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NCT Number: NCT07021287

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

4th Affiliated Hospital, School of Medicine, ZhejiangUniversity, China, Yiwu, Zhejiang, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mixed ice and water, continuous ice application

Other

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.

mixed ice and water, intermittent ice compress

Other

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

full ice, continuous ice compress

Other

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

full ice, intermittent ice compress

Other

Within 72h after surgery, the patient applied ice for 20min each time, with an interval of 2h,3 times a day.

Primary outcomes

  1. numerical rating scale ,NRS

    Time frame: Day 1, Day2, Day 3

    ostoperative pain intensity will be evaluated using the Numerical Rating Scale (NRS) at 24 hours following total knee arthroplasty (TKA). The NRS is an 11-point scale ranging from 0 to 10, where 0 represents "no pain" and 10 indicates "the worst imaginable pain." Patients will self-report their pain level by selecting a numerical value corresponding to their perceived intensity. The scale is visually presented as a 10-cm horizontal line divided into 10 equal segments, with each segment labeled sequentially from 0 to 10.

  2. general comfort questionnaire,GCQ

    Time frame: Day 1, Day2, Day 3

    GCQ was developed by the famous nursing scientist Kekaba. In 2004, it was sinicized by Chinese scholar Julixia et al. It is suitable for all kinds of people with discomfort. The scale contains four dimensions of physiology, psychology, environment and social culture, a total of 28 items, using 1-4 Likert scores, with 1 indicating "strongly disagree" and 4 indicating "strongly agree". The total scores range from 28 to 112. That is, patients were in low comfort (total score < 60), moderate comfort (60-90 points) and high comfort (> 90 points). Clinical research found that the scale had good reliability and validity (Cronbach's α coefficient was 0.893).

  3. Joint range of motion (ROM), knee swelling

    Time frame: Day 1, Day2, Day 3

    Range of Motion (ROM)

    Range of Motion (ROM), also termed joint range of motion, refers to the maximum arc of movement achievable by a joint during motion. ROM is categorized into two types based on the force driving the movement:

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng li Yan, Bachelor

CONTACT

[email protected]

+8613757179391

Yu yu Chen, Master

CONTACT

[email protected]

13958423189

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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