Effect of Different Cold Therapy Programs in Patients Received Total Knee Arthroplasty Operation

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status: Enrolling

Conditions: Total Knee Arthroplasty

Treatments: Other: full ice, intermittent ice compress; Other: full ice, continuous ice compress; Other: mixed ice and water, continuous ice application; Other: mixed ice and water, intermittent ice compress

Study type: Interventional

Funder types: Other

Identifiers

NCT07021287

KY-2024-218

Details and patient eligibility

About

This study conducts clinical experiments on the form, temperature, frequency and other issues of cooling therapy, so as to provide scientific evidence for the practice of cooling therapy and improve the comfort and effect of cooling therapy, so as to achieve the goal of improving service and patient experience proposed by the National Health Commission.

Full description

Knee osteoarthritis (KOA) is a degenerative joint disease that severely impacts patients' quality of life, primarily manifesting as knee pain and restricted mobility [1]. According to the Osteoarthritis Diagnosis and Treatment Guidelines (2018 Edition) [1], the prevalence of symptomatic knee osteoarthritis in China is 8.1%. Total knee arthroplasty (TKA) is primarily indicated for elderly patients with severe late-stage KOA-related pain and functional impairment. TKA not only improves knee function and corrects deformities but also significantly enhances patients' quality of life. Research by Feng et al. [2] demonstrates a rapid increase in TKA cases in China, rising from 53,880 cases in 2011 to 374,833 cases in 2019-a 5.9-fold growth. However, moderate to severe postoperative pain following TKA remains a major challenge, adversely affecting rehabilitation, patient satisfaction, and clinical outcomes .

Current postoperative pain management strategies for TKA include pharmacological and non-pharmacological interventions. While pharmacological approaches are relatively well-established and effective, they carry side effects such as nausea, vomiting, dizziness, and dependency. Non-pharmacological interventions include cold therapy, localized elastic bandage compression, limb elevation, and early rehabilitation exercises [5-7]. Cold therapy, a simple and cost-effective physical intervention, involves applying ice packs or cold water to reduce skin temperature, thereby decreasing local tissue metabolism, promoting vasoconstriction, reducing edema and hematoma formation, and slowing nerve conduction to alleviate pain. Additionally, cold therapy mitigates local inflammatory responses and blood loss, effectively improving pain and patient comfort .

Existing studies on cold therapy at varying temperatures for TKA are limited, with significant discrepancies in recommended application durations . Excessively low temperatures risk superficial or deep tissue frostbite, nerve damage, and even deep vein thrombosis or necrosis, while insufficient cooling may compromise analgesic and anti-inflammatory efficacy . Although cold therapy is widely adopted post-TKA, critical parameters-such as modality, temperature, frequency, and duration-remain controversial in clinical practice.

This study aims to address these unresolved issues through a clinical trial, generating scientific evidence to optimize cold therapy protocols. The findings will enhance patient comfort and therapeutic outcomes, aligning with the National Health Commission's goals of improving healthcare services and patient experiences.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years after primary total knee arthroplasty
• No history of open injury or prior surgery in the affected knee

Exclusion criteria

• Motor, sensory, or cognitive dysfunction
• History of mental disorders
• Coagulation abnormalities
• Chronic use of oral corticosteroids (>3 months)
• Cold hypersensitivity/allergy
• Withdrawal due to non-study-related reasons
• Thyroid disease

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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260 participants in 4 patient groups

mixed ice and water, continuous ice application

Experimental group

Description:

after returning to the ward, the ice pack was placed on the knee joint for 24 hours, and the ice pack was replaced every 3 to 4 hours, if it melted, replaced immediately.

Treatment:

Other: mixed ice and water, continuous ice application

mixed ice and water, intermittent ice compress

Experimental group

Description:

within 72 hours after operation, the ice compress time was 30 minutes each time, the interval time was 2 hours, 3 times a day

Treatment:

Other: mixed ice and water, intermittent ice compress

full ice, continuous ice compress

Experimental group

Description:

after returning to the ward, the ice pack was placed on the knee joint for 24 hours, and the ice pack was replaced every 3 to 4 hours, if it melted, replaced immediately

Treatment:

Other: full ice, continuous ice compress

full ice, intermittent ice compress

Experimental group

Description:

within 72 hours after operation, the patients were given ice compress for 20 minutes each time, with an interval of 2 hours, 3 times a day.

Treatment:

Other: full ice, intermittent ice compress