Non Invasive Brain Stimulation Treatment for CLBP

NIBS NeuroScience Technologies60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Low Back Pain (CLBP)

Interventions

NIBS system for evaluation and treatment utilizing non invasive brain stimulationDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

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)

Time frame: Baseline to 6 weeks

Change CLBP quality of life -Roland-Morris questionnaire

Time frame: Baseline to 6 weeks

Central Contacts

Iftach Dolev, PhD

CONTACT

iftach@nibs.co.il

Data from ClinicalTrials.gov

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