Efficacy of Kinesiotaping During Rehabilitation Following Total Knee Replacement Surgery

NCT06831682 | Active Not Recruiting DMC

• 1 other identifier: Study2024-BadHerrenalb-01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Replacement; Postoperative Recovery; Rehabilitation Outcome

Keywords

Kinesiotaping; Total Knee Replacement; Rehabilitation; knee joint Function; Pain Relief

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Timed Up and Go Test

  From postoperative day 10 to postoperative day 25.

• Chair Stand Test

  From postoperative day 10 to postoperative day 25.

• 10-Meter Walk Test

  From postoperative day 10 to postoperative day 25.

Study Arms (2)

Kinesiotaping group

EXPERIMENTAL

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); Other: Standard Rehabilitation

Control group (no KT)

ACTIVE COMPARATOR

Patients in this group will receive standard rehabilitation following TKR surgery without the application of Kinesiotaping.

Other: Standard Rehabilitation

Interventions

Kinesiotaping (KT) DEVICE

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.

Also known as: K-Active Tape

Kinesiotaping group

Standard Rehabilitation OTHER

Patients will receive standard postoperative rehabilitation, including physiotherapy, gait training, and medical exercises, without the application of Kinesiotaping.

Control group (no KT); Kinesiotaping group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SRH Gesundheitszentrum Bad Herrenalb: lead

Study Sites (1)

SRH Health Center Bad Herrenalb

Bad Herrenalb, Bad Herrenalb, 76332, Germany

Location

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 18, 2025
• Study Start: February 8, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

DE (1)