The Clinical Observation on Taping After Total Knee Replacement (taping)

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

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 Overview

• Status: Unknown
• Conditions: Total Knee Replacement
• Intervention / Treatment: Other: the Nine Castle Net Format Taping; Other: traditional rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Songhe Jiang; Phone Number: 8613600661860; Email: 863191168@qq.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • Songhe Jiang
      • Contact: Songhe Jiang, Professor; Phone Number: 13600661860; Email: 863191168@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The intervention group; 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.	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.
Other: The control group; The control group will be received the traditional rehabilitation during the hospitalization period.The traditional rehabilitation included occupational therapy and physical therapy.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Knee Edema at 1 week	Leg Circumference Measurements	Baseline and at 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Activities of Daily Living (ADL) at 1 week	The Barthel index	Baseline and at 1 week
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
Change from Baseline Knee range of motion at 1 week	The Range of Motion Measurements	Baseline and at 1 week
Change from Baseline muscle strength of quadriceps femoris and hamstring at 1 week	Manual Muscle Test（MMT）	Baseline and at 1 week

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2017
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Pain; Edema; Taping; Total Knee Replacement
• Other Study ID Numbers: 2017PT1025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No