Effect of Different Cold Therapy Programs in Patients Received Total Knee Arthroplasty Operation
1 other identifier
interventional
260
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 6, 2024
CompletedFirst Submitted
Initial submission to the registry
April 2, 2025
CompletedFirst Posted
Study publicly available on registry
June 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedJune 13, 2025
June 1, 2025
1.7 years
April 2, 2025
June 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
numerical rating scale ，NRS
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.
Day 1, Day2, Day 3
general comfort questionnaire，GCQ
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).
Day 1, Day2, Day 3
Joint range of motion (ROM), knee swelling
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:
Day 1, Day2, Day 3
Study Arms (4)
mixed ice and water, continuous ice application
EXPERIMENTALafter 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.
mixed ice and water, intermittent ice compress
EXPERIMENTALwithin 72 hours after operation, the ice compress time was 30 minutes each time, the interval time was 2 hours, 3 times a day
full ice, continuous ice compress
EXPERIMENTALafter 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
full ice, intermittent ice compress
EXPERIMENTALwithin 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.
Interventions
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.
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
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
Within 72h after surgery, the patient applied ice for 20min each time, with an interval of 2h,3 times a day.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years after primary total knee arthroplasty
- No history of open injury or prior surgery in the affected knee
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
4th Affiliated Hospital, School of Medicine, ZhejiangUniversity, China
Yiwu, Zhejiang, 322000, China
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheng li Yan, Bachelor
Study Principal investigatorThe Fourth Affiliated Hospital of Zhejiang UniversitySchool of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2025
First Posted
June 13, 2025
Study Start
July 6, 2024
Primary Completion
April 1, 2026
Study Completion
June 1, 2026
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share