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The Efficacy of Kinesio Taping on Lymphedema Following Head and Neck Cancer Therapy

Primary Purpose

Lymphedema, Head and Neck Cancer, Kinesio Taping

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio Tex Gold
Sponsored by
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring Kinesio taping, neck, lymphedema, head, cancer, therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18-70 years
  • External neck lymphedema
  • Head and neck cancer treatment patients
  • patients who have not open wound on neck
  • Patients who were accept to consent form

Exclusion Criteria:

  • Mental disorders Cognitive limitations Pregnancy Out of age 18-70 years old Patients who were not accept to consent form

Sites / Locations

  • Prof Dr Cemil Tascioglu City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Kinesio taping study

Kinesio taping sham

Arm Description

Kinesio tex gold tape was applied to neck localised lymphedema as stretched. Kinesio tape maintained during consecutive days and also were re applied with manual lymphatic drainage therapy as 5 times first week, and afterthat 2 times for 3 weeks (total 4 weeks)

Kinesio tex gold tape was applied to neck localised lymphedema as no-stretched. Kinesio tape maintained during consecutive days and also were re applied with manual lymphatic drainage therapy as 5 times first week, and afterthat 2 times for 3 weeks (total 4 weeks)

Outcomes

Primary Outcome Measures

The values of diameter of lymphedema of neck with face
The diameters of upper, middle and lower points of neck were measured with tailor meter by a Physical Medicine and Rehabilitation professionals (measure unit is cm).
The values of diameter of lymphedema of neck with face
The diameters of upper, middle and lower points of neck and two points of face were measured with tailor meter by a Physical Medicine and Rehabilitation professionals (measure unit is cm).
The values of diameter of lymphedema of neck with face
The diameters of upper, middle and lower points of neck and two points of face were measured with tailor meter by a Physical Medicine and Rehabilitation professionals (measure unit is cm). The changes were assessed from baseline neck diameter at end of treatment and after one month.
The values of diameter of lymphedema of neck with face
The diameters of upper, middle and lower points of neck were measured with tailor meter by a Physical Medicine and Rehabilitation professionals (measure unit is cm). The changes were assessed from baseline neck diameter at end of treatment and after one month.
The outcomes of Quality of Life Questionnaire-Head and Neck 35
It was assessed by Quality of Life Questionnaire-Head and Neck 35 that a self questionnaire in head and neck cancer patients. The minimum score is 0 and maximum score is 100. The high scores were worst low scores were good health.
The outcomes of Quality of Life Questionnaire-Head and Neck 35
It was assessed by Quality of Life Questionnaire-Head and Neck 35 that a self questionnaire in head and neck cancer patients. The minimum score is 0 and maximum score is 100. The high scores were worst low scores were good health.
The outcomes of Quality of Life Questionnaire-Head and Neck 35
It was assessed by Quality of Life Questionnaire-Head and Neck 35 that a self questionnaire in head and neck cancer patients. The minimum score is 0 and maximum score is 100. The high scores were worst low scores were good health.
The scores of head and neck external lymphedema rating scale
They were assessed by M. D. Anderson head and neck lymphedema rating scale in head and neck cancer patients. Composite Score ranges from 0 ( low edema) to 3 (high level edema).
The scores of head and neck external lymphedema rating scale
They were assessed by M. D. Anderson head and neck lymphedema rating scale in head and neck cancer patients. Composite Score ranges from 0 ( low edema) to 3 (high level edema).
The scores of head and neck external lymphedema rating scale
They were assessed by M. D. Anderson head and neck lymphedema rating scale in head and neck cancer patients. Composite Score ranges from 0 ( low edema) to 3 (high level edema).
The scores of head and neck external lymphedema rating scale
They were assessed by M. D. Anderson head and neck lymphedema rating scale in head and neck cancer patients. Composite Score ranges from 0 ( low edema) to 3 (high level edema).
The outcomes of Patterson larynx pharynx internal edema scale
It was assessed with Flexible Endoscopic Evaluation Study. Flexible Endoscopic Evaluation Study results were scored on Patterson larynx pharynx edema scale. The scores of scale were no, mild, moderate and severe . The high grade symptom scores were worst, low scores were good health
The outcomes of Patterson larynx pharynx edema scale
It was assessed with Fiberoptic Endoscopic Evaluation Study. Flexible Endoscopic Evaluation Study results were scored on Patterson larynx pharynx edema scale. The scores of scale were no, mild, moderate and severe. The high grade symptom scores were worst, low scores were good health
The outcomes of Patterson larynx pharynx edema scale
It was assessed with Fiberoptic Endoscopic Evaluation Study. Flexible Endoscopic Evaluation Study results were scored on Patterson larynx pharynx edema scale. The scores of scale were no, mild, moderate and severe. The high grade symptom scores were worst, low scores were good health
The outcomes of Patterson larynx pharynx edema scale
It was assessed with Fiberoptic Endoscopic Evaluation Study. Flexible Endoscopic Evaluation Study results were scored on Patterson larynx pharynx edema scale. The scores of scale were no, mild, moderate and severe. The high grade symptom scores were worst, low scores were good health

Secondary Outcome Measures

Mean of demographic
Age, gender, history of smoke, history of morbidities, diagnosis, stage, therapies of cancer, lymphedema stages were noted

Full Information

First Posted
December 26, 2020
Last Updated
July 27, 2021
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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1. Study Identification

Unique Protocol Identification Number
NCT04691310
Brief Title
The Efficacy of Kinesio Taping on Lymphedema Following Head and Neck Cancer Therapy
Official Title
The Efficacy of Kinesio Taping on Neck Lymphedema Following Head and Neck Cancer Therapy: Double Blind Randomized Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 31, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Purpose off the study is investigating to efficacy of kinesio taping on neck lymphedema after the head and neck cancer therapy.
Detailed Description
The neck lymphedema is a multidirectional process that depends on lymphatic circulation issues. The lymphedema can be treated using such as therapies, drugs or surgeries. There are few techniques for treatment of neck lymphedema and also in our best knowledge the kinesio taping therapy on lymphedema following neck cancer therapy had not been investigated or published. The study will assess the efficacy of kinesio taping in neck lymphedema with manual therapy after the head and neck cancer treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Head and Neck Cancer, Kinesio Taping, Therapy
Keywords
Kinesio taping, neck, lymphedema, head, cancer, therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio taping study
Arm Type
Active Comparator
Arm Description
Kinesio tex gold tape was applied to neck localised lymphedema as stretched. Kinesio tape maintained during consecutive days and also were re applied with manual lymphatic drainage therapy as 5 times first week, and afterthat 2 times for 3 weeks (total 4 weeks)
Arm Title
Kinesio taping sham
Arm Type
Sham Comparator
Arm Description
Kinesio tex gold tape was applied to neck localised lymphedema as no-stretched. Kinesio tape maintained during consecutive days and also were re applied with manual lymphatic drainage therapy as 5 times first week, and afterthat 2 times for 3 weeks (total 4 weeks)
Intervention Type
Device
Intervention Name(s)
Kinesio Tex Gold
Intervention Description
The Kinesio Tex Gold is a kinesio tape that had been certified and patented.
Primary Outcome Measure Information:
Title
The values of diameter of lymphedema of neck with face
Description
The diameters of upper, middle and lower points of neck were measured with tailor meter by a Physical Medicine and Rehabilitation professionals (measure unit is cm).
Time Frame
Baseline
Title
The values of diameter of lymphedema of neck with face
Description
The diameters of upper, middle and lower points of neck and two points of face were measured with tailor meter by a Physical Medicine and Rehabilitation professionals (measure unit is cm).
Time Frame
2 weeks
Title
The values of diameter of lymphedema of neck with face
Description
The diameters of upper, middle and lower points of neck and two points of face were measured with tailor meter by a Physical Medicine and Rehabilitation professionals (measure unit is cm). The changes were assessed from baseline neck diameter at end of treatment and after one month.
Time Frame
4 weeks
Title
The values of diameter of lymphedema of neck with face
Description
The diameters of upper, middle and lower points of neck were measured with tailor meter by a Physical Medicine and Rehabilitation professionals (measure unit is cm). The changes were assessed from baseline neck diameter at end of treatment and after one month.
Time Frame
8 weeks
Title
The outcomes of Quality of Life Questionnaire-Head and Neck 35
Description
It was assessed by Quality of Life Questionnaire-Head and Neck 35 that a self questionnaire in head and neck cancer patients. The minimum score is 0 and maximum score is 100. The high scores were worst low scores were good health.
Time Frame
baseline
Title
The outcomes of Quality of Life Questionnaire-Head and Neck 35
Description
It was assessed by Quality of Life Questionnaire-Head and Neck 35 that a self questionnaire in head and neck cancer patients. The minimum score is 0 and maximum score is 100. The high scores were worst low scores were good health.
Time Frame
4 weeks
Title
The outcomes of Quality of Life Questionnaire-Head and Neck 35
Description
It was assessed by Quality of Life Questionnaire-Head and Neck 35 that a self questionnaire in head and neck cancer patients. The minimum score is 0 and maximum score is 100. The high scores were worst low scores were good health.
Time Frame
8 weeks
Title
The scores of head and neck external lymphedema rating scale
Description
They were assessed by M. D. Anderson head and neck lymphedema rating scale in head and neck cancer patients. Composite Score ranges from 0 ( low edema) to 3 (high level edema).
Time Frame
Baseline
Title
The scores of head and neck external lymphedema rating scale
Description
They were assessed by M. D. Anderson head and neck lymphedema rating scale in head and neck cancer patients. Composite Score ranges from 0 ( low edema) to 3 (high level edema).
Time Frame
2 weeks
Title
The scores of head and neck external lymphedema rating scale
Description
They were assessed by M. D. Anderson head and neck lymphedema rating scale in head and neck cancer patients. Composite Score ranges from 0 ( low edema) to 3 (high level edema).
Time Frame
4 weeks
Title
The scores of head and neck external lymphedema rating scale
Description
They were assessed by M. D. Anderson head and neck lymphedema rating scale in head and neck cancer patients. Composite Score ranges from 0 ( low edema) to 3 (high level edema).
Time Frame
8 weeks
Title
The outcomes of Patterson larynx pharynx internal edema scale
Description
It was assessed with Flexible Endoscopic Evaluation Study. Flexible Endoscopic Evaluation Study results were scored on Patterson larynx pharynx edema scale. The scores of scale were no, mild, moderate and severe . The high grade symptom scores were worst, low scores were good health
Time Frame
Baseline
Title
The outcomes of Patterson larynx pharynx edema scale
Description
It was assessed with Fiberoptic Endoscopic Evaluation Study. Flexible Endoscopic Evaluation Study results were scored on Patterson larynx pharynx edema scale. The scores of scale were no, mild, moderate and severe. The high grade symptom scores were worst, low scores were good health
Time Frame
2 weeks
Title
The outcomes of Patterson larynx pharynx edema scale
Description
It was assessed with Fiberoptic Endoscopic Evaluation Study. Flexible Endoscopic Evaluation Study results were scored on Patterson larynx pharynx edema scale. The scores of scale were no, mild, moderate and severe. The high grade symptom scores were worst, low scores were good health
Time Frame
4 weeks
Title
The outcomes of Patterson larynx pharynx edema scale
Description
It was assessed with Fiberoptic Endoscopic Evaluation Study. Flexible Endoscopic Evaluation Study results were scored on Patterson larynx pharynx edema scale. The scores of scale were no, mild, moderate and severe. The high grade symptom scores were worst, low scores were good health
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Mean of demographic
Description
Age, gender, history of smoke, history of morbidities, diagnosis, stage, therapies of cancer, lymphedema stages were noted
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18-70 years External neck lymphedema Head and neck cancer treatment patients patients who have not open wound on neck Patients who were accept to consent form Exclusion Criteria: Mental disorders Cognitive limitations Pregnancy Out of age 18-70 years old Patients who were not accept to consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevgi Atar, Special.,MD
Organizational Affiliation
Prof. Dr. Cemil Tascıoglu City Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Prof Dr Cemil Tascioglu City Hospital
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29308967
Citation
Kasawara KT, Mapa JMR, Ferreira V, Added MAN, Shiwa SR, Carvas N Jr, Batista PA. Effects of Kinesio Taping on breast cancer-related lymphedema: A meta-analysis in clinical trials. Physiother Theory Pract. 2018 May;34(5):337-345. doi: 10.1080/09593985.2017.1419522. Epub 2018 Jan 8.
Results Reference
background
PubMed Identifier
22791550
Citation
Deng J, Murphy BA, Dietrich MS, Wells N, Wallston KA, Sinard RJ, Cmelak AJ, Gilbert J, Ridner SH. Impact of secondary lymphedema after head and neck cancer treatment on symptoms, functional status, and quality of life. Head Neck. 2013 Jul;35(7):1026-35. doi: 10.1002/hed.23084. Epub 2012 Jul 12.
Results Reference
background

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The Efficacy of Kinesio Taping on Lymphedema Following Head and Neck Cancer Therapy

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