search
Back to results

The Effects of Manual Lymphatic Drainage and Kinesiotaping on Lower Extremity Edema

Primary Purpose

Total Knee Arthroplasty, Edema, Exercise

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manual Lymphatic Drainage
Kinesio Taping
Control
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Arthroplasty

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • TKA surgery

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Kinesio Taping

    Manual Lymphatic Drainage

    Control

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Circumference measurements
    Circumference measurements

    Secondary Outcome Measures

    Knee Injury and Osteoarthritis Outcome Score (KOOS)
    Knee Injury and Osteoarthritis Outcome Score (KOOS) evaluates the functional status of knee joint. total points range between 0-100 points. higher points represents a better outcome. total score is the averaged subscales.

    Full Information

    First Posted
    June 14, 2018
    Last Updated
    November 14, 2019
    Sponsor
    Hacettepe University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04164927
    Brief Title
    The Effects of Manual Lymphatic Drainage and Kinesiotaping on Lower Extremity Edema
    Official Title
    The Effects of Manual Lymphatic Drainage and Kinesiotaping on Lower Extremity Edema and Functional Outcomes in Patients With Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    August 30, 2015 (Actual)
    Study Completion Date
    January 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Procedures: Patients who underwent unilateral TKA were randomized as Kinesio Taping® group, MLD group and control group. For all patients, postoperative rehabilitation program included early mobilization and physical therapy twice a day during the stay in orthopedic traumatology department. On the second day after surgery, lymphatic correction method was used on the Kinesio Taping® group patients and a standardized 30-minute MLD treatment was applied to the MLD group patients. Control group received only physiotherapy treatment. Circumference measurements were applied on preoperatively and the second, third, fourth day and 6th weeks after surgery. Knee Injury and Osteoarthritis Outcome Score (KOOS) was used to determine the functional outcomes on the 6th weeks after surgery. Repeated measures of variance analysis was used to determine time differences between groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Total Knee Arthroplasty, Edema, Exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kinesio Taping
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Manual Lymphatic Drainage
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Manual Lymphatic Drainage
    Intervention Description
    Lymphatic correction method was used via the KinesioTaping® to patients group. Standardized 30-minute Manuel Lymphatic Drainage treatment was applied to the MLD group. Control group received only physiotherapy treatment.
    Intervention Type
    Other
    Intervention Name(s)
    Kinesio Taping
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Circumference measurements
    Description
    Circumference measurements
    Time Frame
    This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery
    Secondary Outcome Measure Information:
    Title
    Knee Injury and Osteoarthritis Outcome Score (KOOS)
    Description
    Knee Injury and Osteoarthritis Outcome Score (KOOS) evaluates the functional status of knee joint. total points range between 0-100 points. higher points represents a better outcome. total score is the averaged subscales.
    Time Frame
    This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: TKA surgery Exclusion Criteria: active infection malignant tumor major cardiac pathology, or thrombus or venous obstruction that was pre-diagnosed or revealed on a routine preadmission hospital screening
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hande Güney Deniz, assoc. prof.
    Organizational Affiliation
    Hacettepe University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26829760
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23810354
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    The Effects of Manual Lymphatic Drainage and Kinesiotaping on Lower Extremity Edema

    We'll reach out to this number within 24 hrs