Chronic Low Back Pain (CLBP) Clinical Trial
— NIBSTCLBPOfficial title:
A Novel Non Invasive Brain Stimulation,tDCS Based Treatment for Chronic Low Back Pain (CLBP)-Sourasky Medical Center-Tel Aviv
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | July 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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NIBS NeuroScience Technologies |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS) | Baseline to week 6 . | ||
Secondary | Change From Baseline in Sleep Quality (0-10 Numerical Rating Scale Scores) | Baseline to 6 weeks | ||
Secondary | Change CLBP quality of life -Roland-Morris questionnaire | Baseline to 6 weeks |
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