Examination of the optimal timing of temporary Spinal Cord Stimulation for herpes zoster-associated pain in the subacute phase: Multiinstitutional prospective observational study

UMIN ID: UMIN000050704

Registered date:03/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Zoster-Associated Pain
• Date of first enrollment: 2023/04/03
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: The reduction rate of VAS value between before and after tSCS treatment. If a decrease in VAS value more than 50% is observed, it has a therapeutic effect (EF), and if a decrease in VAS value less than 50% is observed, the treatment effect is poor (NE) . The optimal timing of treatment is determined by divided into two groups; Early Treatment group (ET) , Late Treatment group (LT), depending on the time of start of treatment. We examine the time when the Odd ratio between the EF group and the NE group is maximum.
• Secondary Outcome: We examine the efficiency of the VAS value less than 20mm, HADS and PCS before and after tSCS treatment. We plan to examine changes in EQ-5D levels, analyze factors related to patient information and treatment effect, including spinal MRI findings, and analyze the number of complications associated with tSCS treatment.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: (1) Women who are pregnant or may become pregnant (2) Patients whose pain disorder other than ZAP is judged by the principal investigator or co-investigator to affect the evaluation of pain for ZAP (3) Other patients who the Principal Investigator or Co-Investigator deems inappropriate as research subjects.

Related Information

• Primary Sponsor: Okayama University
• Source(s) of Monetary Support: private fund