UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048741 |
|---|---|
| Receipt number | R000055531 |
| Scientific Title | Effects of auricular pressure stimulation and press tack needle stimulation of the abdomen and lower extrmities by self-care for simple obesity - a randomized controlled trial using auricular pressure stimulation as a control |
| Date of disclosure of the study information | 2022/08/24 |
| Last modified on | 2025/11/01 12:04:31 |
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Basic information
Public title
Effects of self-care with auricular pressure stimulation and press tack needle stimulation of the abdomen and lower limbs on simple obesity
Acronym
Effects of oriental medical self-care for simple obesity
Scientific Title
Effects of auricular pressure stimulation and press tack needle stimulation of the abdomen and lower extrmities by self-care for simple obesity - a randomized controlled trial using auricular pressure stimulation as a control
Scientific Title:Acronym
Effects of oriental medical self-care on simple obesity in a randomized controlled trial
Region
| Japan |
Condition
Condition
Simple obesity
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the combined effects of auricular pressure stimulation and press tack needle stimulation on the abdomen and lower limbs as self-care in a randomized controlled trial using auricular pressure stimulation alone as a control, with the aim of making it easier, safer and cheaper for simply obese people to lose weight.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight(Before intervention, 5 weeks after the start of the intervention and 3 weeks after the end of the intervention)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Lifestyle guidance (8 weeks) with auricular pressure stimulation and press tack needle stimulation of the abdomen and lower limbs (5 weeks)
Interventions/Control_2
Lifestyle guidance (8 weeks) with auricular pressure stimulation (5 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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
BMI above 25 or abdominal circumference above 85 cm in men and above 90 cm in women
Key exclusion criteria
Symptomatic obesity, diabetes mellitus currently under treatment
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Shunji |
| Middle name | |
| Last name | sakaguchi |
Organization
Kansai University of Health Sciences
Division name
Graduate school
Zip code
590-0482
Address
2-11-1 Wakaba, Kumatori, Sennan, Osaka, 590-0482, JAPAN
TEL
072-453-8409
sakaguti@kansai.ac.jp
Public contact
Name of contact person
| 1st name | Shunji |
| Middle name | |
| Last name | sakaguchi |
Organization
Kansai University of Health Sciences
Division name
Graduate school
Zip code
590-0482
Address
2-11-1 Wakaba, Kumatori, Sennan, Osaka, 590-0482, JAPAN
TEL
072-453-8409
Homepage URL
sakaguti@kansai.ac.jp
Sponsor or person
Institute
Kansai University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kansai University of Health Sciences
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
Kansai University of Health Sciences
Address
2-11-1 Wakaba, Kumatori, Sennan, Osaka, 590-0482, JAPAN
Tel
072-453-8251
k.kimura@kansai.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 | 08 | Month | 24 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
39
Results
No significant between-group differences were observed in changes in body weight or waist circumference (Body weight: Additional -1.58 vs Common -1.74, mean difference 0.17, P >= 0.05, 95% CI -1.21 to 1.55, d = 0.09; Waist: Additional -2.27 vs Common -2.13, mean difference 0.09, P >= 0.05, 95% CI -2.14 to 1.85, d = 0.05). In body composition, significant differences were found in body fat and water content, but not in muscle mass.
Results date posted
| 2025 | Year | 11 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No significant differences were observed between the two groups in baseline characteristics of the participants.
Participant flow
A total of 39 individuals applied, and 30 participants were block-randomized by sex and age. One participant in the Control group dropped out during the intervention; therefore, the analysis included 13 participants in the Additional group (8 men, 5 women; mean age 52.5 (13.6) years) and 16 participants in the Control group, excluding the dropout (8 men and 8 women; mean age 49.3 (13.7) years).
Adverse events
No adverse events were observed, such as negative effects on physical condition associated with auricular acupressure or skin itching caused by the application of ear-needle-like contact devices.
Outcome measures
Body weight, waist circumference, and body composition were measured before and after the 5-week intervention, as well as at the end of the observation period (3 weeks after the intervention). During the 3 weeks following the intervention, both groups received only lifestyle guidance.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 11 | 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 | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055531
