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Study on the Effects of Cryotherapy and Electrical Stimulation Rehabilitation after Total Knee Arthroplasty

Effect of Cryotherapy on Maximum Tolerable Current and Knee Extension Power During NMES After Total Knee Arthroplasty: A Pilot Study - TKA-CRYO-EMS Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059103
Enrollment
20
Registered
2025-09-18
Start date
2025-09-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients after total knee arthroplasty (TKA)

Interventions

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:
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 p

Sponsors

Social Medical Corporation Yahata Steel Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Maximum tolerable current intensity (CT): Assessed on postoperative days 7, 8, 14, and 15, comparing cryotherapy + NMES with NMES alone.

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactKenta Yamamori

Social Medical Corporation Yahata Steel Memorial Hospital Department of Rehabilitation

yamamori.k@ns.yawata-mhp.or.jp0936719318

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026