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

Study Overview
=================
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.

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

Conditions
-----------------
Lymphedema, Head and Neck Cancer, Kinesio Taping, Therapy

Intervention / Treatment
-----------------
* Device: Kinesio Tex Gold


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kinesio taping study<br>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<br>* The Kinesio Tex Gold is a kinesio tape that had been certified and patented.<br>|
| Sham Comparator: Kinesio taping sham<br>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<br>* The Kinesio Tex Gold is a kinesio tape that had been certified and patented.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of demographic | Age, gender, history of smoke, history of morbidities, diagnosis, stage, therapies of cancer, lymphedema stages were noted | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kinesio taping, neck, lymphedema, head, cancer, therapy