Efficacy of Kinesiotaping During Rehabilitation Following Total Knee Replacement Surgery (KT-TKR)

Efficacy of Kinesiotaping During Rehabilitation Following Total Knee Replacement Surgery- a Prospective Randomised Controlled Trial

The aim of this study was to examine the efficacy of Kinesiotaping (KT) within postoperative rehabilitation after Total Knee Replacement (TKR) surgery by determining whether KT enhances early postoperative outcomes, in terms of reduction of swelling, pain relief and improvement in the function of the knee joint, compared to conventional rehabilitation without the use of KT.

Study Overview

• Status: Active, not recruiting
• Conditions: Total Knee Replacement; Postoperative Recovery; Rehabilitation Outcome
• Intervention / Treatment: Device: Kinesiotaping (KT); Other: Standard Rehabilitation

Detailed Description

Kinesiotaping and Rehabilitation after Total Knee Replacement The effectiveness of Kinesiotaping (KT) in postoperative rehabilitation remains scientifically unproven, despite its widespread use. KT is believed to reduce pain and swelling, improve muscle function, and enhance joint mobility by promoting blood flow and lymphatic drainage. However, high-quality studies assessing its efficacy, particularly following Total Knee Replacement (TKR), are lacking.

Aim of the Study The aim of this study is to demonstrate that KT, when applied during inpatient rehabilitation after TKR, improves clinical outcomes compared to standard rehabilitation without KT.

Specifically, the investigators aim to show that:

KT reduces postoperative swelling and pain, thereby enhancing knee function. KT promotes faster recovery of muscle strength and range of motion. KT shortens the time needed to achieve key postoperative milestones, allowing for a more effective rehabilitation process.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Herrenalb, Germany, 76332
    • SRH Health Center Bad Herrenalb

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adults aged ≥18 years.
• Patients who have undergone primary Total Knee Replacement (TKR) with uncomplicated wound conditions.
• No signs of infection post-surgery.
• Ability to understand study procedures and complete required questionnaires.

Exclusion Criteria:

• Revision TKR surgeries.
• Early postoperative complications (e.g., wound healing disorders, deep infections, thrombosis).
• Severe comorbidities (e.g., heart failure NYHA class 3-4, renal insufficiency grade 3-4, chronic lymphedema, dermatological conditions).
• Known allergies to Kinesiotaping (KT) or adhesive materials.
• Neurological or neuromuscular disorders.
• Cognitive impairments (e.g., dementia) affecting compliance.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinesiotaping group; Patients in this group will receive Kinesiotaping (KT) in addition to standard rehabilitation following TKR surgery. KT will be applied using various techniques, including lymphatic, muscle, and ligament taping.	Device: Kinesiotaping (KT); Kinesiotaping will be applied using muscle, lymphatic, and ligament taping techniques to promote healing, reduce swelling, and improve muscle function following total knee replacement surgery.; Other Names: K-Active Tape; Other: Standard Rehabilitation; Patients will receive standard postoperative rehabilitation, including physiotherapy, gait training, and medical exercises, without the application of Kinesiotaping.
Active Comparator: Control group (no KT); Patients in this group will receive standard rehabilitation following TKR surgery without the application of Kinesiotaping.	Other: Standard Rehabilitation; Patients will receive standard postoperative rehabilitation, including physiotherapy, gait training, and medical exercises, without the application of Kinesiotaping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level Using the Numeric Rating Scale (NRS)	Pain Level Using the Numeric Rating Scale (NRS): Pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst possible pain). Unit of Measure: NRS score (0-10), where higher scores indicate worse pain.	From postoperative day 10 to postoperative day 25.
Knee Circumference (Swelling)	Knee Circumference (Swelling): The circumference of the operated knee will be measured using a standard tape measure at a consistent anatomical location. Unit of Measure: Centimeters.	From postoperative day 10 to postoperative day 25.
Passive Range of Motion (PROM)	Passive Range of Motion (PROM): Knee joint mobility (flexion and extension) will be measured using a goniometer. Unit of Measure: Degrees.	From postoperative day 10 to postoperative day 25.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Up and Go Test	Timed Up and Go Test: Measures the time (in seconds) for a patient to rise from a chair, walk 3 meters, turn, and return to the chair. Unit of Measure: Seconds (lower scores indicate better mobility).	From postoperative day 10 to postoperative day 25.
Chair Stand Test	Chair Stand Test: Measures the number of times a patient can rise from a chair and sit down within 30 seconds. Unit of Measure: Count (higher scores indicate better lower limb strength).	From postoperative day 10 to postoperative day 25.
10-Meter Walk Test	10-Meter Walk Test: Measures the time taken to walk 10 meters at a self-selected pace. Unit of Measure: Seconds (lower scores indicate better walking ability).	From postoperative day 10 to postoperative day 25.

Collaborators and Investigators

• Sponsor: SRH Gesundheitszentrum Bad Herrenalb
• Investigators: Study Director: Andreas Veihelmann, MD, PhD, 1 SRH Health-center, Bad Herrenalb, Germany 2 Department of Orthopaedics, Physical Medicine & Rehabilitation, Ludwig-Maximilians- University of Munich, Munich, Germany 3 Department for Spine Therapy, Sports Hospital Stuttgart, Stuttgart, Germany

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 8, 2025
• First Submitted That Met QC Criteria: February 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 15, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Kinesiotaping; Total Knee Replacement; Pain Relief; knee joint Function
• Other Study ID Numbers: Study2024-BadHerrenalb-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share de-identified individual participant data that underlie the results reported in the publication, including data on primary and secondary outcomes (e.g., pain levels, knee circumference, range of motion, functional tests). Access to data will be available upon reasonable request to researchers conducting relevant studies. Data will be shared following publication and will be accessible for up to 5 years. Researchers must submit a formal proposal, and data sharing agreements will be required to protect privacy and confidentiality.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No