UMIN-CTR Clinical Trial

Basic information
Public title	Immediate Effect of acupuncture on sensitized tissue in patients with chronic low back pain.
Acronym	Immediate Effect of acupuncture on sensitized tissue.
Scientific Title	Immediate Effect of acupuncture on sensitized tissue in patients with chronic low back pain.
Scientific Title:Acronym	Immediate Effect of acupuncture on sensitized tissue.
Region	Japan

Condition
Condition	chronic low back pain
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of the immediate effect of acupuncture on sensitized tissues in patients with low back pain
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Pressure pain threshold
Key secondary outcomes	Pressure pain rating Temporal summation Visual Analog Scale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Deep acupuncture
Interventions/Control_2	Shallow acupuncture
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) chronic low back pain lasting 3 month or more 2) Patients with localized pressure pain on lumbar part
Key exclusion criteria	1) Patients with lower numbness pain, numbness, weakness 2) Patients who had operation for lumbar spine in the past. 3) Patients who were determined by their doctors or head researchers to be inappropriate for research subjects for other reasons.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yoji Middle name Last name Kitagawa
Organization	Kansai University of Health Sciences
Division name	Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences
Zip code	5900482
Address	2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan
TEL	072-453-8251
Email	kitagawa@kansai.ac.jp

Public contact
Name of contact person	1st name Yoji Middle name Last name Kitagawa
Organization	Kansai University of Health Sciences
Division name	Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences
Zip code	5900482
Address	2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan
TEL	072-453-8251
Homepage URL
Email	kitagawa@kansai.ac.jp

Sponsor
Institute	Kansai University of Health Sciences
Institute
Department

Funding Source
Organization	Kansai University of Health Sciences
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kansai University of Health Sciences
Address	2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan
Tel	072-453-8251
Email	k.kimura@kansai.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	20
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

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 10 Month 21 Day
Date of IRB	2020 Year 10 Month 21 Day
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 11 Month 27 Day
Last modified on	2022 Year 05 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048593