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Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain

CompletedNot applicableNCT03543085
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
A Single-arm, Open Label, Single Center, Prospective Study of Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain
Conditions
Interventions
  • Device: GiMer Medical MN 1000 External Stimulator
Sponsor
GiMer Medical
Collaborators
China Medical University Hospital
Start date
2018-04-12
Primary completion
2018-10-23
Sex
All
Age range
from 20 Years to 75 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Taiwan
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 a…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03543085