UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062732 |
|---|---|
| Receipt number | R000071828 |
| Scientific Title | intervention study on the effect of transcutaneous electrical nerve stimulation on acute pain on the second day after total knee arthroplasty |
| Date of disclosure of the study information | 2026/08/29 |
| Last modified on | 2026/08/29 08:51:45 |
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Basic information
Public title
intervention study on the effect of transcutaneous electrical nerve stimulation on acute pain on the second day after total knee arthroplasty
Acronym
intervention study on the effect of transcutaneous electrical nerve stimulation on acute pain on the second day after total knee arthroplasty
Scientific Title
intervention study on the effect of transcutaneous electrical nerve stimulation on acute pain on the second day after total knee arthroplasty
Scientific Title:Acronym
intervention study on the effect of transcutaneous electrical nerve stimulation on acute pain on the second day after total knee arthroplasty
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the factors associated with the efficacy of transcutaneous electrical nerve stimulation (TENS) for acute postoperative pain following total knee arthroplasty (TKA).
Basic objectives2
Others
Basic objectives -Others
Although transcutaneous electrical nerve stimulation (TENS) is widely utilized as a non-pharmacological intervention for acute postoperative pain management following total knee arthroplasty (TKA), individual pain relief responses vary substantially. The objective of this study is to investigate the patient-related characteristics and factors (e.g., preoperative pain characteristics, psychosocial factors, and quantitative sensory testing profiles) associated with the analgesic efficacy of TENS, thereby identifying potential predictors of responsiveness to TENS in this patient population.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in visual analog scale (VAS) score before and after transcutaneous electrical nerve stimulation (TENS)
Key secondary outcomes
PCS,TSK,PHQ-2,GAD-2,CSI-9,QST
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Standardized TENS intervention using a portable electrical stimulator (ITO ESPURGE, Ito Co., Ltd.). Four surface electrodes are placed 5 cm superior and inferior to the surgical incision on both medial and lateral sides. Stimulation parameters: frequency 2 100 Hz, pulse width 100 microseconds, and intensity adjusted to the maximum tolerable sensory threshold without muscle contraction or pain. Each session lasts 40 minutes and is administered during daily physical therapy sessions from postoperative day 2 to day 14. Standard postoperative physical therapy (e.g., range of motion exercises, muscle strengthening, and gait training) is provided concurrently as usual care.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with knee osteoarthritis undergoing primary total knee arthroplasty (TKA) Age 18 years or older Ability to read and write Capable of proper communication No prior history of TENS or opioid use preoperatively No history of chronic pain disorders, or alcohol/substance abuse Absence of an implanted cardiac pacemaker No neurological disorders Approved for TENS application by the attending surgeon/physician Written informed consent obtained from the patient
Key exclusion criteria
Presence of postoperative complications (e.g., surgical site infection, deep vein thrombosis) Hemodynamic instability Patients undergoing revision or secondary surgery postoperatively Patients who have prior knowledge or specific expectation of TENS analgesic efficacy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | KAZUKI |
| Middle name | |
| Last name | TANAKA |
Organization
Shimane University Hospital
Division name
Department of Rehabilitation
Zip code
6938501
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853202457
tanaka31@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | KAZUKI |
| Middle name | |
| Last name | TANAKA |
Organization
Shimane University Hospital
Division name
Department of Rehabilitation
Zip code
69388501
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853202457
Homepage URL
tanaka31@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Medical Research Ethics Committee, Faculty of Medicine, Shimane University
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
Tel
0853-20-2515
kenkyu@med.shimane-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 29 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 01 | 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
| 2026 | Year | 08 | Month | 29 | Day |
Last modified on
| 2026 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071828
