Low Back PainNCT01132300
Efficacy Study Image Guided, Auto-Targeted Neurostimulation for the Treatment of Non-Specific Low Back Pain
A study testing Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st) in people with Low Back Pain, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is: Initial evaluation of the clinical effectiveness of Image Guided Transcutaneous Electrical Stimulation (TENS) device for treatment of non-specific low back pain. To assess the tolerability and acceptability of the device by the caregiver ("User Friendly"). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2009to Feb 2010
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-specific low back pain persisted at least 1 month and no longer than 12 month before the study
- Patients must have a baseline score>40 mm on the VAS pain scale
- If taking analgesics, patients must agree to maintain a steady regimen for the duration of the study.
- Able to provide written and verbal informed consent.
Who cannot join
- Sciatica
- Diagnosed spinal stenosis
- Back Pain potentially attributable to specific underlying diseases or conditions (e.g. pregnancy, metastatic cancer, spondylolisthesis, fractured bones, dislocated joints, disc eruption).
- Unstable medical or severe psychiatric conditions or dementia.
- Previous Back surgery
- Physically unable to undergo treatment
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- Patients receiving workers compensation or those involved in litigation
- Minimal pain - less than 40mm score on VAS scale
- History of pacemaker , implantable devices, history of cardiac arrhythmias
- Allergy or intolerance to adhesive materials
- Clinical evidence of cardiovascular, pulmonary, renal, hepatic, neurological , hematological or endocrine abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Trial Evaluating Efficacy of NeMa-st - A Computerized, Image Guided, Auto-Targeted Neurostimulation Device for the Treatment of Non Specific Low Back Pain
The purpose of this study is:
- Initial evaluation of the clinical effectiveness of Image Guided Transcutaneous Electrical Stimulation (TENS) device for treatment of non-specific low back pain.
- To assess the tolerability and acceptability of the device by the caregiver ("User Friendly").
- To evaluate patients' tolerance by monitoring side effects and tolerability during treatment.
Read the detailed description
Transcutaneous electrical nerves stimulation (TENS) devices are a drug-free alternative for managing pain. For the past thirty years, doctors have been prescribing FDA approved TENS worldwide as an effective way to relieve pain. TENS device currently utilized includes a variety of types of devices and pulse modulations. Most of these devices are applied on large surface areas, and are designed to block the pain signal (gate mechanism) to the brain. Others manual TENS devices are applied to small surface areas to stimulate peripheral nerve ends, and by that causing the release of endorphins with a significantly superior clinical outcome. Such treatments are time consuming and cumbersome and requires previous knowledge of location of nerve ends.
A novel device capable of scanning a large skin surface area, automatically locating nerve ends responsible for pain relief by utilizing skin impedance measurements and image processing with anatomical matching will be tested for stimulating these peripheral nerve ends (NeMa-st, Nervomatrix Ltd., Netanya, Israel).
For this purpose an open study to initially evaluate safety and efficacy of the intervention is designed. 20 patients will undergo 2 treatment sessions per week for a period of 4 weeks, while maintaining their pain relief medication treatment regime.
- Conditions
- Low Back Pain
- Being tested
- Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st)
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st)Device
Also called Nervomatrix Ltd. Auto-Targeted Neurostimulation, NeMa-st
Patients will undergo 2 treatments per week during 4 weeks using the device. During the study Patients are allowed to maintain/continue taking medications/ analgesics for pain relief prescribed to them before the study. Medication use will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale Pain Questionnaire (VAS)
Measured: Baseline, before, and two hours after treatment session, 2 times a week, up to 5 weeks
Secondary outcomes (3)
Oswestry Disability Questionnaire
Measured: once a week during the study, up to 5 weeks
Side effect record
Measured: after each treatment session, 2 times a week, up to 5 weeks
Range of Motion - lower back and pelvic forward flexion
Measured: Baseline, once a week, up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startJul 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Collaborators
- Nervomatrix Ltd. Israel
- Investigators
- Elad Schiff, MD, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132300
- Sponsor's protocol ID
- Approval Pending
- Status last verified
- May 2010
- First submitted
- 15 Sep 2009
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Trial Evaluating Efficacy of NeMa-st - A Computerized, Image Guided, Auto-Targeted Neurostimulation Device for the Treatment of Non Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT01132300
- Acronym / sponsor ID
- Approval Pending
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Collaborators
- Nervomatrix Ltd. Israel
- Study start
- Jul 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 28 May 2010 (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.
The purpose of this study is:
- Initial evaluation of the clinical effectiveness of Image Guided Transcutaneous Electrical Stimulation (TENS) device for treatment of non-specific low back pain.
- To assess the tolerability and acceptability of the device by the caregiver ("User Friendly").
- To evaluate patients' tolerance by monitoring side effects and tolerability during treatment.
Detailed description
Transcutaneous electrical nerves stimulation (TENS) devices are a drug-free alternative for managing pain. For the past thirty years, doctors have been prescribing FDA approved TENS worldwide as an effective way to relieve pain. TENS device currently utilized includes a variety of types of devices and pulse modulations. Most of these devices are applied on large surface areas, and are designed to block the pain signal (gate mechanism) to the brain. Others manual TENS devices are applied to small surface areas to stimulate peripheral nerve ends, and by that causing the release of endorphins with a significantly superior clinical outcome. Such treatments are time consuming and cumbersome and requires previous knowledge of location of nerve ends.
A novel device capable of scanning a large skin surface area, automatically locating nerve ends responsible for pain relief by utilizing skin impedance measurements and image processing with anatomical matching will be tested for stimulating these peripheral nerve ends (NeMa-st, Nervomatrix Ltd., Netanya, Israel).
For this purpose an open study to initially evaluate safety and efficacy of the intervention is designed. 20 patients will undergo 2 treatment sessions per week for a period of 4 weeks, while maintaining their pain relief medication treatment regime.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-specific low back pain persisted at least 1 month and no longer than 12 month before the study
- Patients must have a baseline score>40 mm on the VAS pain scale
- If taking analgesics, patients must agree to maintain a steady regimen for the duration of the study.
- Able to provide written and verbal informed consent.
Key exclusion criteria (11 listed)
- Sciatica
- Diagnosed spinal stenosis
- Back Pain potentially attributable to specific underlying diseases or conditions (e.g. pregnancy, metastatic cancer, spondylolisthesis, fractured bones, dislocated joints, disc eruption).
- Unstable medical or severe psychiatric conditions or dementia.
- Previous Back surgery
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 |
|---|---|---|
| Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st)Also: Nervomatrix Ltd. Auto-Targeted Neurostimulation, NeMa-stPatients will undergo 2 treatments per week during 4 weeks using the device. During the study Patients are allowed to maintain/continue taking medications/ analgesics for pain relief prescribed to them before the study. Medication use will be recorded. | Device | Treatment |
Primary outcome
Visual Analogue Scale Pain Questionnaire (VAS)
Time frame: Baseline, before, and two hours after treatment session, 2 times a week, up to 5 weeks
3 secondary outcomes
Oswestry Disability Questionnaire
Time frame: once a week during the study, up to 5 weeks
Side effect record
Time frame: after each treatment session, 2 times a week, up to 5 weeks
Range of Motion - lower back and pelvic forward flexion
Time frame: Baseline, once a week, up to 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
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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.
Elad Schiff, MD principal investigator
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st) in people with Low Back Pain, run by Bnai Zion Medical Center at 1 site in Israel.
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 4 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: finished, as of the sponsor's last update on 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale Pain Questionnaire (VAS) (time frame: Baseline, before, and two hours after treatment session, 2 times a week, up to 5 weeks). 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 28 May 2010.