The Clinical Observation on Taping After Total Knee Replacement

Total Knee Replacement Clinical Trial

— taping  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03340584
• Other study ID #: 2017PT1025
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2019
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Songhe Jiang
• Phone: 8613600661860
• Email: 863191168[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Other:
• the Nine Castle Net Format Taping
The intervention group received traditional rehabilitation and Taping throughout all rehabilitation period.The taping including a Nine Castle Net Format of taping in both side of surgery knee.We will exchange the new taping for every two days, for a week.Traditional rehabilitation included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 30 minutes each day, for a week.
• traditional rehabilitation
traditional rehabilitation included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 30 minutes each day, for a week.

Locations

Country	Name	City	State
China	Songhe Jiang	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Knee Edema at 1 week	Leg Circumference Measurements	Baseline and at 1 week
Secondary	Change from Baseline Activities of Daily Living (ADL) at 1 week	The Barthel index	Baseline and at 1 week
Secondary	Change from Baseline Knee Pain 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	Baseline and at 1 week
Secondary	Change from Baseline Knee range of motion at 1 week	The Range of Motion Measurements	Baseline and at 1 week
Secondary	Change from Baseline muscle strength of quadriceps femoris and hamstring at 1 week	Manual Muscle Test(MMT)	Baseline and at 1 week