UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030807 |
|---|---|
| Receipt number | R000035149 |
| Scientific Title | Effects of acupuncture on sensory symptome and motor signs in patients with Restless Legs Syndrome |
| Date of disclosure of the study information | 2018/01/20 |
| Last modified on | 2022/01/14 10:03:18 |
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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
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
fukuoka_suimin@aurora.ocn.ne.jp
Sponsor or person
Institute
Fukuoka Sleep Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035149
| Research Plan | |
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| Registered date | File name |
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