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Clinical Trials/NCT03340584
NCT03340584UnknownNot Applicable

The Effectiveness of the Nine Castle Net Format Taping After Total Knee Replacement in Early Postoperative Rehabilitation Period. A Randomized Controlled Trial

Second Affiliated Hospital of Wenzhou Medical University1 site in 1 country100 target enrollmentStarted: November 25, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Change from Baseline Knee Edema at 1 week
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The investigators will conduct a single-blind, randomized controlled trial of 100 patients with total knee replacement. Patients will be randomly assigned into a control group and an intervention group.Both groups received same rehabilitation procedures after surgery,except intervention group also received taping applications throughout all rehabilitation period.Then, the patients will be reevaluated to determine changes in lower extremity function, edema, pain,knee range of motion, and muscle strength of quadriceps femoris and hamstring.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •soft-tissue swelling and pain after total knee replacement
  • •agree to participate the study and signing of informed consent

Exclusion Criteria

  • •severe cognitive and language barriers that can not be used to evaluate patients with pain and swelling
  • •failure of important organs, such as heart, lung, liver and kidney
  • •deep venous thrombosis
  • •thrombophlebitis
  • •varicose veins (stage II-IVaccording to Marshall) and venous insufficiency (stadium 2-3 according to Widmer)
  • •participants with infection in the areas close to the knee joint, or allergy to tape
  • •enrollment in another clinical trial involving physical therapy or an investigational drug

Outcomes

Primary Outcomes

Change from Baseline Knee Edema at 1 week

Time Frame: Baseline and at 1 week

Leg Circumference Measurements

Secondary Outcomes

  • Change from Baseline Activities of Daily Living (ADL) at 1 week(Baseline and at 1 week)
  • Change from Baseline Knee Pain at 1 week(Baseline and at 1 week)
  • Change from Baseline muscle strength of quadriceps femoris and hamstring at 1 week(Baseline and at 1 week)
  • Change from Baseline Knee range of motion at 1 week(Baseline and at 1 week)

Investigators

Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Song-he Jiang

Principal Investigator

Second Affiliated Hospital of Wenzhou Medical University

Study Sites (1)

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