Neuropathic pain
Conditions
Interventions
In order to evaluate the research hypotheses that spinal cord stimulation (SCS) using new stimulation method of differential target multiplexed (DTM) or fast-acting sub-perception therapy (FAST) is mo
Sponsors
Saito Ryuta
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with intractable neuropathic pain resistance to medication treatments using more than two drugs -18 years of age or older -Pain scale of VAS (Visual analog scale) is more than 4 point -Patients who have obtained written consent from the patient
Exclusion criteria
Exclusion criteria: -Patients receiving anti-cancer therapy -Patients with a history of drug abuse -Patients with histories of spine or spinal cord surgery at the site through which the spinal cord stimulation electrode passes or will be placed -Patients for whom local and general anesthesia cannot be performed -Patients with high risk of surgery, such as patients with unstable angina pectoris and with end-stage liver disease presenting with hepatic encephalopathy -Patients with diabetes mellitus who are not well controlled (HbA1c 9% or more) -Patients with serious complications (liver disease, kidney disease, heart disease, lung disease, blood disease, brain disease, etc.) -Pregnant or potentially pregnant patients -Patients who are considered as inappropriate by a head of research or research assignations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective is defined as achieving more than 33% for pain improvement by VAS. Verify the new stimulus method (DTM or FAST stimulation) has higher rates of pain improvement than conventional stimulation at the end of the SCS trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Evaluate improvement rates of pain scale VAS for each stimulation methods by each causative disease at the SCS trial. 2 Comparison of improvement rates of DTM and FAST stimulation of pain scale VAS by all cases and causative diseases. 3 Assessments of changes of pain scales and psychiatric scores compared to preoperative and postoperative at 1, 3, 6, 12, 18 months, and final follow-up (24 months) from spinal cord stimulation implantation. 4 Long-term effect is defined as the effect (improvement of more than 33% by VAS before preoperative) is continued at postoperative 1, 3, 6, and 12 months. Assessments of the correlation with the long-term effect and related background factors. 5 Extraction of diseases related to this study 3 months after surgery. | — |
Contacts
Public ContactTakafumi Tanei
Nagoya University, Graduate School of Medicine
Outcome results
None listed