NCT04164927

Brief Summary

Significant trauma and muscular tightness often result during Total Knee Arthroplasty (TKA) surgery and thus act to restrict tissue fluid movement resulting with lower extremity edema. Kinesio Taping® is applied directly on the skin for restoration of normal fluid perfusion, removing congestion of lymphatic fluid or hemorrhages. In addition Manual Lymphatic Drainage (MLD) enhances blood circulation and stimulates the lymphatic movement and unblocks lymphatic territories. The aim of the study was to investigate the effectiveness of Kinesio Taping® and MLD in reducing postoperative edema and pain in the early stage after TKA.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2018

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

8 months

First QC Date

June 14, 2018

Last Update Submit

November 14, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Circumference measurements

    Circumference measurements

    This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery

Secondary Outcomes (1)

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery

Study Arms (3)

Kinesio Taping

ACTIVE COMPARATOR

Lymphatic correction method is applied via Kinesiotaping depending on the size of the leg two or three fan-cut tape was applied with light paper-off tension on the frontal, medial and lateral aspects of the limb. Certified Kinesio Tape practitioner applied Kinesiotaping on the second day (day 2) post-surgery and once a week.

Other: Manual Lymphatic DrainageOther: Control

Manual Lymphatic Drainage

ACTIVE COMPARATOR

A standardized 30-minute manual lymphatic drainage (MLD) treatment is applied to MLD group. On the second day (day 2) post-surgery, patients allocated to the MLD group underwent a standardized 30 minute MLD treatment on the operated limb by an experienced remedial massage therapist trained in delivering MLD.

Other: Kinesio TapingOther: Control

Control

NO INTERVENTION

Standard postoperative rehabilitation program is applied to Control Group. Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures.

Interventions

1. Lymphatic correction method was used via the KinesioTaping® to patients group. 2. Standardized 30-minute Manuel Lymphatic Drainage treatment was applied to the MLD group. 3. Control group received only physiotherapy treatment.

Kinesio Taping

Depending on the size of the leg two or three fan cut tapes were applied with light paper-off tension on the frontal, medial and lateral aspects of the limb. Kinesio taping was applied by certified Kinesio Tape practitioner once a week to Kinesiotaping group.

Manual Lymphatic Drainage
ControlOTHER

Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures. These exercises were undertaken in sets of 10 repetitions, 3 times daily; the physiotherapist was present to assist, as required, on 2 occasions per day for the first 3 postoperative days and then once daily from day 4 until hospital discharge.

Kinesio TapingManual Lymphatic Drainage

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • TKA surgery

You may not qualify if:

  • active infection
  • malignant tumor
  • major cardiac pathology, or thrombus or venous obstruction that was pre-diagnosed or revealed on a routine preadmission hospital screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Pichonnaz C, Bassin JP, Lecureux E, Christe G, Currat D, Aminian K, Jolles BM. Effect of Manual Lymphatic Drainage After Total Knee Arthroplasty: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 May;97(5):674-82. doi: 10.1016/j.apmr.2016.01.006. Epub 2016 Jan 30.

    PMID: 26829760BACKGROUND
  • Ebert JR, Joss B, Jardine B, Wood DJ. Randomized trial investigating the efficacy of manual lymphatic drainage to improve early outcome after total knee arthroplasty. Arch Phys Med Rehabil. 2013 Nov;94(11):2103-11. doi: 10.1016/j.apmr.2013.06.009. Epub 2013 Jun 26.

    PMID: 23810354BACKGROUND

MeSH Terms

Conditions

EdemaMotor Activity

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

Study Officials

  • Hande Güney Deniz, assoc. prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 14, 2018

First Posted

November 15, 2019

Study Start

January 1, 2015

Primary Completion

August 30, 2015

Study Completion

January 1, 2016

Last Updated

November 15, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share