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

NCT02487368 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2015-07-02

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Low Back Pain
  • Recurrent Low Back Pain

Interventions

DEVICE

Needle stimulation pad

Sponsors & Collaborators

  • Siemens-Betriebskrankenkasse

    collaborator INDUSTRY

  • Universität Duisburg-Essen

    lead OTHER

Principal Investigators

  • Gustav Dobos, Professor · University of Duisburg-Essen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-12-31
Completion
2010-12-31

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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 NCT02487368 on ClinicalTrials.gov