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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02384785
• Other study ID #: SHEBA-12-9941-IGA-CTIL
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 24, 2015
• Last updated: April 26, 2017
• Start date: May 2013
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of electric voltage	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