UMIN-CTR Clinical Trial

Basic information
Public title	Effects of acupuncture on sensory symptome and motor signs in patients with Restless Legs Syndrome
Acronym	RLS and Acupuncture
Scientific Title	Effects of acupuncture on sensory symptome and motor signs in patients with Restless Legs Syndrome
Scientific Title:Acronym	RLS and Acupuncture
Region	Japan

Condition
Condition	Restless Legs Syndrome
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the effects of acupuncture on sleep disturbances in patients with RLS
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Scores of lower limb discomfort and scores of PLMs measured by SIT(Suggested Immobilization Test)
Key secondary outcomes	Scores measured by the insomnia severity questionnaire.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Acuinjection of normal saline (about 0.1- 0.25 ml in dose) at four acupoints (GB41, BL60, ST36, and SP6) in both legs.
Interventions/Control_2	Injection of normal saline (about 0.1-0.25 ml in dose) at four non-acupoint areas in both legs.
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	20 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who meets diagnostic criterias of RLS
Key exclusion criteria	Patients who meet one of the following criterias are excluded. 1:Patients with severe neurologtical diseases. 2:Patients with severe major organ disdeases except renal failure. 3:Patients with dementia. 4:Patients with severe sleep disease other than RLS 5:Patients with some significant disease which influence acupuncture treatment. 6:Patients whose docter in chage do not agree to join this study.
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takero Fukutome
Organization	Fukuoka Sleep Clinic
Division name	Director
Zip code
Address	Chambord Daimyo B1301, Daimyo 2-10-2, Tyuou-Ku, Fukuoka City
TEL	092-400-2007
Email	fukuoka_suimin@aurora.ocn.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Takero Fukutome
Organization	Fukuoka Sleep Clinic
Division name	Director
Zip code
Address	Chambord Daimyo B1301, Daimyo 2-10-2, Tyuou-Ku, Fukuoka City
TEL	092-400-2007
Homepage URL	http://www.fukuoka-suimin.org
Email	fukuoka_suimin@aurora.ocn.ne.jp

Sponsor
Institute	Fukuoka Sleep Clinic
Institute
Department

Funding Source
Organization	Fukuoka Sleep Clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	550
Org. issuing International ID_1	JCHO Kyusyu Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	ふくおか睡眠クリニック

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 20 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	8
Results	1:The Mean Discomfort Score in the Verum group-acupoint injection group- was significantly decreased than in the Sham group 2:There were no statistically significant differences in mean PLMI between the groups
Results date posted	2022 Year 01 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Mean age was 62.7 years and mean International mean Restless Legs Syndrome Study Group rating scale was 22.6.
Participant flow	There were a total of 53 subject applications in this study, and 8 subjects were enrolled.
Adverse events	None
Outcome measures	Leg discomfort and PLM
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 10 Day
Date of IRB	2017 Year 01 Month 23 Day
Anticipated trial start date	2017 Year 01 Month 23 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 12 Month 31 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 01 Month 15 Day
Last modified on	2022 Year 01 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035149