UMIN-ICDS Clinical Trial

Public title

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

Acronym

tSCS for subacute ZAP

Scientific Title

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

Scientific Title:Acronym

tSCS for subacute ZAP

Region

Japan

Condition

Zoster-Associated Pain

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose is to clarify the optimal timing of temporally Spinal Cord Stimulation for zoster-associated pain in the subacute phase.

Basic objectives2

Others

Basic objectives -Others

To clarify as factors that affect treatment prognosis, patient information, pain-related evaluation, spinal MRI findings, etc. will be examined.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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.

Key secondary outcomes

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

85

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Patients who visited the pain outpatient or pain clinic outpatient departments of each research institution among after approval by the ethics committee and 30 June 2025 are affected herpes zoster-associated pain (ZAP)
(2) Patients who have ZAP after the onset of herpes zoster between 1-6 months (30-180days)
(3) Patients who are affected the cervical or thoracic nerve region and have ZAP resistant to conservative treatment (VAS value more than 50mm)
(4) Patients as judged by the study director or co-investigator for tSCS treatment
(5) Patients who can voluntarily obtain written consent to participate in the study
(6) Patients whose age at the time of obtaining consent is more than 18 years old

Key exclusion 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.

Target sample size

60

Name of lead principal investigator

1st name	Kyosuke
Middle name
Last name	Arakawa

Organization

Okayama University Hospital

Division name

Department of Anesthesiology and Resuscitology

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama City

TEL

086-235-7330

Email

arakawa228@s.okayama-u.ac.jp

Name of contact person

1st name	Kyosuke
Middle name
Last name	Arakawa

Organization

Okayama University Hospital

Division name

Department of Anesthesiology and Resuscitology

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama City

TEL

086-235-7330

Homepage URL

Email

zap_scs_jimukyoku@okayama-u.ac.jp

Institute

Okayama University

Institute

Department

Personal name

Organization

private fund

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Okayama University Graduate School of Medicine, Dentistry, Pharmaceutical Sciences and Okayama University Hospital , Ethics committee

Address

2-5-1 Shikata-cho, Kita-ku, Okayama City

Tel

086-235-6938

Email

mae6605@adm.okayama-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

04

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

02

Month

20

Day

Date of IRB

2023

Year

03

Month

10

Day

Anticipated trial start date

2023

Year

04

Month

03

Day

Last follow-up date

2026

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Patient information is basic information such as age, gender, and affected nerve area, underlying diseases such as diabetes, immunodeficiency disease, and presence or absence of cancer-bearing patients. Treatment information are treatment results of drug treatment and nerve block treatment before and after tSCS treatment. Information of examinations are presence or absence of spinal cord MRI findings, physical findings such as the presence or absence of allodynia and decreased paresthesia. These information are collected from medical interviews and medical records.
Pain assessment uses VAS (Visual Analogue Scale) values at 5 points {enrollment (1), immediately after tSCS treatment (2), 2 weeks after treatment (3) , 1st month after treatment (4) and 3rd month after treatment (5)). Pain-related assessments are HADS (Hospital Anxiety and Depression Scale) and PCS (Pain Catastrophizing Scale) and EQ-5D (EuroQOL-5 Dimension) at the two points(at enrollment and at 3 months after treatment.
As the primary evaluation, the VAS value was 3 months after tSCS treatment (5) compared to (1) at the time of enrollment. We divide into two groups; EF (Effective) in cases with VAS more than 50% reduction and NE (Not Effective) in cases with VAS less than 50% reduction . 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.
As a secondary evaluation, we examine the efficiency of the VAS value less than 20mm, and HADS / 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.

Registered date

2023

Year

03

Month

28

Day

Last modified on

2024

Year

04

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057592