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A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain

CompletedNot applicableNCT03285113
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 pilot study to confirm the safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The actual trial length is 5 days. Pts will be given ultrahigh frequency pulse stimulation, and VAS will be obtained after 3-4 hours of each stimulation.

Study details

Official title
A Single-arm, Open Label, Single Center Pilot Study to Confirm the Safety of Dorsal Root Ganglia (DRG) and Ultrahigh Frequency Spinal Cord Stimulator in Patients With Chronic Lower Limb Pain
Conditions
Interventions
  • Device: GiMer Medical MN 1000 External Stimulator
Sponsor
GiMer Medical
Collaborators
China Medical University Hospital
Start date
2017-03-03
Primary completion
2018-02-05
Sex
All
Age range
from 20 Years to 75 Years
Healthy volunteers
true
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 complex regional pain syndrome (CRPS), failed back surgery syndrome (FBSS), lower limb pain with or without lower back pain with a diagnosis related to spinal lesion and 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 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 escalating or changing pain condition within the past 30 days as evidenced by Investigator examination. 3. Be on anticoagulant medication with 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. 6. Has previously failed spinal cord stimulation therapy. 7. Currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy. 8. Has pain only within a cervical or thoracic distribution. 9. Have a current diagnosis of cancer with active symptoms 10. Have a known terminal illness with life expectancy less than one year 11. Have a systematic or local infection 12. Currently has an indwelling device that may pose an increased risk of infection. 13. Be pregnant or breast feeding 14. Have a medical history of drug or alcohol addiction within the past 2 years. 15. Participation in any investigational study in the last 30 days or current enrollment in any trial. 16. Be currently involved in an injury claim law suit or medically related litigation, including workers…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03285113