Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lowe… (NCT03543085) | Clinical Trial Compass
CompletedNot Applicable
Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain
Taiwan10 participantsStarted 2018-04-12
Plain-language summary
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.
Who can participate
Age range20 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age ≧20 and ≦75
✓. 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.
✓. Have an average pain score \>5 by Visual Analogue Scale (VAS) on inclusion.
✓. Has failed to achieve adequate pain relief from prior pharmacologic treatments.
✓. In the judgement of the investigator, the subject is an appropriate candidate for the trial procedure.
✓. The subject is willing and able to comply with the procedure and requirements of this trial.
✓. 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
✕. 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.
✕. Subject has exhibited unstable pain condition within the past 30 days as interviewed by Investigator.
✕. 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).
What they're measuring
1
Change in Visual Analog Score From Baseline to Day 14
✕. Has had corticosteroid therapy at an intended site of stimulation within the past 30 days.
✕. Pain medication(s) dosages(s) are not stable for at least 30 days at investigator's discretion.
✕. 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.
✕. Have a current diagnosis of cancer with active symptoms.
✕. Have a known terminal illness with life expectancy less than one year.