Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain

NCT ID: NCT02487368

Last Updated: 2015-07-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-12-31

Brief Summary

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The needle stimulation pad is a self-care device, which has been promoted for pain control and well-being. The aim of the study was to test the efficacy of the pad for chronic/recurrent low back pain treatment.

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.

Detailed Description

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see above

Conditions

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Chronic Low Back Pain Recurrent Low Back Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Needle stimulation pad

Intervention Type DEVICE

Interventions

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Needle stimulation pad

Intervention Type DEVICE

Other Intervention Names

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Shakti mat, Bed of nails

Eligibility Criteria

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Inclusion Criteria

* chronic or recurrent low back pain in the past 12 months
* average pain intensity 4 out of 10 points

Exclusion Criteria

* malignant back pain
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siemens-Betriebskrankenkasse

INDUSTRY

Sponsor Role collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Gustav Dobos

Principle Investigator

Responsibility Role PRINCIPAL_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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