Tokyo, Dec. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060061) titled 'The Effect of Cold Therapy in the Early Postoperative Period on Pain During Weight-Bearing and Weight-Bearing Ratio in Proximal Femoral Fractures' on Dec. 12.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Jousai International University

Condition: Condition - Proximal femur fracture (femoral neck fracture, trochanteric fracture) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Proximal femoral fractures are common in the elderly, requiring early weight-bearing and walking initiation postoperatively. Postoperative inflammation and acute pain inhibit weight-bearing on the affected side and delay walking acquisition. Therefore, methods to reduce inflammation and pain while promoting weight-bearing are needed. Icing is considered effective for reducing pain and inflammation, but no reports have examined its effects on weight-bearing rate and walking ability when applied immediately before exercise therapy. This study aimed to clarify the effects of icing immediately before exercise therapy on weight-bearing ratio, weight-bearing pain, motor function, walking ability, and CRP levels. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Icing was performed using wet ice made by adding 50 mL of water to 500 g of pure ice. The application site was directly above the wound, and icing was administered for four consecutive days immediately before the start of physical therapy. The intervention frequency was once daily, with each icing session lasting 20 minutes. Interventions/Control_2 - The control group did not perform icing immediately before rehabilitation, but both groups were similarly permitted to use general icing in the ward (for pain management purposes).

Eligibility: Age-lower limit - 50 years-old

Gender - Male and Female Key inclusion criteria - Patients undergoing acute postoperative care who underwent total hip arthroplasty or intramedullary nailing for proximal femoral fractures between April and November 2025. Key exclusion criteria - Exclusion criteria were defined as having a history of disease in the knee or ankle joint on the operative side, having a disease likely to affect blood data, or having weight-bearing restrictions postoperatively. Target Size - 48

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 03 Month 15 Day Date of IRB - 2025 Year 09 Month 20 Day Anticipated trial start date - 2025 Year 04 Month 01 Day Last follow-up date - 2025 Year 12 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068659

Disclaimer: Curated by HT Syndication.