Tokyo, Aug. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062732) titled 'intervention study on the effect of transcutaneous electrical nerve stimulation on acute pain on the second day after total knee arthroplasty' on Aug. 29.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Shimane University Hospital

Condition: Condition - Knee osteoarthritis Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 100

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071828

Disclaimer: Curated by HT Syndication.