Non Invasive Brain Stimulation Treatment for CLBP

Not Applicable

• Conditions: Chronic Low Back Pain (CLBP)
• Interventions: Device: NIBS system for evaluation and treatment utilizing non invasive brain stimulation

• Registration Number: NCT02615418
• Lead Sponsor: NIBS NeuroScience Technologies

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-11
• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Last Update Submitted: 2015-11-26
• Last Update Posted: 2015-11-30
• Study Start: 2016-01
• Primary Completion: 2017-01
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fully active treatement	NIBS system for evaluation and treatment utilizing non invasive brain stimulation	-
partially active	NIBS system for evaluation and treatment utilizing non invasive brain stimulation	first 2.5 weeks will receive sham treatment followed by active

Primary Outcome Measures

Name	Time	Method
Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS)	Baseline to week 6 .

Secondary Outcome Measures

Name	Time	Method
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