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Recruiting NCT07021287

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

No phase Interventional Total Knee Arthroplasty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mixed ice and water, continuous ice application, mixed ice and water, intermittent ice compress, full ice, continuous ice compress, full ice, intermittent ice compress.
Who it may be relevant to
Registry conditions: Total Knee Arthroplasty. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Different Cold Therapy Programs on NRS(Numerical Rating Scale),ROM(Range of Motion),GCQ(General Comfort Questionnaire), and Swell in Patients Received Total Knee Arthroplasty Operation

Overview

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.

Detailed 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.

Interventions

  • Other mixed ice and water, continuous ice application
    the ice pack was placed on the knee joint immediately after returning to the ward for 24 hours, and the ice pack was replaced every 3 to 4 hours, if it melted, replaced immediately.
  • Other mixed ice and water, intermittent ice compress
    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
  • Other full ice, continuous ice compress
    After returning to the ward, an ice pack should be placed on the knee for 24 hours. The ice pack should be replaced every 3-4 hours and replaced immediately if melted
  • Other full ice, intermittent ice compress
    Within 72h after surgery, the patient applied ice for 20min each time, with an interval of 2h,3 times a day.

Primary outcome measures

  • numerical rating scale ,NRS [Time frame: Day 1, Day2, Day 3]
  • general comfort questionnaire,GCQ [Time frame: Day 1, Day2, Day 3]
  • Joint range of motion (ROM), knee swelling [Time frame: Day 1, Day2, Day 3]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Supportive care

Study locations

China · 2 centers
  • 4th Affiliated Hospital, School of Medicine, ZhejiangUniversity, China — Yiwu
  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine — Yiwu

Identifiers

NCT: NCT07021287 · KY-2024-218

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗