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

NCT02384785 | Unknown

• 1 other identifier: SHEBA-12-9941-IGA-CTIL
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Transcutaneous Electric Nerve Stimulation 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.

Also known as: Transcranial Direct Current Stimulation

Spinal Cord Stimulation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Moty Mr Ratmansky, MD

  Site Sub-Investigator

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 10, 2015
• Study Start: May 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 28, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)