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

Primary Purpose

Chronic Low-back Pain (cLBP)

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
radial extracorporeal shockwave therapy_4000_20
radial extracorporeal shockwave therapy_500_2
standard multimodal pain therapy
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain (cLBP) focused on measuring radial shockwave therapy, chronic low back pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Klinik BlankensteinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

PreviousSurgery(PrevSurg)_YES/rESWT_4000

PrevSurg_YES/rESWT_500

PrevSurg_YES/rESWT_no

PrevSurg_YES/rESWT_deny

PrevSurg_NO/rESWT_4000

PrevSurg_NO/rESWT_500

PrevSurg_NO/rESWT_no

PrevSurg_NO/rESWT_deny

Arm Description

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

change in Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI)
change in European Quality of Life 5 Dimensions (EQ5D)
European Quality of Life 5 Dimensions (EQ5D)
change in Pain Self-Efficacy Questionnaire (PSEQ)
Pain Self-Efficacy Questionnaire (PSEQ)
change in Patient Health Questionnaire-9 (PHQ-9)
Patient Health Questionnaire-9 (PHQ-9)
change in Perseverative Thinking Questionnaire (PTQ)
Perseverative Thinking Questionnaire (PTQ)
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)
change in The World Health Organisation- Five Well-Being Index (WHO-5)
The World Health Organisation- Five Well-Being Index (WHO-5)
change in Big Five Inventory-SocioOeconomicPanel (BFI-S)
Big Five Inventory-SocioOeconomicPanel (BFI-S)
change in Questionnaire Subgroups for Targeted Treatment (STarT-G)
Subgroups for Targeted Treatment (STarT-G)

Full Information

First Posted
March 15, 2022
Last Updated
September 18, 2022
Sponsor
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT05308641
Brief Title
Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain
Acronym
ShockEffect
Official Title
Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain - Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain (cLBP)
Keywords
radial shockwave therapy, chronic low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PreviousSurgery(PrevSurg)_YES/rESWT_4000
Arm Type
Active Comparator
Arm Description
Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 4000 pulse, 20 Hz
Arm Title
PrevSurg_YES/rESWT_500
Arm Type
Active Comparator
Arm Description
Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 500 pulse, 2 Hz
Arm Title
PrevSurg_YES/rESWT_no
Arm Type
Active Comparator
Arm Description
Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: no
Arm Title
PrevSurg_YES/rESWT_deny
Arm Type
Active Comparator
Arm Description
Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: denied
Arm Title
PrevSurg_NO/rESWT_4000
Arm Type
Active Comparator
Arm Description
Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 4000 pulse, 20 Hz
Arm Title
PrevSurg_NO/rESWT_500
Arm Type
Active Comparator
Arm Description
Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 500 pulse, 2 Hz
Arm Title
PrevSurg_NO/rESWT_no
Arm Type
Active Comparator
Arm Description
Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: no
Arm Title
PrevSurg_NO/rESWT_deny
Arm Type
Active Comparator
Arm Description
Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: denied
Intervention Type
Procedure
Intervention Name(s)
radial extracorporeal shockwave therapy_4000_20
Intervention Description
application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz
Intervention Type
Procedure
Intervention Name(s)
radial extracorporeal shockwave therapy_500_2
Intervention Description
application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz
Intervention Type
Procedure
Intervention Name(s)
standard multimodal pain therapy
Intervention Description
standard multimodal pain therapy
Primary Outcome Measure Information:
Title
change in Numeric Rating Scale (NRS)
Description
Pain intensity measured by Numeric Rating Scale (NRS) - 11-point scale / min. 0 (better outcome) / max. 10 (worse outcome)
Time Frame
pre-intervention, 2 weeks, 1 month, 3 months, 6 months
Secondary Outcome Measure Information:
Title
change in Oswestry Disability Index (ODI)
Description
Oswestry Disability Index (ODI)
Time Frame
pre-intervention, 2 weeks, 1 month, 3 months, 6 months
Title
change in European Quality of Life 5 Dimensions (EQ5D)
Description
European Quality of Life 5 Dimensions (EQ5D)
Time Frame
pre-intervention, 2 weeks, 1 month, 3 months, 6 months
Title
change in Pain Self-Efficacy Questionnaire (PSEQ)
Description
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame
pre-intervention, 2 weeks, 1 month, 3 months, 6 months
Title
change in Patient Health Questionnaire-9 (PHQ-9)
Description
Patient Health Questionnaire-9 (PHQ-9)
Time Frame
pre-intervention, 2 weeks, 1 month, 3 months, 6 months
Title
change in Perseverative Thinking Questionnaire (PTQ)
Description
Perseverative Thinking Questionnaire (PTQ)
Time Frame
pre-intervention, 2 weeks, 1 month, 3 months, 6 months
Title
change in Patient Specific Functional Scale (PSFS)
Description
Patient Specific Functional Scale (PSFS) five daily important activities are rated on a 11-point scale min. 0 (worse outcome) / max. 10 (better outcome)
Time Frame
pre-intervention, 2 weeks, 1 month, 3 months, 6 months
Title
change in The World Health Organisation- Five Well-Being Index (WHO-5)
Description
The World Health Organisation- Five Well-Being Index (WHO-5)
Time Frame
pre-intervention, 2 weeks, 1 month, 3 months, 6 months
Title
change in Big Five Inventory-SocioOeconomicPanel (BFI-S)
Description
Big Five Inventory-SocioOeconomicPanel (BFI-S)
Time Frame
pre-intervention, 2 weeks, 1 month, 3 months, 6 months
Title
change in Questionnaire Subgroups for Targeted Treatment (STarT-G)
Description
Subgroups for Targeted Treatment (STarT-G)
Time Frame
pre-intervention, 2 weeks, 1 month, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Lange, MD
Phone
+49 234 509 6502
Email
tobias.lange@klinikum-bochum.de
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Rehbein
Phone
+49 234 509 6510
Email
lisa.rehbein@klinikum-bochum.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias L Schulte, Prof
Organizational Affiliation
Department of Orthopaedics and Trauma Surgery, St. Josef-Hospital, Ruhr-University Bochum
Official's Role
Study Director
Facility Information:
Facility Name
Klinik Blankenstein
City
Hattingen
ZIP/Postal Code
45527
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvia Schreyer, MD
First Name & Middle Initial & Last Name & Degree
Sylvia Schreyer, MD
First Name & Middle Initial & Last Name & Degree
Tayna Greiling

12. IPD Sharing Statement

Citations:
PubMed Identifier
34884271
Citation
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8658438/pdf/jcm-10-05569.pdf
Description
Related Info

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

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