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

• Conditions: Pain
• Interventions: Device: Transcutaneous Electric Nerve Stimulation

• Registration Number: NCT02384785
• Lead Sponsor: Sheba Medical Center

Brief 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. 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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-10
• Status Verified: 2016-10
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulation	Transcutaneous Electric Nerve 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)

Primary Outcome Measures

Name	Time	Method
The amount of electric voltage	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

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel