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Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain (NRM_2009)

Primary Purpose

Chronic Low Back Pain, Recurrent Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Needle stimulation pad
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Needle stimulation pad

    Arm Description

    a self-administered treatment with a mechanical needle stimulation pad, a mechanical device to be used for 30 minutes daily for 14 days.

    Outcomes

    Primary Outcome Measures

    Pain intensity
    Visual analogue scale

    Secondary Outcome Measures

    Pain intensity
    Visual analogue scale
    Oswestry Low Back Pain Disability Index
    Oswestry Low Back Pain Disability Index
    Short Form 36 Health Survey Questionnaire (SF-36)
    Short Form 36 Health Survey Questionnaire (SF-36)
    Fear Avoidance Beliefs Questionnaire (FABQ)
    Fear Avoidance Beliefs Questionnaire (FABQ)
    Experiences with the intervention
    Open question: "please indicate observed changes"
    Medication use
    Use of medication, daily log
    Number of any adverse events
    Pain intensity measured immediately after the application, visual analogue scale

    Full Information

    First Posted
    June 29, 2015
    Last Updated
    July 1, 2015
    Sponsor
    Universität Duisburg-Essen
    Collaborators
    Siemens-Betriebskrankenkasse
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02487368
    Brief Title
    Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain
    Acronym
    NRM_2009
    Official Title
    Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universität Duisburg-Essen
    Collaborators
    Siemens-Betriebskrankenkasse

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed Description
    see above

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Low Back Pain, Recurrent Low Back Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    166 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Needle stimulation pad
    Arm Type
    Experimental
    Arm Description
    a self-administered treatment with a mechanical needle stimulation pad, a mechanical device to be used for 30 minutes daily for 14 days.
    Intervention Type
    Device
    Intervention Name(s)
    Needle stimulation pad
    Other Intervention Name(s)
    Shakti mat, Bed of nails
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    Visual analogue scale
    Time Frame
    day 14
    Secondary Outcome Measure Information:
    Title
    Pain intensity
    Description
    Visual analogue scale
    Time Frame
    Week 14
    Title
    Oswestry Low Back Pain Disability Index
    Time Frame
    Day 14
    Title
    Oswestry Low Back Pain Disability Index
    Time Frame
    Week 14
    Title
    Short Form 36 Health Survey Questionnaire (SF-36)
    Time Frame
    Day 14
    Title
    Short Form 36 Health Survey Questionnaire (SF-36)
    Time Frame
    Week 14
    Title
    Fear Avoidance Beliefs Questionnaire (FABQ)
    Time Frame
    Day 14
    Title
    Fear Avoidance Beliefs Questionnaire (FABQ)
    Time Frame
    Week 14
    Title
    Experiences with the intervention
    Description
    Open question: "please indicate observed changes"
    Time Frame
    Day 14
    Title
    Medication use
    Description
    Use of medication, daily log
    Time Frame
    Day 14
    Title
    Number of any adverse events
    Time Frame
    Day 14
    Title
    Pain intensity measured immediately after the application, visual analogue scale
    Time Frame
    5 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gustav Dobos, Professor
    Organizational Affiliation
    University of Duisburg-Essen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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