Postoperative Pain, AcutePhase 2/3NCT06629285
Effectiveness Comparison Between Continuous Cryotherapy and Ice Pack Therapy After Anterior Cruciate Ligament Reconstruction Surgery
A Phase 2/3 study testing Continuous compression cryotherapy and Conventional ice treatment in people with Postoperative Pain, Acute and Anterior Cruciate Ligament Injuries, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial summary
A randomized controlled trial study conducted by comparing the VAS score, swelling condition, knee ROM and patient's satisfactory score between applying ice pack cold therapy and applying continuous compressive cryotherapy in a postoperative three-day period of anterior cruciate ligament reconstruction surgery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Acute, Anterior Cruciate Ligament Injuries, Cryotherapy Effect
- What is being tested?
- Continuous compression cryotherapy and Conventional ice treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jun 2023to 1 Jul 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having anterior cruciate ligament reconstruction
- Agree to be enrolled in study
Who cannot join
- Complex knee injury
- Raynard's disease
- Sensitive to low temperature
- Do not want to use cryotherapy
- Have vascular disease
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
University Medical Center, Ho Chi Minh city
Ho Chi Minh City, Ho Chi Minh, 700000
About this study
A randomized controlled trial study conducted by comparing the VAS score, swelling condition, knee ROM and patient's satisfactory score between applying ice pack cold therapy and applying continuous compressive cryotherapy in a postoperative three-day period of anterior cruciate ligament reconstruction surgery patients.
- Being tested
- Continuous compression cryotherapy, Conventional ice treatment
- Medical subject headings
- Pain, Postoperative, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous compression cryotherapyProcedure or surgery
Using continuous compression cryotherapy around knee after anterior cruciate ligament reconstruction for 3 postoperative days
Conventional ice treatmentProcedure or surgery
Using icepack around knee after anterior cruciate ligament reconstruction for 3 postoperative days
| Study group | Role | What they receive |
|---|---|---|
| Conventional ice treatment | Active comparator | Not described Receives: Procedure: Conventional ice treatment |
| Continuous compression cryotherapy | Experimental | Not described Receives: Procedure: Continuous compression cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Compare postoperative Pain score
Measured: 3 days postoperative
Knee effusion
Compare knee swelling rate
Measured: 3 days postoperative
Knee range of motion
Range of motion in knee postoperatively
Measured: 3 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Jun 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain, AcuteStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629285
- Sponsor's protocol ID
- UMCHoChiMinh
- Status last verified
- Jun 2023
- First submitted
- 3 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Tran LTK, Nguyen QTK, Hoang HQ, Nguyen B, Pham VQ. Enhancing patient outcomes after anterior cruciate ligament reconstruction with continuous cryotherapy: A Nursing-Focused Randomized Control Trial. Int J Orthop Trauma Nurs. 2025 Aug;58:101206. doi: 10.1016/j.ijotn.2025.101206. Epub 2025 Jun 11.
PubMed 40540943
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Comparison Between Continuous Cryotherapy and Ice Pack Therapy After Anterior Cruciate Ligament Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT06629285
- Acronym / sponsor ID
- UMCHoChiMinh
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 8 Oct 2024 (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.
A randomized controlled trial study conducted by comparing the VAS score, swelling condition, knee ROM and patient's satisfactory score between applying ice pack cold therapy and applying continuous compressive cryotherapy in a postoperative three-day period of anterior cruciate ligament reconstruction surgery patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ice treatment | Active comparator | Procedure: Conventional ice treatment |
| Continuous compression cryotherapy | Experimental | Procedure: Continuous compression cryotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having anterior cruciate ligament reconstruction
- Agree to be enrolled in study
Key exclusion criteria (5 listed)
- Complex knee injury
- Raynard's disease
- Sensitive to low temperature
- Do not want to use cryotherapy
- Have vascular disease
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 |
|---|---|---|
| Continuous compression cryotherapyUsing continuous compression cryotherapy around knee after anterior cruciate ligament reconstruction for 3 postoperative days | Procedure or surgery | Continuous compression cryotherapy |
| Conventional ice treatmentUsing icepack around knee after anterior cruciate ligament reconstruction for 3 postoperative days | Procedure or surgery | Conventional ice treatment |
Primary outcome
Visual Analog Scale
Time frame: 3 days postoperative
Compare postoperative Pain score
Knee effusion
Time frame: 3 days postoperative
Compare knee swelling rate
Knee range of motion
Time frame: 3 days postoperative
Range of motion in knee postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Derived from this study: PubMed 40540943Tran LTK, Nguyen QTK, Hoang HQ, Nguyen B, Pham VQ. Enhancing patient outcomes after anterior cruciate ligament reconstruction with continuous cryotherapy: A Nursing-Focused Randomized Control Trial. Int J Orthop Trauma Nurs. 2025 Aug;58:101206. doi: 10.1016/j.ijotn.2025.101206. Epub 2025 Jun 11.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Continuous compression cryotherapy and Conventional ice treatment in people with Postoperative Pain, Acute and Anterior Cruciate Ligament Injuries, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
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 5 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: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 3 days postoperative). 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?
On the ClinicalTrials.gov record for NCT06629285, which also lists 1 linked publication.
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 8 Oct 2024.