Chronic Low Back Pain (CLBP)NIBSTCLBPNCT02615418
Non Invasive Brain Stimulation Treatment for CLBP
A study testing NIBS system for evaluation and treatment utilizing non invasive brain stimulation in people with Chronic Low Back Pain (CLBP), run by NIBS NeuroScience Technologies.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- NIBS system for evaluation and treatment utilizing non invasive brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80
- CLBP as defined by the European guidelines.
- low back pain first week average NPRS>4.
Who cannot join
- 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
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- History of loss of consciousness
- Epilepsy or epilepsy in a first degree relative
- Medical implants
- Pregnancy
- Illicit drug use or within the previous month
Trial locations and contacts
No sites are listed yet.
Iftach Dolev, PhD contact
About this study
Official 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.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- NIBS system for evaluation and treatment utilizing non invasive brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIBS system for evaluation and treatment utilizing non invasive brain stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Fully active treatement | Active comparator | Not described Receives: Device: NIBS system for evaluation and treatment utilizing non invasive brain stimulation |
| partially active | Sham comparator | first 2.5 weeks will receive sham treatment followed by active Receives: Device: NIBS system for evaluation and treatment utilizing non invasive brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS)
Measured: Baseline to week 6 .
Secondary outcomes (2)
Change From Baseline in Sleep Quality (0-10 Numerical Rating Scale Scores)
Measured: Baseline to 6 weeks
Change CLBP quality of life -Roland-Morris questionnaire
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NIBS NeuroScience Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615418
- Sponsor's protocol ID
- NIBS-Sour-1
- Acronym
- NIBSTCLBP
- Status last verified
- Nov 2015
- First submitted
- 23 Nov 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Non Invasive Brain Stimulation,tDCS Based Treatment for Chronic Low Back Pain (CLBP)-Sourasky Medical Center-Tel Aviv
- ClinicalTrials.gov ID
- NCT02615418
- Acronym / sponsor ID
- NIBSTCLBP / NIBS-Sour-1
- Conditions
- Chronic Low Back Pain (CLBP)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NIBS NeuroScience TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fully active treatement | Active comparator | Device: NIBS system for evaluation and treatment utilizing non invasive brain stimulation |
| partially active | Sham comparator | Device: NIBS system for evaluation and treatment utilizing non invasive brain stimulationfirst 2.5 weeks will receive sham treatment followed by active |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 80
- CLBP as defined by the European guidelines.
- low back pain first week average NPRS>4.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIBS system for evaluation and treatment utilizing non invasive brain stimulation | Device | Fully active treatement, partially active |
Primary outcome
Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS)
Time frame: Baseline to week 6 .
2 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iftach Dolev, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing NIBS system for evaluation and treatment utilizing non invasive brain stimulation in people with Chronic Low Back Pain (CLBP), run by NIBS NeuroScience Technologies.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iftach Dolev, PhD (iftach@nibs.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS) (time frame: Baseline to week 6 .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2015.