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

Sponsor

Ruhr University of Bochum (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05308641

Collaborator

(none)

400

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low-back Pain (cLBP)	Procedure: radial extracorporeal shockwave therapy_4000_20 Procedure: radial extracorporeal shockwave therapy_500_2 Procedure: standard multimodal pain therapy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PreviousSurgery(PrevSurg)_YES/rESWT_4000 Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 4000 pulse, 20 Hz	Procedure: radial extracorporeal shockwave therapy_4000_20 application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz Procedure: standard multimodal pain therapy standard multimodal pain therapy
Active Comparator: PrevSurg_YES/rESWT_500 Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 500 pulse, 2 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
Active Comparator: PrevSurg_YES/rESWT_no Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: no	Procedure: standard multimodal pain therapy standard multimodal pain therapy
Active Comparator: PrevSurg_YES/rESWT_deny Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: denied	Procedure: standard multimodal pain therapy standard multimodal pain therapy
Active Comparator: PrevSurg_NO/rESWT_4000 Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 4000 pulse, 20 Hz	Procedure: radial extracorporeal shockwave therapy_4000_20 application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz Procedure: standard multimodal pain therapy standard multimodal pain therapy
Active Comparator: PrevSurg_NO/rESWT_500 Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 500 pulse, 2 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
Active Comparator: PrevSurg_NO/rESWT_no Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: no	Procedure: standard multimodal pain therapy standard multimodal pain therapy
Active Comparator: PrevSurg_NO/rESWT_deny Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: denied	Procedure: standard multimodal pain therapy standard multimodal pain therapy

Outcome Measures

Primary Outcome Measures

change in Numeric Rating Scale (NRS) [pre-intervention, 2 weeks, 1 month, 3 months, 6 months]
Pain intensity measured by Numeric Rating Scale (NRS) - 11-point scale / min. 0 (better outcome) / max. 10 (worse outcome)

Secondary Outcome Measures

change in Oswestry Disability Index (ODI) [pre-intervention, 2 weeks, 1 month, 3 months, 6 months]
Oswestry Disability Index (ODI)
change in European Quality of Life 5 Dimensions (EQ5D) [pre-intervention, 2 weeks, 1 month, 3 months, 6 months]
European Quality of Life 5 Dimensions (EQ5D)
change in Pain Self-Efficacy Questionnaire (PSEQ) [pre-intervention, 2 weeks, 1 month, 3 months, 6 months]
Pain Self-Efficacy Questionnaire (PSEQ)
change in Patient Health Questionnaire-9 (PHQ-9) [pre-intervention, 2 weeks, 1 month, 3 months, 6 months]
Patient Health Questionnaire-9 (PHQ-9)
change in Perseverative Thinking Questionnaire (PTQ) [pre-intervention, 2 weeks, 1 month, 3 months, 6 months]
Perseverative Thinking Questionnaire (PTQ)
change in Patient Specific Functional Scale (PSFS) [pre-intervention, 2 weeks, 1 month, 3 months, 6 months]
Patient Specific Functional Scale (PSFS) five daily important activities are rated on a 11-point scale min. 0 (worse outcome) / max. 10 (better outcome)
change in The World Health Organisation- Five Well-Being Index (WHO-5) [pre-intervention, 2 weeks, 1 month, 3 months, 6 months]
The World Health Organisation- Five Well-Being Index (WHO-5)
change in Big Five Inventory-SocioOeconomicPanel (BFI-S) [pre-intervention, 2 weeks, 1 month, 3 months, 6 months]
Big Five Inventory-SocioOeconomicPanel (BFI-S)
change in Questionnaire Subgroups for Targeted Treatment (STarT-G) [pre-intervention, 2 weeks, 1 month, 3 months, 6 months]
Subgroups for Targeted Treatment (STarT-G)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ruhr University of Bochum

Investigators

Study Director: Tobias L Schulte, Prof, Department of Orthopaedics and Trauma Surgery, St. Josef-Hospital, Ruhr-University Bochum

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Dr. med. Tobias Lange, MBA, Principal Investigator, Ruhr University of Bochum

ClinicalTrials.gov Identifier:

NCT05308641

Other Study ID Numbers:

First Posted:

Apr 4, 2022

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Dr. med. Tobias Lange, MBA, Principal Investigator, Ruhr University of Bochum

radial shockwave therapy

chronic low back pain

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of Apr 11, 2022