Total Knee ArthroplastyNCT07021287
Effect of Different Cold Therapy Programs in Patients Received Total Knee Arthroplasty Operation
A study testing mixed ice and water, continuous ice application, mixed ice and water, intermittent ice compress and full ice, continuous ice compress in people with Total Knee Arthroplasty, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- mixed ice and water, continuous ice application, mixed ice and water, intermittent ice compress and full ice, continuous ice compress
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 2 sitesChina
- Study dates
- 6 Jul 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years after primary total knee arthroplasty
- No history of open injury or prior surgery in the affected knee
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
4th Affiliated Hospital, School of Medicine, ZhejiangUniversity, China
Yiwu, Zhejiang, 322000
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
Chengli Yan, yanchengli1208@zju.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- mixed ice and water, continuous ice application, mixed ice and water, intermittent ice compress, full ice, continuous ice compress, full ice, intermittent ice compress
- Keywords
- cold therapy;, NRS, GCQ, ROM;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mixed ice and water, continuous ice applicationOther
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 compressOther
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 compressOther
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 compressOther
Within 72h after surgery, the patient applied ice for 20min each time, with an interval of 2h,3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| mixed ice and water, continuous ice application | Experimental | 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. Receives: Other: mixed ice and water, continuous ice application |
| mixed ice and water, intermittent ice compress | Experimental | within 72 hours after operation, the ice compress time was 30 minutes each time, the interval time was 2 hours, 3 times a day Receives: Other: mixed ice and water, intermittent ice compress |
| full ice, continuous ice compress | Experimental | 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 Receives: Other: full ice, continuous ice compress |
| full ice, intermittent ice compress | Experimental | 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. Receives: Other: full ice, intermittent ice compress |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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:
Measured: Day 1, Day2, Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start6 Jul 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng li Yan, Bachelor, Principal investigator, Study Principal investigatorThe Fourth Affiliated Hospital of Zhejiang UniversitySchool of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021287
- Sponsor's protocol ID
- KY-2024-218
- Status last verified
- Jun 2025
- First submitted
- 2 Apr 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07021287
- Acronym / sponsor ID
- KY-2024-218
- Conditions
- Total Knee Arthroplasty
- Keywords
- cold therapy;, NRS, GCQ, ROM;
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 6 Jul 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mixed ice and water, continuous ice application | Experimental | Other: mixed ice and water, continuous ice applicationafter 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 | Experimental | Other: mixed ice and water, intermittent ice compresswithin 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 | Experimental | Other: full ice, continuous ice compressafter 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 | Experimental | Other: full ice, intermittent ice compresswithin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years after primary total knee arthroplasty
- No history of open injury or prior surgery in the affected knee
Key exclusion criteria (7 listed)
- Motor, sensory, or cognitive dysfunction
- History of mental disorders
- Coagulation abnormalities
- Chronic use of oral corticosteroids (>3 months)
- Cold hypersensitivity/allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mixed ice and water, continuous ice applicationthe 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, continuous ice application |
| mixed ice and water, intermittent ice compresswithin 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 | mixed ice and water, intermittent ice compress |
| full ice, continuous ice compressAfter 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, continuous ice compress |
| full ice, intermittent ice compressWithin 72h after surgery, the patient applied ice for 20min each time, with an interval of 2h,3 times a day. | Other | full ice, intermittent ice compress |
Primary outcome
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.
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).
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:
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cheng li Yan, Bachelor principal investigator
Study Principal investigatorThe Fourth Affiliated Hospital of Zhejiang UniversitySchool of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mixed ice and water, continuous ice application, mixed ice and water, intermittent ice compress and full ice, continuous ice compress in people with Total Knee Arthroplasty, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheng li Yan, Bachelor (+8613757179391, yanchengli1208@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numerical rating scale ，NRS (time frame: Day 1, Day2, Day 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.