PainNCT02384785
Effectiveness of of Therapeutic Currents in Clinical Dimension and Penetration Depth Dimension in Lower Back
An observational study of Pain, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Electrical stimulation therapy for pain reduction was performed already 2000 years ago. In recent years many studies had proved the effectiveness of electrical stimulation in pain management, tissue healing and muscle strengthening. Today there are devices with many types of currents. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Transcutaneous Electric Nerve Stimulation
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to Dec 2017
- Phase
- Observational
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who undergo electrodes implantation in lumbar spine due to chronic pain. Thease patients arrives 7 days after implantation to the clinic for a procedure of removing the electrodes.
Who may be able to join
- Normal cognitive status.
- language comprehension (understanding and speaking)a way that allows voluntary cooperation in research and compliance with the testing.
Who cannot join
- Pregnant women.
- neurological pathologies (such as -head injury) or other systemic diseases that affect the sensation (such as diabetes).
- Each participant which at any stage in research expresses his wish to resign.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Different Types of Therapeutic Currents in Clinical Dimension and Penetration Depth Dimension in Lower Back
Electrical stimulation therapy for pain reduction was performed already 2000 years ago. In recent years many studies had proved the effectiveness of electrical stimulation in pain management, tissue healing and muscle strengthening. Today there are devices with many types of currents. Each current comes with different statements for its effectiveness and its penetration depth yet there is no consensus on the most effective current in the dimension of penetration depth.
Read the detailed description
The study shall be recruited patients who underwent implantation of electrodes in the spine (Spinal Cord Stimulation- SCS). The electrode will serve as a voltage reader deep in the tissue. The voltage is generated from electrodes applied on the skin and delivers therapeutic currents to the patients back. The study will be tested 4 different types of currents and number of electrode placement.
- Conditions
- Pain
- Being tested
- Transcutaneous Electric Nerve Stimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electric Nerve StimulationDevice
Also called Transcranial Direct Current Stimulation
Electric currents: 'Transcutaneous Electric Nerve Stimulation' and Transcranial Direct Current Stimulation will be applied on the back of the patients in parallel to the implanted electrodes. Implanted electrode will measure voltages that generated near the spinal cord tissue.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation | Patients who underwent implantation of electrodes spine for treatment in chronic pain.
'Transcutaneous Electric Nerve Stimulation' and "Transcranial Direct Current Stimulation" (one after another) Receives: Device: Transcutaneous Electric Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of electric voltage
The amount of electric voltage generated by different types of currents and different electrodes locations
Measured: monitoring voltage takes a few minutes only. Reading Voltage immidiatly- one test only for each current
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startMay 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Moty Mr Ratmansky, MD, Study chair, Site Sub-Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384785
- Sponsor's protocol ID
- SHEBA-12-9941-IGA-CTIL
- Status last verified
- Oct 2016
- First submitted
- 24 Feb 2015
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Types of Therapeutic Currents in Clinical Dimension and Penetration Depth Dimension in Lower Back
- ClinicalTrials.gov ID
- NCT02384785
- Acronym / sponsor ID
- SHEBA-12-9941-IGA-CTIL
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Mar 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.
Electrical stimulation therapy for pain reduction was performed already 2000 years ago. In recent years many studies had proved the effectiveness of electrical stimulation in pain management, tissue healing and muscle strengthening. Today there are devices with many types of currents. Each current comes with different statements for its effectiveness and its penetration depth yet there is no consensus on the most effective current in the dimension of penetration depth.
Detailed description
The study shall be recruited patients who underwent implantation of electrodes in the spine (Spinal Cord Stimulation- SCS). The electrode will serve as a voltage reader deep in the tissue. The voltage is generated from electrodes applied on the skin and delivers therapeutic currents to the patients back. The study will be tested 4 different types of currents and number of electrode placement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation | – | Device: Transcutaneous Electric Nerve StimulationPatients who underwent implantation of electrodes spine for treatment in chronic pain. 'Transcutaneous Electric Nerve Stimulation' and "Transcranial Direct Current Stimulation" (one after another) |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who undergo electrodes implantation in lumbar spine due to chronic pain. Thease patients arrives 7 days after implantation to the clinic for a procedure of removing the electrodes.
Key inclusion criteria (2 listed)
- Normal cognitive status.
- language comprehension (understanding and speaking)a way that allows voluntary cooperation in research and compliance with the testing.
Key exclusion criteria (3 listed)
- Pregnant women.
- neurological pathologies (such as -head injury) or other systemic diseases that affect the sensation (such as diabetes).
- Each participant which at any stage in research expresses his wish to resign.
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 |
|---|---|---|
| Transcutaneous Electric Nerve StimulationAlso: Transcranial Direct Current StimulationElectric currents: 'Transcutaneous Electric Nerve Stimulation' and Transcranial Direct Current Stimulation will be applied on the back of the patients in parallel to the implanted electrodes. Implanted electrode will measure voltages that generated near the spinal cord tissue. | Device | Spinal Cord Stimulation |
Primary outcome
The amount of electric voltage
Time frame: monitoring voltage takes a few minutes only. Reading Voltage immidiatly- one test only for each current
The amount of electric voltage generated by different types of currents and different electrodes locations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Moty Mr Ratmansky, MD study chair
Site Sub-Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Sheba 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 2 inclusion and 3 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 28 Apr 2017. 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?
Results are not available in the source record.
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?
The amount of electric voltage (time frame: monitoring voltage takes a few minutes only. Reading Voltage immidiatly- one test only for each current). 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 Apr 2017.