UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058513 |
|---|---|
| Receipt number | R000059681 |
| Scientific Title | Investigation of adapting transcutanoues electrical nerve stimulation using quantitative sensory testing on movement-evoked pain |
| Date of disclosure of the study information | 2025/07/18 |
| Last modified on | 2026/07/29 10:57:17 |
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Basic information
Public title
Investigation of adapting transcutanoues electrical nerve stimulation using quantitative sensory testing on movement-evoked pain
Acronym
Investigation of adapting transcutanoues electrical nerve stimulation on movement-evoked pain
Scientific Title
Investigation of adapting transcutanoues electrical nerve stimulation using quantitative sensory testing on movement-evoked pain
Scientific Title:Acronym
Investigation of adapting transcutanoues electrical nerve stimulation on movement-evoked pain
Region
| Japan |
Condition
Condition
patients with movement-evoked pain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the adapting transcutaneous electrical nerve stimulation on movement-evoked pain at pain phenotypes using quantitative sensory testing
To assess the impact of transcutaneous electrical nerve stimulation using quantitative sensory testing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain intensity (Numerical rating scale)
Quantitative sensory testing
Key secondary outcomes
resting pain
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Low frequency-transcutaneous electrical nerve stimulation
Interventions/Control_2
High frequency-transcutaneous electrical nerve stimulation
Interventions/Control_3
placebo transcutaneous electrical nerve stimulation
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
a
Key exclusion criteria
a
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Takiguchi |
Organization
Kio-University
Division name
Department of Physical Therapy , Faculty of Health Sciences
Zip code
635-0832
Address
Umaminaka, Koryocho, Kitakatsuragigun, Nara 635-0832, Japan.
TEL
+81-745-54-1601
n.takiguchi@kio.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Takiguchi |
Organization
Kio-University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
635-0832
Address
Umaminaka, Koryocho, Kitakatsuragigun, Nara 635-0832, Japan.
TEL
+81-745-54-1601
Homepage URL
n.takiguchi@kio.ac.jp
Sponsor or person
Institute
Kio university
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Kio university
Address
Umaminaka, Koryocho, Kitakatsuragigun, Nara 635-0832, Japan.
Tel
+81-745-54-1601
soumu@kio.ac.
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
学研都市病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000059681
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000059681
Number of participants that the trial has enrolled
8
Results
HF-TENS significantly reduced MEP compared to placebo TENS at 20 minutes (p=0.014).
Results date posted
| 2026 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Setting: Gakkentoshi Hospital outpatient
Study period: January-October 2025
Age: 18-60 years
Inclusion criteria: Shoulder disorder diagnosed >=3 months prior, TENS-naive
Exclusion criteria: Cardiac pacemaker, tumor, diabetes mellitus, peripheral vascular disease, local skin infection, motor paralysis, history of upper extremity surgery, upper-extremity conditions other than shoulder disorders
Participant flow
Written informed consent obtained
Baseline assessment
Randomization computer-generated random sequence
High-frequency TENS
Low-frequency TENS
Placebo TENS
Washout period
Assessment time points baseline, 20 min, after TENS
Adverse events
Nothing
Outcome measures
Movement-evoked pain (MEP)
Pressure pain threshold (PPT)
Pinprick pain intensity
Resting pain
Heart rate variability (HRV)
Reproducibility of shoulder elevation angle
Waveform correlation coefficient
Mean absolute angular difference
Waveform root mean square error (RMSE)
Reproduction rate
Intraclass correlation coefficient (ICC)
Standard error of measurement (SEM)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 18 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059681
