UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015574 |
|---|---|
| Receipt number | R000018096 |
| Scientific Title | Efficacy of acupuncture therapy on oversensitiveness to cold in adult females -a multicenter prospective randomized controlled trial |
| Date of disclosure of the study information | 2014/11/05 |
| Last modified on | 2025/11/01 11:49:27 |
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Basic information
Public title
Efficacy of acupuncture therapy on oversensitiveness to cold in adult females -a multicenter prospective randomized controlled trial
Acronym
Efficacy of acupuncture therapy on oversensitiveness to cold in females - randomized controlled trial
Scientific Title
Efficacy of acupuncture therapy on oversensitiveness to cold in adult females -a multicenter prospective randomized controlled trial
Scientific Title:Acronym
Efficacy of acupuncture therapy on oversensitiveness to cold in females - randomized controlled trial
Region
| Japan |
Condition
Condition
oversensitiveness to cold
Classification by specialty
| Medicine in general | Cardiology | Psychosomatic Internal Medicine |
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the efficacy of acupuncture therapy on oversensitiveness to cold in adult females by a multicenter prospective randomized controlled trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Variation of degree of hie on average visual analogue scale between before one week start of intervention and the second week start of intervention, after finish of intervention
Key secondary outcomes
Changes in eight heading score and two component summary of SF-36v2 Standard Edition before and after the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Needle retention to SP6 and electro-acupuncture therapy to BL32 at a frequency of 1Hz for 20min. for 4 sessions, with 1 session each other
Interventions/Control_2
No session(waiting list control)
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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
Adult females with oversensitiveness to cold and more than four point of total score in the" hiesho sensation scale"
Key exclusion criteria
1)pregnant or nursing
2)diabetes mellitus complicated by peripheral neuropathy
3)arteriosclerosis obliterans
4)Buerger's disease
5)connective tissue disease
6)hypothyroidism
7)hyperthyroidism
8)Patients medicated with following drugs every day: Chinese herbal medicine, alpha blocker, beta blocker, alpha and blocker, calcium antagonist and prostaglandinE1
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shunji |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kansai University of Health Sciences
Division name
Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences
Zip code
590-0482
Address
2-11-1 Wakaba, Kumatori, Sennan, Osaka, 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
Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences
Zip code
590-0482
Address
2-11-1 Wakaba, Kumatori, Sennan, Osaka, 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
Self funding
Nationality of Funding Organization
JAPAN
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-cho, Sennan-gun, Osaka, Japan
Tel
0724538409
sakaguti@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
| 2014 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Unpublished
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
100
Results
Both groups improved in cold hands and feet and six related VAS symptoms. For "general fatigue," median changes were -10.6 (Thermal Acupoint LW) vs -0.2 (Control LW), with a significant between-group difference (U = 1383.5, P = 0.04, r = 0.22). No other VAS symptoms differed. In the 15-symptom questionnaire, many symptoms improved; "easily fatigued" improved more in Control LW (3.0 vs 0.0, U = 767.5, P = 0.01, r = 0.27), but clinical relevance was limited. Other symptoms showed no significant differences.
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 groups in age (Thermal Acupoint LW group: 32.0 (4.6) years, Control LW group: 30.7 (5.1) years, P = 0.19) or BMI (Thermal Acupoint LW group: 19.0 (2.4) kg/m2, Control LW group: 19.5 (2.7) kg/m2, P = 0.39).
Participant flow
A total of 100 participants were randomly assigned to either the Thermal Acupoint LW group (n = 50) or the Control LW group (n = 50). In the Thermal Acupoint LW group, 2 participants withdrew due to pregnancy, leaving 48 participants who completed the study and were included in the analysis. In the Control LW group, 4 participants were excluded due to missing or incomplete questionnaires, resulting in 46 participants included in the analysis.
Adverse events
During the intervention period, no adverse events were reported through the designated contact window. However, in the open-ended section of the blinded questionnaire, one participant in the Thermal Acupoint LW group reported a prickling sensation that was uncomfortable. As there was no direct inquiry from the participant, no interruption of the intervention was implemented. No other serious adverse events related to wearing the LW were observed.
Outcome measures
The primary outcomes were the severity of cold sensation in the hands and feet, as well as six symptoms reported to be associated with coldness ("dry mouth," "lower limb edema," "hot flashes," "hot flashes with coldness," "shoulder stiffness," and "general fatigue") [10], which were assessed using a 100-mm horizontal Visual Analogue Scale (VAS). Participants recorded their symptoms retrospectively each day before bedtime during the week preceding and following the 3-week intervention period. VAS scores for cold hands and feet and the six associated symptoms (measured as the distance in mm from the left end of the scale) were obtained, and the mean values over each one-week period were calculated.
Secondary outcomes were assessed using the symptom questionnaire developed by Uematsu and Manabe [11]. This questionnaire evaluates 15 symptoms ("fatigue," "general malaise," "nocturia," "low back pain," "irritability," "difficulty sleeping," "depressed mood," "warmth in hands and feet," "hot flashes with coldness," "cold lower limbs," "lower limb edema," "shoulder stiffness," "dry skin," "gas accumulation in the gastrointestinal tract [frequent passage of gas]") in terms of both frequency (1 = never, 2 = rarely, 3 = sometimes, 4 = often) and severity (1 = not at all bothersome, 2 = slightly bothersome, 3 = moderately bothersome, 4 = very bothersome). Participants completed the questionnaire retrospectively for the month preceding the first day of the intervention and the month following the last day of the intervention. For each symptom, a score was calculated by multiplying frequency and severity, yielding a possible range of 1-16 points per symptom.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 22 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 25 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 31 | 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=R000018096
