臨床研究等提出・公開システム

Date of registration	Oct. 29, 2021
Last modified on	Nov. 24, 2021
Trial ID	jRCT1020210044

Scientific Title	Development of a questionnaire to evaluate the risk of chronic postsurgical pain
Public Title	Development of a questionnaire to evaluate the risk of chronic postsurgical pain

Contact for Scientific Queries	Name	NAKANO YUKO
	Affiliation	Fukushima Medical University
	Address	1 Hikariga-oka, Fukushima City, Fukushima Pref, JAPAN
	Telephone	+81-245471324
	E-mail	yamayu09@fmu.ac.jp
Contact for Public Queries	Name	NAKANO YUKO
	Affiliation	Fukushima Medical University
	Address	1 Hikariga-oka, Fukushima City, Fukushima Pref, JAPAN
	Telephone	+81-24-547-1324
	E-mail	yamayu09@fmu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 29, 2021
Actual date of first enrollment		Nov. 02, 2021
Target sample size		800
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Spine Outpatients with chronic pain who have consented to participate in the study in Fukushima Medical University.
	Exclusion Criteria	Those under the age of 20, those who do not understand the research protocol due to mental illness or dementia, those who cannot tolerate pressure stimulation or who have skin damage at the stimulation site are excluded.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chronic Pain
Health Condition(s) Keyword		Diagnosis
Health Condition(s) Code		D059350
Primary Outcome(s)		Relationship between pain at 6 months after surgery and preoperative pain-related evaluation scale and CPM value.
Secondary Outcome(s)		(Secondary endpoint 1) Relationship between pain-related evaluation scale and CPM value. (Secondary endpoint 2) Relationship between postoperative acute pain and preoperative pain-related evaluation scale and CPM value in patients who underwent spinal surgery.

Primary Sponsor	Fukushima Medical University Hospital

Name of Certified Review Board	Fukushima Medical University Ethics Review Board
Address	1 Hikariga-oka, Fukushima City, Fukushima Pref, Japan, Fukushima
Telephone	+81-24-547-1825
E-Mail	fmucrb@fmu.ac.jp
Approval Status	Approval
Date of approval	Oct. 01, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Nov. 24, 2021	(this page)	Changes
1	Oct. 29, 2021	Detail

List of change history