Effectiveness of of Therapeutic Currents in Clinical Dimension and Penetration Depth Dimension in Lower Back

April 26, 2017 updated by: Sheba Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Hashomer, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Normal cognitive status.
  • language comprehension (understanding and speaking)a way that allows voluntary cooperation in research and compliance with the testing.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Device: Transcutaneous Electric Nerve 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.
Other Names:
  • Transcranial Direct Current Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
monitoring voltage takes a few minutes only. Reading Voltage immidiatly- one test only for each current

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Study Chair: Moty Mr Ratmansky, MD, Site Sub-Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • SHEBA-12-9941-IGA-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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