The Clinical Observation on Taping After Total Knee Replacement

Not Applicable

• Conditions: Total Knee Replacement
• Interventions: Other: traditional rehabilitation; Other: the Nine Castle Net Format Taping

• Registration Number: NCT03340584
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-13
• Study Start: 2017-11-25
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-25
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The control group	traditional rehabilitation	The control group will be received the traditional rehabilitation during the hospitalization period.The traditional rehabilitation included occupational therapy and physical therapy.
The intervention group	the Nine Castle Net Format Taping	The intervention group will be received the Nine Castle Net Format taping and the traditional rehabilitation throughout all hospitalization period.We will exchange the new taping for Every two days.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Knee Edema at 1 week	Baseline and at 1 week	Leg Circumference Measurements

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Activities of Daily Living (ADL) at 1 week	Baseline and at 1 week	The Barthel index
Change from Baseline Knee Pain at 1 week	Baseline and at 1 week	Numeric Pain Rating Scale（NPRS）,Numeric Pain Rating Scale on a 1(no pain)to 10(worst pain imaginable)scale, 0 No pain,1 2 3 Mild pain, 4 5 6 Moderate pain,7 8 9 10 Worst possible pain
Change from Baseline muscle strength of quadriceps femoris and hamstring at 1 week	Baseline and at 1 week	Manual Muscle Test（MMT）
Change from Baseline Knee range of motion at 1 week	Baseline and at 1 week	The Range of Motion Measurements

Trial Locations

Locations (1)

Songhe Jiang; 🇨🇳 Wenzhou, Zhejiang, China