Neuropathic pain following a spinal cord lesion
Conditions
Interventions
In order to evaluate the research hypotheses that spinal cord stimulation (SCS) using new stimulation method of differential target multiplexed (DTM) stimulation via a paddle lead placing at the rostr
Sponsors
Saito Ryuta
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with intractable neuropathic pain following spinal cord lesion resistance to medication treatments -18 years of age or older -Pain scale of VAS (Visual analog scale) is more than 4 point -Patients who classified as Frankel grade: B-E -Patients in whom a paddle-shaped lead can be placed on the rostral side of the spinal cord lesion -Patients who have obtained written consent from the patient
Exclusion criteria
Exclusion criteria: -Patients for whom local and general anesthesia cannot be performed -Patients who classified as Frankel grade A -Patients receiving anti-cancer therapy -Patients with a history of drug abuse -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 |
|---|---|
| Evaluate of effective rates of the new methods at the time of 3 months after the implantation surgery compared with preoperative. Effective is defined as achieving more than 33% for pain improvement by VAS. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Assessments of effect of SCS trial. 2) Evaluation of changes in pain scale: VAS, SF-MPQ-2 (Short-Form McGill Pain Questionnaire-2), mental score: PCS (Pain Catastrophizing Scale), Simple Depressive Symptom Scale, and comprehensive health: SF-36 (MOS Short-Form 36-Item Health Survey) at 1, 3, 6, 12, 18 months, and at the time of final follow-up (24 months) from spinal cord stimulation system implantation. 3) Examination of the relationship between the presence or absence of SCS trial and the effect of pain relief after spinal cord stimulation system implantation. 4) Defines long-term effects as that continue for more than 12 months, and detects factors associated with long-term effects. 5) Evaluation whether there is improvement of motor function using the gait function scale: FAC (Functional Ambulation Categories) at 1, 3, 6, 12, 18 months, and at final follow-up (24 months) from spinal cord stimulator implantation. 6) Extraction of diseases related to this study at 3 months after the implantation surgery. | — |
Contacts
Public ContactTakafumi Tanei
Nagoya University, Graduate School of Medicine
Outcome results
None listed