Effectiveness Comparison Between Continuous Cryotherapy and Ice Pack Therapy After Anterior Cruciate Ligament Reconstruction Surgery

October 3, 2024 updated by: University Medical Center Ho Chi Minh City (UMC)
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Ho Chi Minh
      • Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000
        • University Medical Center, Ho Chi Minh City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having anterior cruciate ligament reconstruction
  • Agree to be enrolled in study

Exclusion Criteria:

  • Complex knee injury
  • Raynard's disease
  • Sensitive to low temperature
  • Do not want to use cryotherapy
  • Have vascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional ice treatment
Procedure: Conventional ice treatment
Using icepack around knee after anterior cruciate ligament reconstruction for 3 postoperative days
Experimental: Continuous compression cryotherapy
Procedure: Continuous compression cryotherapy
Using continuous compression cryotherapy around knee after anterior cruciate ligament reconstruction for 3 postoperative days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: 3 days postoperative
Compare postoperative Pain score
3 days postoperative
Knee effusion
Time Frame: 3 days postoperative
Compare knee swelling rate
3 days postoperative
Knee range of motion
Time Frame: 3 days postoperative
Range of motion in knee postoperatively
3 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Ho Chi Minh City (UMC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCHoChiMinh

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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