UMIN-CTR Clinical Trial

Basic information
Public title	Is acupuncture really effective on neck/shoulder stiffness (chronic neck pain) ? A randomized double-blind placebo controlled clinical trial.
Acronym	IAREONSS (cnp) ARDBCT
Scientific Title	Effects of acupuncture on neck/shoulder stiffness (chonic neck pain) : A randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym	EAK (cnp) ARDBCT
Region	Japan

Condition
Condition	Musculoskeletal discomfort
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of acupuncture on neck/shoulder stiffness
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of neck/shoulder stiffness immediately and 24 hours after the treatment
Key secondary outcomes	Practitioners' and patients' guesses at the needle authenticity and their confidence on their guesses

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Treatment with penetrating needles
Interventions/Control_2	Treatment with press-skin placebo needles (the needle tip presses against the skin)
Interventions/Control_3	Treatment with skin-touch placebo needles (the needle tip presses against the skin)
Interventions/Control_4	Treatment with no-touch placebo needles (the needle tip does not reach the skin)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with neck/shoulder stiffness not from organic disease
Key exclusion criteria	1. Cervical spondylosis 2. Cervical disc herniation 3. Cervico-omo-brachial syndrome 4. Thoracic outlet syndrome 5. Liver, gallbladder or heart disease 6. High blood pressure 7. Cerebral vascular disease 8. Neurological disease 9. Under any pharmacological treatment 10. Patients who will receive any cure for neck/shoulder stiffness or acupuncture treatment within 24 hours after treatment in this study
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Nobuari Middle name Last name Takakura
Organization	Tokyo Ariake University of Medical and Health Science
Division name	Department of Acupuncture and Moxibustion
Zip code	135-0063
Address	2-9-1 Ariake Koto-ku, Tokyo, Japan
TEL	03-6703-7000
Email	takakura@tau.ac.jp

Public contact
Name of contact person	1st name Nobuari Middle name Last name Takakura
Organization	Tokyo Ariake University of Medical and Health Sciences
Division name	Department of Acupuncture and Moxibustion
Zip code	135-0063
Address	Ariake, Koto-ku, Tokyo, Japan
TEL	03-6703-7000
Homepage URL
Email	takakura@tau.ac.jp

Sponsor
Institute	Tokyo Ariake University of Medical and Health Sciences
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Ariake University of Medical and Health Sciences IRB
Address	2-9-1 Ariake, Koto-ku, Tokyo 135-0063, Japan
Tel	03-6703-7000 (+81-3-6703-7000)
Email	akiyama@tau.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 03 Month 20 Day

Related information
URL releasing protocol	None
Publication of results	Published

Result
URL related to results and publications	https://kaken.nii.ac.jp/ja/report/KAKENHI-PROJECT-16K09266/16K09266seika/
Number of participants that the trial has enrolled	160
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Pending approval from the journal to which you are submitting.
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	Main results already published
Date of protocol fixation	2015 Year 10 Month 01 Day
Date of IRB	2015 Year 12 Month 03 Day
Anticipated trial start date	2018 Year 04 Month 03 Day
Last follow-up date	2019 Year 10 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 03 Month 17 Day
Last modified on	2022 Year 04 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053827