UMIN-CTR Clinical Trial

Basic information
Public title	Effect of different stimulation sites of the Press Needle on stiff neck and shoulder
Acronym	Effect of different stimulation sites of the Press Needle on stiff neck and shoulder
Scientific Title	Effect of different stimulation sites of the Press Needle on stiff neck and shoulder
Scientific Title:Acronym	Effect of different stimulation sites of the Press Needle on stiff neck and shoulder
Region	Japan

Condition
Condition	stiff neck and shoulder
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to examine the effect of Press Needle on stiff neck and shoulder.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual Analogue Scale immediately after intervention, 3 days after intervention
Key secondary outcomes	ROM of the neck Autonomic nerve measurement Questionnaire for stiff neck and shoulder. immediately after intervention, 3 days after intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	press needle on the neck for 3 days
Interventions/Control_2	press needle on the Upper limbs for 3 days
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	People with stiff shoulders
Key exclusion criteria	None
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Kondo
Organization	Tsukuba University of Technology
Division name	Faculty of Health Sciences
Zip code	305-8521
Address	Ibaraki, Tsukuba city, Kasuga 4-12-7
TEL	029-858-9559
Email	kondo0207@k.tsukuba-tech.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Kondo
Organization	Tsukuba University of Technology
Division name	Faculty of Health Sciences
Zip code	305-8521
Address	Ibaraki, Tsukuba city, Kasuga 4-12-7
TEL	029-858-9559
Homepage URL
Email	kondo0207@k.tsukuba-tech.ac.jp

Sponsor
Institute	Tsukuba University of Technology
Institute
Department

Funding Source
Organization	Tsukuba University of Technology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tsukuba University of Technology
Address	Ibaraki, Tsukuba city, Kasuga 4-12-7
Tel	029-858-9559
Email	kondo0207@k.tsukuba-tech.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	2022 Year 02 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	14
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 02 Month 20 Day
Date of IRB	2022 Year 02 Month 07 Day
Anticipated trial start date	2022 Year 02 Month 25 Day
Last follow-up date	2022 Year 05 Month 01 Day
Date of closure to data entry	2022 Year 05 Month 15 Day
Date trial data considered complete	2022 Year 05 Month 31 Day
Date analysis concluded	2022 Year 08 Month 26 Day

Other
Other related information

Management information
Registered date	2022 Year 02 Month 25 Day
Last modified on	2022 Year 08 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053516