臨床研究等提出・公開システム

Date of registration	Oct. 03, 2024
Last modified on	June. 20, 2025
Trial ID	jRCT2042240094

Scientific Title	Exploratory trial of NP037 in patients with chronic pain
Public Title	Exploratory trial of NP037 in patients with chronic pain

Contact for Scientific Queries	Name	Horiuchi Yuto
	Affiliation	NIPRO CORPORATION
	Address	3023, Nojicho, Kusatsu, Shiga
	Telephone	+81-77-564-9467
	E-mail	horiuchi-yuto@nipro.co.jp
Contact for Public Queries	Name	Horiuchi Yuto
	Affiliation	NIPRO CORPORATION
	Address	3023, Nojicho, Kusatsu, Shiga
	Telephone	+81-77-564-9467
	E-mail	horiuchi-yuto@nipro.co.jp

Recruitment status	Not Recruiting


Anticipated date of first enrollment		Nov. 01, 2024
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients who are 20 years of age or older at the time of consent with consent obtained from the patient. 2. Patients with chronic pain and the pain site is in the shoulder or lower back. etc.
	Exclusion Criteria	1. Patients who are pregnant or have just given birth 2. patients who have difficulty setting up the probes of the investigational device 3. Patients who cannot answer the test correctly etc.
	Age Minimum	20age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		chronic pain
Intervention(s)		The probe of the test or control device is applied to the pain site for treatment.
Primary Outcome(s)		Change in VAS on Day 0 (before use) and on Day 28 (after use)

Primary Sponsor	NIPRO CORPORATION

Secondary Sponsor

Name of Certified Review Board	Nagoya City University Institutional Review Board
Address	1 Aza Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Aichi
Telephone	+81-52-851-5511
E-Mail	clinical_research@med.nagoya-cu.ac.jp
Approval Status	Not approval

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	June. 20, 2025	(this page)	Changes
2	Feb. 18, 2025	Detail	Changes
1	Oct. 03, 2024	Detail

List of change history