KCT0003814
Terminated
未知
High Density Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain Patients: A Prospective Multicenter Randomized Controlled, Double-blind, Crossover Exploratory Study with 6-m Open Follow-up
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Sponsor
- Seoul National University Hospital
- Enrollment
- 100
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\)Patients with chronic intractable pain who meets the Korean SCS Reimbursement Guideline as follows:
- •(Korea SCS Reimbursement Guideline)
- •a)An ineffective patient with sustainable severe intractable pain (VAS or NRS pain score over 7 grade) who has been treated by a conservative therapy (medication and nerve block, etc.) for 6 months.
- •cf.) CRPS is available after the conservative therapy for 3 months
- •b)An ineffective cancer pain patient with over 1 year life expectancy and VAS (or NRS pain score) over 7 grade who takes active pain treatment for 6 months such as medication, nerve block, epidural morphine injection, etc.
- •(2\)Age \> 18
- •(3\)Patients who have been informed of the study procedures and has given written informed consent.
- •(4\)Patients who are willing to comply with study protocol including attending the study visits
Exclusion Criteria
- •(1\)Expected inability of patients to receive or properly operate the SCS system
- •(2\)Active malignancy
- •(3\)Addiction to any of the following drugs, alcohol, and/or medication
- •(4\)Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- •(5\)Local infection or other skin disorder at site of incision
- •(6\)Pregnancy
- •(7\)Other implanted active medical device
- •(8\)Life expectancy \< 1 year
- •(9\)Coagulation deficiency (Platelet count \< 100,000, PT INR \> 1\.4\)
- •(10\)Immune deficiency (HIV positive, immunosuppressive, etc.)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
Spinal Cord Stimulation for intractable chronic lower abdominal neuropathic pain caused by endometriosisNL-OMON50815Academisch Medisch Centrum15
Terminated
Not Applicable
High-Density Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain PatientsPain, IntractableNCT03318172Seoul National University25
Completed
Phase 4
BurstDRTM Spinal Cord Stimulation for Refractory Angina Pectoris - a pilot studyRefractory Angina Pectoris10011082NL-OMON48309Diakonessenhuis Utrecht10
Recruiting
Not Applicable
BurstDRTM Spinal Cord Stimulation for Refractory Angina Pectoris - a pilot studyRefractory Angina PectorisNL-OMON28539Diakonessenhuis Utrecht/Zeist10
Recruiting
Not Applicable
Spinal cord stimulation for treating neuropathic pain after chemotherapy / radiotherapy; a pilot studyneuropathic pain caused by chemotherapy / radiotherapy10034606NL-OMON47554Medisch Spectrum Twente11