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

NCT ID: NCT05308641

Last Updated: 2025-04-06

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-18

Study Completion Date

2025-12-07

Brief Summary

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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

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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

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Chronic Low-back Pain (cLBP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

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

Group Type ACTIVE_COMPARATOR

radial extracorporeal shockwave therapy_4000_20

Intervention Type PROCEDURE

application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz

standard multimodal pain therapy

Intervention Type PROCEDURE

standard multimodal pain therapy

PrevSurg_YES/rESWT_500

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

Group Type ACTIVE_COMPARATOR

radial extracorporeal shockwave therapy_500_2

Intervention Type PROCEDURE

application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz

standard multimodal pain therapy

Intervention Type PROCEDURE

standard multimodal pain therapy

PrevSurg_YES/rESWT_no

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

Group Type ACTIVE_COMPARATOR

standard multimodal pain therapy

Intervention Type PROCEDURE

standard multimodal pain therapy

PrevSurg_YES/rESWT_deny

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

Group Type ACTIVE_COMPARATOR

standard multimodal pain therapy

Intervention Type PROCEDURE

standard multimodal pain therapy

PrevSurg_NO/rESWT_4000

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

Group Type ACTIVE_COMPARATOR

radial extracorporeal shockwave therapy_4000_20

Intervention Type PROCEDURE

application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz

standard multimodal pain therapy

Intervention Type PROCEDURE

standard multimodal pain therapy

PrevSurg_NO/rESWT_500

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

Group Type ACTIVE_COMPARATOR

radial extracorporeal shockwave therapy_500_2

Intervention Type PROCEDURE

application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz

standard multimodal pain therapy

Intervention Type PROCEDURE

standard multimodal pain therapy

PrevSurg_NO/rESWT_no

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

Group Type ACTIVE_COMPARATOR

standard multimodal pain therapy

Intervention Type PROCEDURE

standard multimodal pain therapy

PrevSurg_NO/rESWT_deny

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

Group Type ACTIVE_COMPARATOR

standard multimodal pain therapy

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

radial extracorporeal shockwave therapy_500_2

application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz

Intervention Type PROCEDURE

standard multimodal pain therapy

standard multimodal pain therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Tobias Lange, MBA

Principal Investigator

Responsibility Role 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

Site Status

Countries

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Germany

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.

Reference Type RESULT
PMID: 34884271 (View on PubMed)

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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