Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain
NCT ID: NCT02487368
Last Updated: 2015-07-02
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
166 participants
INTERVENTIONAL
2009-10-31
2010-12-31
Brief Summary
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Patients with non-specific chronic or recurrent low back pain were selected from a large health insurance company database and advised to use the pad daily for two weeks; outcomes were assessed at baseline, weeks 2 and 14. Primary outcome measure was pain intensity at week 2; secondary outcome measures included the Oswestry disability index (ODI), health-related quality of life (SF-36), the fear avoidance beliefs questionnaire (FABQ), analgesic medication consumption and safety.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Needle stimulation pad
a self-administered treatment with a mechanical needle stimulation pad, a mechanical device to be used for 30 minutes daily for 14 days.
Needle stimulation pad
Interventions
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Needle stimulation pad
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* average pain intensity 4 out of 10 points
Exclusion Criteria
* congenital deformities of the spine
* dystonia or other movement disorders
* spinal surgery within 12 months prior
* pregnancy
* dermatological diseases in the areas treated
* tendency for hemorrhages
* severe mental illness
* recent treatment with anticoagulation, corticoid medication, acupuncture
18 Years
75 Years
ALL
No
Sponsors
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Siemens-Betriebskrankenkasse
INDUSTRY
Universität Duisburg-Essen
OTHER
Responsible Party
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Gustav Dobos
Principle Investigator
Principal Investigators
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Gustav Dobos, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Duisburg-Essen
Other Identifiers
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NRM_2009
Identifier Type: -
Identifier Source: org_study_id
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