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

NCT ID: NCT02384785

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Transcutaneous Electric Nerve Stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Transcranial Direct Current Stimulation

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moty Mr Ratmansky, MD

Role: STUDY_CHAIR

Site Sub-Investigator

Locations

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Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-12-9941-IGA-CTIL

Identifier Type: -

Identifier Source: org_study_id

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