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Shockwave Therapy for Acute Low Back Pain

NCT02253771 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2021-02-02

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

shockwave therapy

Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week

DEVICE

placebo shockwave therapy

sham shockwave therapy by an identically looking device without any function

Sponsors & Collaborators

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Niklas Deventer, Dr. med. · Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie

  • Tobias Schulte, Prof. Dr. med. · Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum

  • Tobias Lange, Dr. med., MBA · Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-08
Primary Completion
2018-09-13
Completion
2019-01-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02253771 on ClinicalTrials.gov