UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059103 |
|---|---|
| Receipt number | R000067587 |
| Scientific Title | Effect of Cryotherapy on Maximum Tolerable Current and Knee Extension Power During NMES After Total Knee Arthroplasty: A Pilot Study |
| Date of disclosure of the study information | 2025/09/18 |
| Last modified on | 2025/09/17 06:59:44 |
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Basic information
Public title
Study on the Effects of Cryotherapy and Electrical Stimulation Rehabilitation after Total Knee Arthroplasty
Acronym
CRYO-EMS Study
Scientific Title
Effect of Cryotherapy on Maximum Tolerable Current and Knee Extension Power During NMES After Total Knee Arthroplasty: A Pilot Study
Scientific Title:Acronym
TKA-CRYO-EMS Trial
Region
| Japan |
Condition
Condition
Patients after total knee arthroplasty (TKA)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether cryotherapy administered prior to neuromuscular electrical stimulation (NMES) improves maximum tolerable current intensity (CT) and quadriceps strength in patients after total knee arthroplasty (TKA).
Basic objectives2
Others
Basic objectives -Others
To comprehensively evaluate the effects of cryotherapy combined with NMES by assessing secondary outcomes such as sensory threshold, pain score, skin temperature, knee circumference, inflammatory markers, and pain catastrophizing scale (PCS), thereby examining its clinical utility.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Maximum tolerable current intensity (CT): Assessed on postoperative days 7, 8, 14, and 15, comparing cryotherapy + NMES with NMES alone.
Key secondary outcomes
Quadriceps strength (measured with handheld dynamometer): preoperatively, postoperative days 7, 8, 14, and 15
Electrical sensory threshold: postoperative days 7, 8, 14, and 15
Pain score (Visual Analog Scale, VAS): same as above
Skin temperature (measured with infrared thermometer): same as above
Knee circumference (indicator of joint swelling): preoperatively, postoperative days 7, 8, 14, and 15
Inflammatory markers (CRP from routine blood tests): postoperative day 7 and postoperative day 14
Pain Catastrophizing Scale (PCS): preoperatively
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Name: Cryotherapy + NMES
Period / Number / Frequency: Performed once on postoperative days 7, 8, 14, and 15 (total of 4 sessions).
Time window: 10:00-12:00 am on each assessment day.
Procedure:
Electrodes: Surface electrodes are placed on the quadriceps muscle.
Positioning / Fixation: The knee joint is fixed at 60 deg flexion using an isometric dynamometer (e.g., Cybex). The trunk and thigh are secured with straps, and the distal lower leg is fixed.
NMES settings: Frequency 50 Hz; pulse width 300 us.
Intensity setting (CT measurement): Before the intervention, NMES is applied. The current intensity is gradually increased, and the maximum tolerable current intensity (CT; mA) is recorded. Thereafter, knee extension strength (isometric torque) during NMES at the CT intensity is measured.
Cryotherapy: The anterior knee is cooled for approximately 10 min using an ice pack and elastic bandage. Immediately after cooling, skin temperature is measured with a non-contact thermometer to confirm the cooling effect.
Reassessment: After skin temperature measurement, CT is reassessed, and knee extension strength at the CT intensity is measured again. Three trials are performed with 1 min rest between each trial, and the highest value (normalized to body weight in Nm/kg if necessary) is adopted.
Interventions/Control_2
Name: NMES only (no cryotherapy)
Period / Number / Frequency: Performed once on postoperative days 7, 8, 14, and 15 (total of 4 sessions).
Time window: 10:00-12:00 am on each assessment day. No cryotherapy (ice pack or ice bag) is applied during this period.
Procedure:
Electrodes: Surface electrodes are placed on the quadriceps muscle.
Positioning / Fixation: The knee joint is fixed at 60 deg flexion using an isometric dynamometer (e.g., Cybex). The trunk and thigh are secured with straps, and the distal lower leg is fixed.
NMES settings: Frequency 50 Hz; pulse width 300 us.
Intensity setting (CT measurement): The current intensity is gradually increased, and the maximum tolerable current intensity (CT; mA) is recorded at the point when the participant reports "no longer tolerable".
Strength measurement: At the CT intensity, the isometric knee extension torque generated at the NMES "ON" timing is automatically recorded. Three trials are performed with 1 minute rest intervals, and the highest value (normalized to body weight in Nm/kg if necessary) is adopted.
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo unilateral total knee arthroplasty (TKA) at our hospital between September 2025 and March 2027
Male or female patients aged 60 to 90 years
Patients who were able to walk independently or with a T-cane prior to surgery
Patients who are in a clinically stable condition after surgery and judged to be able to safely undergo postoperative rehabilitation
Patients who understand the content of the study and provide written informed consent
Key exclusion criteria
Patients who have undergone bilateral TKA or revision TKA
Patients with difficulty in understanding instructions due to cerebrovascular disease, neuromuscular disorders, or severe dementia
Patients with cardiac pacemakers or implantable cardioverter-defibrillators (contraindication for NMES)
Patients with skin disorders, surgical site infection, or severe swelling around the knee (making NMES or cryotherapy infeasible)
Patients who develop postoperative readmission or surgical complications (e.g., deep infection, venous thromboembolism)
Patients judged unable to continue physical therapy during the intervention period
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Yamamori |
Organization
Social Medical Corporation Yahata Steel Memorial Hospital
Division name
Department of Rehabilitation
Zip code
8058508
Address
1-1-1 Harunomachi, Yahatahigashi-ku, Kitakyushu-shi, Fukuoka, Japan
TEL
0936719318
yamamori.k@ns.yawata-mhp.or.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Yamamori |
Organization
Social Medical Corporation Yahata Steel Memorial Hospital
Division name
Department of Rehabilitation
Zip code
8058508
Address
1-1-1 Harunomachi, Yahatahigashi-ku, Kitakyushu-shi, Fukuoka, Japan
TEL
0936719318
Homepage URL
yamamori.k@ns.yawata-mhp.or.jp
Sponsor or person
Institute
Social Medical Corporation Yahata Steel Memorial Hospital
Institute
Department
Personal name
Kenta Yamamori
Funding Source
Organization
Social Medical Corporation Yahata Steel Memorial Hospital
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
Social Medical Corporation Yahata Steel Memorial Hospital
Address
1-1-1 Harunomachi, Yahatahigashi-ku, Kitakyushu-shi, Fukuoka , Japan
Tel
0936719318
yamamori.k@ns.yawata-mhp.or.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
| 2025 | Year | 09 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2027 | 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 | 09 | Month | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067587
