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

R

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

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

Trial contacts and locations

1

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Central trial contact

Lisa Rehbein; Tobias Lange, MD

Data sourced from clinicaltrials.gov

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