Comparing cold-therapy programs after total knee replacement
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
Run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · NCT07021287 · Data updated 2026-11-12
We'll test different cold-therapy methods—ice packs versus ice water, and continuous versus intermittent cooling—to see which reduces pain and improves comfort after total knee replacement.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 260 (estimated) |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 2 sites (Yiwu, Zhejiang and 1 other locations) |
| Status | Recruiting |
| Started | July 6, 2024 |
| Main results expected | April 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | June 13, 2025 |
| Trial ID | NCT07021287 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) who have undergone primary total knee arthroplasty with no prior open injury or surgery to the affected knee and without cold hypersensitivity, coagulation abnormalities, thyroid disease, cognitive impairment, or chronic corticosteroid use.
✕Probably not a fit
Patients with cold hypersensitivity or allergy, coagulation disorders, thyroid disease, motor/sensory or cognitive dysfunction, chronic steroid use, or prior knee surgery are excluded and unlikely to receive benefit from these cooling protocols.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional trial assigns adults who have had primary total knee arthroplasty to different cold-therapy protocols that vary by form (ice pack vs. ice water), temperature, and frequency (continuous vs. intermittent). Outcomes include pain measured by NRS, patient comfort measured by the General Comfort Questionnaire (GCQ), and knee range of motion (ROM). Key exclusions include cold hypersensitivity, coagulation disorders, thyroid disease, cognitive or sensory/motor dysfunction, chronic corticosteroid use, and prior open knee surgery. The study is conducted at the Fourth Affiliated Hospital of Zhejiang University School of Medicine in Yiwu to generate practical guidance for postoperative cooling therapy.
Why it matters
Potential benefit: If successful, the optimal cooling program could reduce postoperative pain and swelling, lower reliance on pain medicines, speed rehabilitation, and improve overall patient comfort and satisfaction.
How similar studies have gone: Cold therapy is commonly used and prior studies show it can reduce postoperative pain and swelling, but the best combination of form, temperature, and timing has not been well established in direct comparisons.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
4th Affiliated Hospital, School of Medicine, ZhejiangUniversity, China
Yiwu, Zhejiang, China Recruiting -
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Cheng li Yan, Bachelor — Study Principal investigatorThe Fourth Affiliated Hospital of Zhejiang UniversitySchool of Medicine
- Study coordinator: Cheng li Yan, Bachelor
- Email: yanchengli1208@zju.edu.cn
- Phone: +8613757179391
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.