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

NCT04691310 | Completed FDA Device

• 1 other identifier: 309, 2020-082
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose off the study is investigating to efficacy of kinesio taping on neck lymphedema after the head and neck cancer therapy.

Conditions

Lymphedema; Head and Neck Cancer; Kinesio Taping; Therapy

Keywords

Kinesio taping; neck; lymphedema; head; cancer; therapy

Outcome Measures

Primary Outcomes (15)

• 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).

  Baseline

• 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).

  2 weeks

• 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.

  4 weeks

• 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.

  8 weeks

• 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.

  baseline

• 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.

  4 weeks

• 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.

  8 weeks

• 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).

  Baseline

• 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).

  2 weeks

• 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).

  4 weeks

• 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).

  8 weeks

• 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

  Baseline

• 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

  2 weeks

• 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

  4 weeks

• 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

  8 weeks

Secondary Outcomes (1)

• Mean of demographic

  Baseline

Study Arms (2)

Kinesio taping study

ACTIVE COMPARATOR

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)

Device: Kinesio Tex Gold

Kinesio taping sham

SHAM COMPARATOR

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)

Device: Kinesio Tex Gold

Interventions

Kinesio Tex Gold DEVICE

The Kinesio Tex Gold is a kinesio tape that had been certified and patented.

Kinesio taping sham; Kinesio taping study

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Prof Dr Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 29308967 BACKGROUND

• 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.

  PMID: 22791550 BACKGROUND

MeSH Terms

Conditions

Lymphedema; Head and Neck Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site

Study Officials

• Sevgi Atar, Special.,MD

  Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 26, 2020
• First Posted: December 31, 2020
• Study Start: December 31, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)