Status:
TERMINATED
High-Density Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain Patients
Lead Sponsor:
Seoul National University
Conditions:
Pain, Intractable
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to explore which mode is effective in the management of intractable chronic pain, the high-density stimulation or the conventional stimulation, in patients who undergo SCS...
Detailed Description
Since its introduction in 1967 (1), spinal cord stimulation (SCS) has become a well-established modality for the treatment of chronic neuropathic back and leg pain, including postlaminectomy syndrome,...
Eligibility Criteria
Inclusion
- Patients with chronic intractable pain who meets the Korean SCS Reimbursement Guideline as follows:
- (Korea SCS Reimbursement Guideline)
- 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
- 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.
- Age \> 18
- Patients who have been informed of the study procedures and has given written informed consent.
- Patients who are willing to comply with study protocol including attending the study visits
Exclusion
- Expected inability of patients to receive or properly operate the SCS system
- Active malignancy
- Addiction to any of the following drugs, alcohol, and/or medication
- 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
- Local infection or other skin disorder at site of incision
- Pregnancy
- Other implanted active medical device
- Life expectancy \< 1 year
- Coagulation deficiency (Platelet count \< 100,000, PT INR \> 1.4)
- Immune deficiency (HIV positive, immunosuppressive, etc.)
Key Trial Info
Start Date :
July 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03318172
Start Date
July 14 2017
End Date
April 12 2018
Last Update
November 8 2022
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744