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Non Invasive Brain Stimulation Treatment for CLBP (NIBSTCLBP)

Primary Purpose

Chronic Low Back Pain (CLBP)

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NIBS system for evaluation and treatment utilizing non invasive brain stimulation
Sponsored by
NIBS NeuroScience Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain (CLBP)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 to 80
  • CLBP as defined by the European guidelines.
  • low back pain first week average NPRS>4.

Exclusion Criteria:

  1. Acute low back pain (duration of less than 6 months) first week average NPRS> 4
  2. Neurological illness causing structural brain damage (e.g. Stroke, TIA)
  3. Psychiatric disease other than mood disorders
  4. Current chronic use of medications with pro-epileptic properties
  5. Known alcohol dependency
  6. Use of alcohol within the previous 24 hours
  7. History of loss of consciousness
  8. Epilepsy or epilepsy in a first degree relative
  9. Medical implants
  10. Pregnancy
  11. Illicit drug use or within the previous month

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Fully active treatement

    partially active

    Arm Description

    first 2.5 weeks will receive sham treatment followed by active

    Outcomes

    Primary Outcome Measures

    Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS)

    Secondary Outcome Measures

    Change From Baseline in Sleep Quality (0-10 Numerical Rating Scale Scores)
    Change CLBP quality of life -Roland-Morris questionnaire

    Full Information

    First Posted
    November 23, 2015
    Last Updated
    November 26, 2015
    Sponsor
    NIBS NeuroScience Technologies
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02615418
    Brief Title
    Non Invasive Brain Stimulation Treatment for CLBP
    Acronym
    NIBSTCLBP
    Official Title
    A Novel Non Invasive Brain Stimulation,tDCS Based Treatment for Chronic Low Back Pain (CLBP)-Sourasky Medical Center-Tel Aviv
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    January 2017 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NIBS NeuroScience Technologies

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This trial is designed to preliminary evaluate the efficacy and safety of NIBS system for treatment of chronic low back pain (CLBP) (over 6 months). The trial is of a double blind sham controlled partial crossover design and will involve 2 weekly treatments and evaluations for 6 weeks, with 6 weeks follow-up. The goal of the study is to 1. Asses the CLBP change immediate and long term effect for the trial duration and follow-up. 2. Asses quality of life improvement as measure by sleep quality and questioners. 3. Asses long term neuronal changes or lack thereof in treated and untreated subjects.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fully active treatement
    Arm Type
    Active Comparator
    Arm Title
    partially active
    Arm Type
    Sham Comparator
    Arm Description
    first 2.5 weeks will receive sham treatment followed by active
    Intervention Type
    Device
    Intervention Name(s)
    NIBS system for evaluation and treatment utilizing non invasive brain stimulation
    Primary Outcome Measure Information:
    Title
    Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS)
    Time Frame
    Baseline to week 6 .
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Sleep Quality (0-10 Numerical Rating Scale Scores)
    Time Frame
    Baseline to 6 weeks
    Title
    Change CLBP quality of life -Roland-Morris questionnaire
    Time Frame
    Baseline to 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 to 80 CLBP as defined by the European guidelines. low back pain first week average NPRS>4. Exclusion Criteria: Acute low back pain (duration of less than 6 months) first week average NPRS> 4 Neurological illness causing structural brain damage (e.g. Stroke, TIA) Psychiatric disease other than mood disorders Current chronic use of medications with pro-epileptic properties Known alcohol dependency Use of alcohol within the previous 24 hours History of loss of consciousness Epilepsy or epilepsy in a first degree relative Medical implants Pregnancy Illicit drug use or within the previous month
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Iftach Dolev, PhD
    Email
    iftach@nibs.co.il

    12. IPD Sharing Statement

    Learn more about this trial

    Non Invasive Brain Stimulation Treatment for CLBP

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