Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain
Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain
This study is a prospective, single-arm, open label, single center to confirm the
 effectiveness and safety of an ultra-high frequency (500 KHz) spinal cord stimulation in
 patients with chronic back pain or lower limb pain.
This study is a prospective, single-arm, open label, single center to confirm the
 effectiveness and safety of an ultra-high frequency (500 KHz) spinal cord stimulation in
 patients with chronic back pain or lower limb pain. The trial length is 14 days. Patients
 will be given ultrahigh frequency pulse stimulation, up to 3 times in every 24 hours, and VAS
 will be obtained at least once a day. Compared to previous study conducted last year, patient
 can now have two lead implant sites for different pain locations. The electrode implantation
 site will be epidural space instead of Dorsal Root Ganglion (DRG).
Inclusion Criteria:

 1. Age ≧20 and ≦75

 2. Have a symptom of back or lower limb pain with a diagnosis related to spinal lesion,
 herniated disc, nerve injury, stenosis, failed back surgery syndrome (FBSS), complex
 regional pain syndrome (CRPS) or ischemic lower limb pain and have pain history of >6
 months.

 3. Have an average pain score >5 by Visual Analogue Scale (VAS) on inclusion.

 4. Has failed to achieve adequate pain relief from prior pharmacologic treatments.

 5. In the judgement of the investigator, the subject is an appropriate candidate for the
 trial procedure.

 6. The subject is willing and able to comply with the procedure and requirements of this
 trial.

 7. The participant is able to understand and provide informed consent, and has signed
 their written informed consent in accordance with Institutional Review Board (IRB)
 requirements.

 Exclusion Criteria:

 1. Have evidence of a mental or psychological condition that affects pain perception and
 has difficulty/disability performing objective pain assessment, or have previously
 failed mental or psychological assessments administered by a psychiatrist that may be
 deemed to indicate the subject's lack of suitability for participation in this study.

 2. Subject has exhibited unstable pain condition within the past 30 days as interviewed
 by Investigator.

 3. Be on anticoagulant medication with International Normalized Ratio (INR) >1.5 or
 platelet count less than 100,000/μL, peripheral vascular diseases (PVDs), visceral
 pain or uncontrolled Diabetes mellitus (DM).

 4. Has had corticosteroid therapy at an intended site of stimulation within the past 30
 days.

 5. Pain medication(s) dosages(s) are not stable for at least 30 days at investigator's
 discretion.

 6. Currently has an active implantable device including International Classification of
 Diseases (ICD), pacemaker, spinal cord stimulator or intrathecal drug pump or subject
 requires magnetic resonance imaging (MRIs) or diathermy.

 7. Have a current diagnosis of cancer with active symptoms.

 8. Have a known terminal illness with life expectancy less than one year.

 9. Have a systematic or local infection, which may increase study risk.

 10. Currently has an indwelling device that may pose an increased risk of infection.

 11. Be pregnant or breast feeding.

 12. Have a medical history of drug or alcohol addiction within the past 2 years.

 13. Participation in any investigational study in the last 30 days or current enrollment
 in any trial.

 14. Be currently involved in an injury claim law suit or medically related litigation,
 including workers compensation.

 15. Be a prisoner.