Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2017-11-08
2019-01-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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shockwave therapy
shockwave therapy
shockwave therapy
Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week
Placebo treatment
sham shockwave therapy by an identically looking device without any function
placebo shockwave therapy
sham shockwave therapy by an identically looking device without any function
Interventions
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shockwave therapy
Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week
placebo shockwave therapy
sham shockwave therapy by an identically looking device without any function
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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University Hospital Muenster
OTHER
Responsible Party
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Niklas Deventer
Dr. med. Niklas Deventer
Principal Investigators
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Niklas Deventer, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie
Tobias Schulte, Prof. Dr. med.
Role: STUDY_DIRECTOR
Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum
Tobias Lange, Dr. med., MBA
Role: PRINCIPAL_INVESTIGATOR
Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum
Locations
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Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie
Münster, North Rhine-Westphalia, Germany
Countries
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References
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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.
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.
Other Identifiers
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Orth-001
Identifier Type: -
Identifier Source: org_study_id
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