臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 06, 2020
Last modified on	Feb. 03, 2025
Trial ID	jRCTs031190172

Scientific Title	Studies on pain control in musculoskeletal chronic pain diseases.
Public Title	Studies on pain control in musculoskeletal chronic pain diseases.

Contact for Scientific Queries	Name	Kamiyama Masataka
	Affiliation	Gunma University Hospital
	Address	3-39-22, Showa, Maebashi, Gunma
	Telephone	+81-27-220-8269
	E-mail	m-kamiyama@gunma-u.ac.jp
Contact for Public Queries	Name	Kamiyama Masataka
	Affiliation	Gunma University Hospital
	Address	3-39-22, Showa, Maebashi, Gunma
	Telephone	+81-27-220-8269
	E-mail	m-kamiyama@gunma-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 06, 2020
Actual date of first enrollment
Target sample size		240
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	The patients who were diagnosed with cervical spondylotic myelopathy, Lumbar disc herniation, Lumber spinal canal stenosis, Carpal tunnel syndrome, Osteoarthritis od the hip, Osteoarthritis of the knee or Chronic low back pain and his symptoms continue more than three months. The patients who have not received medication for neurological disease with the exception of Cervical spondylotic myelopathy, Lumbar disc herniation, Lumber spinal canal stenosis, Carpal tunnel syndrome, Osteoarthritis od the hip, Osteoarthritis of the knee or Chronic low back pain and his symptoms continue more than three months. The patients who have not received medication for a mental disorder. The patients who have written consent to participate in this study.
	Exclusion Criteria	The patients who were diagnosed with two or more in cervical spondylotic myelopathy, Lumbar disc herniation, Lumber spinal canal stenosis, Carpal tunnel syndrome, Osteoarthritis od the hip, Osteoarthritis of the knee or Chronic low back pain and his symptoms continue more than three months. The patient who should not be administered such drugs. The patient who should not take an MRI. The patient who has renal dysfunction (creatinine clearance >60mL/min) The patient who is considered by a doctor not to participate in this study.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cervical spondylotic myelopathy, Lumbar disc herniation, Lumber spinal canal stenosis, Carpal tunnel
Intervention(s)		To administer pregabalin, mirogabalin or duloxetine hfor 5 weeks.
Health Condition(s) Keyword		Cervical spondylotic myelopathy, Lumbar disc herniation, Lumber spinal canal stenosis, Carpal tunnel syndrome, Osteoarthritis od the hip, Osteoarthritis of the knee, Chronic low back pain.
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Assessment of CNS activity
Secondary Outcome(s)		Assessment of pain, psychology, QOL, and function.

Primary Sponsor

Primary Sponsor

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Gunma University Hospital Clinical Research Review Board
Address	3-39-15, Showa, Maebashi, Gunma, Gunma
Telephone	+81-27-220-8740
E-Mail	irb-jimukk-ciru@ml.gunma-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 04, 2019

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Feb. 03, 2025	(this page)	Changes
1	Jan. 06, 2020	Detail

List of change history