Effectiveness Comparison Between Continuous Cryotherapy and Ice Pack Therapy After Anterior Cruciate Ligament Reconstruction Surgery
1 other identifier
interventional
72
1 country
1
Brief 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 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedFirst Submitted
Initial submission to the registry
October 3, 2024
CompletedFirst Posted
Study publicly available on registry
October 8, 2024
CompletedOctober 8, 2024
June 1, 2023
1.1 years
October 3, 2024
October 3, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Visual Analog Scale
Compare postoperative Pain score
3 days postoperative
Knee effusion
Compare knee swelling rate
3 days postoperative
Knee range of motion
Range of motion in knee postoperatively
3 days postoperative
Study Arms (2)
Conventional ice treatment
ACTIVE COMPARATORContinuous compression cryotherapy
EXPERIMENTALInterventions
Using continuous compression cryotherapy around knee after anterior cruciate ligament reconstruction for 3 postoperative days
Using icepack around knee after anterior cruciate ligament reconstruction for 3 postoperative days
Eligibility Criteria
You may qualify if:
- Having anterior cruciate ligament reconstruction
- Agree to be enrolled in study
You may not qualify if:
- Complex knee injury
- Raynard's disease
- Sensitive to low temperature
- Do not want to use cryotherapy
- Have vascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center, Ho Chi Minh city
Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam
Related Publications (1)
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.
PMID: 40540943DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2024
First Posted
October 8, 2024
Study Start
June 1, 2023
Primary Completion
July 1, 2024
Study Completion
July 1, 2024
Last Updated
October 8, 2024
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share