description:

Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 4000 pulse, 20 Hz

Treatment:

Procedure: standard multimodal pain therapy

Procedure: radial extracorporeal shockwave therapy_4000_20

PrevSurg_YES/rESWT_500

Active Comparator group

Description:

Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 500 pulse, 2 Hz

Treatment:

Procedure: standard multimodal pain therapy

Procedure: radial extracorporeal shockwave therapy_500_2

PrevSurg_YES/rESWT_no

Active Comparator group

Description:

Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: no

Treatment:

Procedure: standard multimodal pain therapy

PrevSurg_YES/rESWT_deny

Active Comparator group

Description:

Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: denied

Treatment:

Procedure: standard multimodal pain therapy

PrevSurg_NO/rESWT_4000

Active Comparator group

Description:

Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 4000 pulse, 20 Hz

Treatment:

Procedure: standard multimodal pain therapy

Procedure: radial extracorporeal shockwave therapy_4000_20

PrevSurg_NO/rESWT_500

Active Comparator group

Description:

Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 500 pulse, 2 Hz

Treatment:

Procedure: standard multimodal pain therapy

Procedure: radial extracorporeal shockwave therapy_500_2

PrevSurg_NO/rESWT_no

Active Comparator group

Description:

Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: no

Treatment:

Procedure: standard multimodal pain therapy

PrevSurg_NO/rESWT_deny

Active Comparator group

Description:

Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: denied

Treatment:

Procedure: standard multimodal pain therapy