UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of press needles for self-care in chronic neck pain: a randomized, placebo-controlled trial
Acronym	Effectiveness of press needles for self-care in chronic neck pain: a randomized, placebo-controlled trial
Scientific Title	Effectiveness of press needles for self-care in chronic neck pain: a randomized, placebo-controlled trial
Scientific Title:Acronym	Effectiveness of press needles for self-care in chronic neck pain: a randomized, placebo-controlled trial
Region	Japan

Condition
Condition	chronic neck pain
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of self-care for chronic neck pain with applying press needles once a week for three weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	neck pain intensity using a 100 mm visual analogue scale (VAS) is assessed at baseline (A0), one week after the first intervention (A1), after finishing intervention (A2), and one week follow up (A3).
Key secondary outcomes	Motion-related neck pain (VAS) / Pressure pain threshold (PPT) / The Japanese version of the neck disability index (J-NDI) are assessed at baseline (A0), one week after the first intervention (A1), after finishing intervention (A2), and one week follow up (A3).

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	1. press needles Sessions are conducted once a week for three weeks. The intervention is applying press needles (0.15*0.6 mm needle bonded to a medical tape) on tender points for 7 days.
Interventions/Control_2	2. placebo Sessions are conducted once a week for three weeks. The intervention is applying placebo press needles (identical to the press needle, except the needle element had been removed) on tender points for 7 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	18 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	presented with neck pain, stiffness or tenderness at least 3 months
Key exclusion criteria	neuropathic or traumatic neck pain / under analgesic, muscle relaxant or antidepressant medication 1 week before the study commence / having acupuncture treatment, massage or physiotherapy within 2 weeks prior to this study
Target sample size	64

Research contact person
Name of lead principal investigator	1st name Yoshiyuki Middle name Last name Kawano
Organization	University of Tsukuba
Division name	Faculty of Human Sciences
Zip code	305-8577
Address	1-1-1 Tenno-dai, Tukuba, Ibaraki
TEL	029-853-8504
Email	kyoshiyuki@human.tsukuba.ac.jp

Public contact
Name of contact person	1st name Kaori Middle name Last name Horike
Organization	University of Tsukuba
Division name	master's program in rehabilitation science, graduate school of comprehensive human sciences
Zip code	112-0012
Address	3-29-1 Otsuka Bunkyo Tokyo
TEL	03-3942-6860
Homepage URL
Email	s2040269@s.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba master's program in rehabilitation science, graduate school of comprehensive human sciences
Institute
Department

Funding Source
Organization	University of Tsukuba
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	University of Tsukuba
Address	3-29-1 Otsuka Bunkyo Tokyo
Tel	03-3942-6860
Email	s2040269@s.tsukuba.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	2021 Year 04 Month 30 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
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	Preinitiation
Date of protocol fixation	2021 Year 04 Month 28 Day
Date of IRB	2021 Year 04 Month 28 Day
Anticipated trial start date	2021 Year 05 Month 15 Day
Last follow-up date	2021 Year 10 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	2021 Year 04 Month 30 Day
Last modified on	2021 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050294