Tokyo, July 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058531) titled 'Effectiveness of Rehabilitation Interventions for the Prevention of Chronic Pain After Periarticular Knee Osteotomy' on July 21.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Department of Clinical Research Center, Fukuoka Orthopaedic Hospital, Fukuoka, Japan

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

Objective: Narrative objectives1 - The purpose of this study is to evaluate the preventive effect of wearable transcutaneous electrical nerve stimulation (TENS) on chronic post-surgical pain (CPSP) following around the knee osteotomy (AKO). The intervention involves the application of TENS from the early postoperative period at the initiation of weight-bearing, aiming to alleviate pain during weight-bearing and walking. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - In the intervention group, rehabilitation combined with a wearable transcutaneous electrical nerve stimulation (TENS) device will be performed for 3 weeks, starting from postoperative day 15 at the initiation of weight-bearing. Interventions/Control_2 - In the control group, sham TENS without electrical stimulation will be applied for 3 weeks.

Eligibility: Age-lower limit - 40 years-old = Gender - Male and Female Key inclusion criteria - This study targets patients undergoing proximal tibial osteotomy (PTO) for knee osteoarthritis. Key exclusion criteria - Patients with osteonecrosis, posterior root tears of the medial meniscus, neuromuscular diseases, or similar conditions will be excluded. Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 01 Day Anticipated trial start date - 2025 Year 08 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066932

Disclaimer: Curated by HT Syndication.