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

Head and Neck Cancer Clinical Trial

Official title:

The Efficacy of Kinesio Taping on Neck Lymphedema Following Head and Neck Cancer Therapy: Double Blind Randomized Placebo Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691310
• Other study ID #: 309, 2020-082
• Status: Completed
• Phase: N/A
• Start date: December 31, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: July 2021
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Kinesio Taping
• Lymphedema
• Therapy

Intervention

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

Locations

Country	Name	City	State
Turkey	Prof Dr Cemil Tascioglu City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Mean of demographic	Age, gender, history of smoke, history of morbidities, diagnosis, stage, therapies of cancer, lymphedema stages were noted	Baseline