UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048216 |
|---|---|
| Receipt number | R000054942 |
| Scientific Title | Self-Shiatsu Improves Sleep Quality in Individuals with Restless Legs Syndrome: An Exploratory Randomized Trial |
| Date of disclosure of the study information | 2022/07/03 |
| Last modified on | 2025/10/28 12:07:05 |
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Basic information
Public title
Self-Shiatsu Improves Sleep Quality in Individuals with Restless Legs Syndrome: An Exploratory Randomized Trial
Acronym
Self-shiatsu reduced WASO of RLS patients
Scientific Title
Self-Shiatsu Improves Sleep Quality in Individuals with Restless Legs Syndrome: An Exploratory Randomized Trial
Scientific Title:Acronym
Self-shiatsu reduced WASO of RLS patients
Region
| Japan |
Condition
Condition
Restless legs syndrome
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Estimate the effectiveness of self acupressure on symptoms of Restless Legs Syndrome and their sleep.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
IRLS (International Restless Legs Syndrome Study Group) rating scale
Key secondary outcomes
Pittsburgh sleep quality index
Insomnia severity index
Demographic data
Sleep diary
Actigraphy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients are instructed to perform self-acupressure on the lower extremities for 15 minutes daily between dinner and bedtime for 4 weeks.
Interventions/Control_2
Instructed to apply a sticker to a false meridian point on the lower extremity for 15 minutes daily between dinner and bedtime for 4 weeks.
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
1) Patients with restless legs syndrome or who meet the criteria in the screening test.
2) No obstacles to completing the survey.
3) The person agrees to participate in the research.
Key exclusion criteria
1) Have a serious medical condition other than restless legs.
2)Receiving manual therapy within one month.
3) Withdrawal of the consents to the participation of this study.
4) Change of prescription which may affect the outcome during the study period.
5) Patients who were assessed that they should not to be indicated self-acupressure therapy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hirokuni |
| Middle name | |
| Last name | Tagaya |
Organization
Kitasato University, School of Allied Health Science, Department of Health Science
Division name
Mental Health
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
+81-42-778-8031
tagaya@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Asami |
| Middle name | |
| Last name | Uozumi |
Organization
Kitasato University, Graduate School of Medical Science
Division name
Sleep Medicine
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
+81-42-778-8031
Homepage URL
rls.kenkyuu@gmail.com
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
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
Kitasato University, School of Allied Health Science,Institutional Review Board
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel
+81-42-778-9757
kenkyu@kitasato-u.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
北里大学(神奈川県)、睡眠総合ケアクリニック代々木(東京都)、太田睡眠科学センター(神奈川県)、北里大学病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 03 | 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
16
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
Suspended
Date of protocol fixation
| 2022 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054942
