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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain (cLBP)
• Intervention / Treatment: Procedure: radial extracorporeal shockwave therapy_4000_20; Procedure: standard multimodal pain therapy; Procedure: radial extracorporeal shockwave therapy_500_2

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tobias Lange, MD; Phone Number: +49 234 509 6502; Email: tobias.lange@klinikum-bochum.de
• Study Contact Backup: Name: Lisa Rehbein; Phone Number: +49 234 509 6510; Email: lisa.rehbein@klinikum-bochum.de

Study Locations

• Germany
  • Hattingen, Germany, 45527
    • Recruiting
    • Klinik Blankenstein
    • Contact: Sylvia Schreyer, MD
    • Principal Investigator: Sylvia Schreyer, MD
    • Principal Investigator: Tayna Greiling

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / 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: standard multimodal pain therapy; standard multimodal pain therapy; Procedure: radial extracorporeal shockwave therapy_500_2; application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz
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: standard multimodal pain therapy; standard multimodal pain therapy; Procedure: radial extracorporeal shockwave therapy_500_2; application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: chronic low back pain; radial shockwave therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 1_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No