Compared conventional and new stimulation methods for intractable neuropathic pain

JRCT ID: jRCT1042220094

Registered date:21/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neuropathic pain
• Date of first enrollment: 20/02/2023
• Target sample size: 92
• Study type: Interventional

Intervention(s)

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 more effective than conventional stimulation.
First step, cylinder-type electrodes are inserted under local anesthesia. Then, SCS trial is performed for 9 days and assessments of efficacy of conventional, DTM, or FAST stimulations. In the SCS trial, three stimulation methods are randomly assigned. Each stimulation method is performed under the condition that there is no information about which stimulation are being given. Enter stimulation off period about 24 hours between each stimulation method. Its purpose is to washout the effect of the stimulation method used before.
In cases of any stimulation methods is effective of SCS trial, proceed to the second step. Second step, cylinder-type electrodes are placed at the same site again and an implantable pulse generator is implanted under general anesthesia. Then, the effect of SCS is assessed at 1, 3, 6, 12, 18, and 24 months after the implantation surgery.

Outcome(s)

• Primary Outcome: 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 Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Saito Ryuta