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High-Density Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain Patients

TerminatedNot applicableNCT03318172
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)

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 implantation after successful pre-implantation SCS trial.

Study details

Official title
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
Sponsor
Seoul National University
Start date
2017-07-14
Primary completion
2018-03-22
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
South Korea
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Patients with chronic intractable pain who meets the Korean SCS Reimbursement Guideline as follows: (Korea SCS Reimbursement Guideline) 1. 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 2. 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.)

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03318172