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Shockwave Therapy for Acute Low Back Pain

Primary Purpose

Acute Low Back Pain (Low Back Pain for Less Than 3 Months)

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
shockwave therapy
placebo shockwave therapy
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Low Back Pain (Low Back Pain for Less Than 3 Months)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

low back pain for less than 3 months

Exclusion Criteria:

  • Patients with relevant leg pain
  • Patients with spine operations in the past
  • neurologic symptoms
  • scoliosis with Cobb angle > 10°
  • Patients experienced in shock wave therapy
  • Patientes with ongoing therapy with blood diluting drugs such as phenprocumon
  • Patients with osteoporosis
  • Patients with back pain after trauma
  • Patients with infective diseases or tumor diseases
  • Patients with relevant psychological diseases

Sites / Locations

  • Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

shockwave therapy

Placebo treatment

Arm Description

shockwave therapy

sham shockwave therapy by an identically looking device without any function

Outcomes

Primary Outcome Measures

Change in pain, using visual analogue scale (VAS)
Change in pain, using visual analogue scale (VAS 1-10)

Secondary Outcome Measures

Change in other clinical questionnaires (Oswestry disability Index)
Oswestry disability Index
Change in other clinical questionnaires (Beck's depression scale)
Beck's depression scale
Change in other clinical questionnaires (EQ-5D)
EQ-5D
Change in other clinical questionnaires (Roland-Morris-Score)
Roland-Morris-Score

Full Information

First Posted
August 31, 2014
Last Updated
January 28, 2021
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT02253771
Brief Title
Shockwave Therapy for Acute Low Back Pain
Official Title
Shockwave Therapy for Acute Low Back Pain: a Randomized Placebo-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
September 13, 2018 (Actual)
Study Completion Date
January 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Muenster

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether shockwave therapy is more effective in the treatment of unspecific acute low back pain than sham therapy. 60 patients with acute low back pain will be recruited to a single-blinded, randomized, placebo-controlled trial. They are randomized to receive either shockwave therapy or sham treatment by a identically looking device for 4 weeks, twice a week. Additionally patients receive physiotherapy twice a week and are allowed to take an anti-inflammatory drug, if necessary for even 4 weeks. The primary outcome variable will be measured at day 0, every week during treatment (day 7; 14; 21 and 28) and up to 4 weeks after the last treatment. The clinical outcome will be primarily measured by pain intensity using a visual analogue scale. Secondary outcome measures are Oswestry Disability Index, Beck's Pain Depression Scale, Roland Morris Disability Questionnaire and the EQ-5D. Data will be analysed for the difference in change of scores between groups using one-way t-test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Low Back Pain (Low Back Pain for Less Than 3 Months)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
shockwave therapy
Arm Type
Experimental
Arm Description
shockwave therapy
Arm Title
Placebo treatment
Arm Type
Placebo Comparator
Arm Description
sham shockwave therapy by an identically looking device without any function
Intervention Type
Device
Intervention Name(s)
shockwave therapy
Other Intervention Name(s)
EMS Swiss Dolorclast® Classic (EMS Electro Medical Systems S.a.), CE Certificate: 0124
Intervention Description
Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week
Intervention Type
Device
Intervention Name(s)
placebo shockwave therapy
Intervention Description
sham shockwave therapy by an identically looking device without any function
Primary Outcome Measure Information:
Title
Change in pain, using visual analogue scale (VAS)
Description
Change in pain, using visual analogue scale (VAS 1-10)
Time Frame
Day 0; 7; 14; 21; 28, after 6 and 8 weeks.
Secondary Outcome Measure Information:
Title
Change in other clinical questionnaires (Oswestry disability Index)
Description
Oswestry disability Index
Time Frame
day 0; 7; 14; 21, after 6 and 8 weeks.
Title
Change in other clinical questionnaires (Beck's depression scale)
Description
Beck's depression scale
Time Frame
day 0; 7; 14; 21, after 6 and 8 weeks.
Title
Change in other clinical questionnaires (EQ-5D)
Description
EQ-5D
Time Frame
day 0; 7; 14; 21, after 6 and 8 weeks.
Title
Change in other clinical questionnaires (Roland-Morris-Score)
Description
Roland-Morris-Score
Time Frame
day 0; 7; 14; 21, after 6 and 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: low back pain for less than 3 months Exclusion Criteria: Patients with relevant leg pain Patients with spine operations in the past neurologic symptoms scoliosis with Cobb angle > 10° Patients experienced in shock wave therapy Patientes with ongoing therapy with blood diluting drugs such as phenprocumon Patients with osteoporosis Patients with back pain after trauma Patients with infective diseases or tumor diseases Patients with relevant psychological diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niklas Deventer, Dr. med.
Organizational Affiliation
Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tobias Schulte, Prof. Dr. med.
Organizational Affiliation
Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tobias Lange, Dr. med., MBA
Organizational Affiliation
Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie
City
Münster
State/Province
NRW
ZIP/Postal Code
48149
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
18588702
Citation
Barker KL, Elliott CJ, Sackley CM, Fairbank JC. Treatment of chronic back pain by sensory discrimination training. A Phase I RCT of a novel device (FairMed) vs. TENS. BMC Musculoskelet Disord. 2008 Jun 28;9:97. doi: 10.1186/1471-2474-9-97.
Results Reference
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PubMed Identifier
21482199
Citation
Seco J, Kovacs FM, Urrutia G. The efficacy, safety, effectiveness, and cost-effectiveness of ultrasound and shock wave therapies for low back pain: a systematic review. Spine J. 2011 Oct;11(10):966-77. doi: 10.1016/j.spinee.2011.02.002. Epub 2011 Apr 9.
Results Reference
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Shockwave Therapy for Acute Low Back Pain

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