A Novel Non Invasive Brain Stimulation,tDCS Based Treatment for Chronic Low Back Pain (CLBP)-Sourasky Medical Center-Tel Aviv

NIBS NeuroScience Technologies0 sites60 target enrollmentJanuary 2016

ConditionsChronic Low Back Pain (CLBP)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Low Back Pain (CLBP)
Sponsor: NIBS NeuroScience Technologies
Enrollment: 60
Primary Endpoint: Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS)
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

July 2017

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

NIBS NeuroScience Technologies

Responsible Party

Sponsor

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
•Illicit drug use or within the previous month

Outcomes

Primary Outcomes

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

Time Frame: Baseline to week 6 .

Secondary Outcomes

Change From Baseline in Sleep Quality (0-10 Numerical Rating Scale Scores)(Baseline to 6 weeks)
Change CLBP quality of life -Roland-Morris questionnaire(Baseline to 6 weeks)