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Complex Physical Therapy plus Pressotherapy during three weeks

Complex Physical Therapy plus Pressotherapy

Kinesio Taping

Violeta Pajero Otero, MRes

This crossover study compares two different treatment techniques for Breast Cancer-Related Lymphedema: 1. Complex Physical Therapy plus Pressotherapy.

2. Kinesio Taping.

Breast Cancer-Related Lymphedema (BCRL) tends to progress in stage and grade if it is not treated.

Complex Physical Therapy (CPT), that includes Manual Lymph Drainage + Multilayer Bandage + Self-care, is the most used technique in order to join the benefits of each technique by the lack of great results with only one technique. The most volume reduction found in a study was achieved combining CPT and Pressotherapy(P). On the other hand, the use of Kinesio Taping (KT) for BCRL has been spreading lately although its clinical efficacy has not been determined by high quality studies.

GOALS:

Main objective: To analyze the effectiveness in the reduction of BCRL volume with KT versus CPT+P in patients attended at the rehabilitation service at HU12Octubre.

Secondary objectives:

To analyze possible changes after each therapy in:

* DASH (Disability Arm, Shoulder and Hand) outcome measure score.
* TTDL (textile therapeutic device for lymphedema) questionnaire score (a quality of life questionnaire for patients with breast cancer-related upper lymb lymphedema using textile therapeutic device that has been validated previously).
* Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using visual analogue scale (VAS).
* Goniometry of Upper Limb.

METHODOLOGY OF THE STUDY:

Design: crossover trial, with a 3-month washout period between both treatment phases. Open design: it is impossible during the treatment to blind physiotherapists and patients, due to the observable differences between both therapies neither during their application nor in the hours after their removal, by the marks left in the skin. The statistical analysis will be supervised by staff of the Clinical Research Unit-Clinical Trials (i+12) of HU12Octubre with the variables coded to blind the analyst.

Interventions: The two therapies compared are:

* CPT+ P.
* KT. Sample size: a sample of 50 patients (25 in each group) was calculated. Subjects of study and randomization: An initial computerized randomized sample was generated among the patients who had attended the Breast Pathology Rehabilitation visit at HU12Octubre during the previous year and who met the eligibility criteria and they were randomly assigned to the groups.

3-month previous washout period; 3-week treatment phases; 3-month washout period between both treatment phases.

Open design: it is impossible during the treatment to blind the physiotherapists and patients, due to the observable differences between both therapies both during their application and in the hours after their removal, by the marks that leave in the skin.

Interventions: The two therapies compared are:

* CPT+ P.
* KT.

The statistical analysis will be supervised by staff of the Scientific Support Unit: Epidemiology and Biostatistics (i+12), Hospital Universitario 12 de Octubre with the variables coded to blind the analyst.

Comparison of Techniques for Breast Cancer-Related Lymphedema.

Complex Physical Therapy Plus Pressotherapy Versus Kinesio Taping in Breast Cancer-Related Lymphedema. Randomized Crossover Trial.

Time since axillary surgery in years at the beginning of the study.

Lymphadenectomy or Sentinel Lymph Node Biopsy.

Truncated Cone Formula for Volume from upper limb circumference.

Validated questionnaire about Disability of the Arm,Shoulder and Hand.

a quality of life questionnaire for patients with breast cancer-related upper lymphedema using textile therapeutic device validated previously (not yet published).

The weight in kilograms divided by the square of the height in metres (kg/m2).

Hospital Universitario 12 de Octubre

University of Castilla-La Mancha

Violeta Pajero Otero

Physiotherapist at the Mammary Pathology Unit

(n=20) received complex decongestive therapy only

(n=20) received cryotherapy and complex decongestive therapy

(n=20) received kinesio taping and complex decongestive therapy

1. Manual lymphatic drainage (MLD).
2. Compression bandage.
3. Exercises to enhance lymphatic drainage.
4. Skin care.

Complex decongestive therapy

It is a mature and safe-to-use system that cools the air to -32°C. Steps of application included: 1) Apply oil or cream to moisture the skin before cryotherapy application; 2) Initialize the mini cryo-air equipment at level 6.

Cryotherapy

It is a new choice in the field of physical therapy. The material used for the KT and the original concept of the taping technique were introduced by Dr Kenso Kase in 1973.

Kinesio taping

Ragaee Mahmoud

Reham Mahmoud

Reham Saeed, Doctora

Rabab Saeed, Doctora

To examine the efficacy of complex decongestive therapy (CDT), cryotherapy and kinesio taping (KT) in patients with post-mastectomy lymphedema

Sixty women diagnosed clinically by physician as post-mastectomy lymphedema, suffered from grade 2 and 3 lymphedema based on clinical investigations and their ages between 40 and 60 years were randomly assigned in single pre - post measurement study. They divided randomly into three groups of equal size (A, B \& C). The three groups received CDT program, group (A) (n=20) received CDT only, group (B) (n=20) received cryotherapy and group (C) (n=20) received KT

Effect of Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema: A Randomized Control Trial

Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema

It is a valid and reliable method, its protocol was used throughout, with measures performed on both arms at the axilla, halfway from the axilla to the cubital fossa, cubital fossa, halfway from the cubital fossa to the wrist, and at the wrist.

It consisted of a line, often 10 cm long (100 mm); its ends are generally labelled with verbal pain anchors (e.g., "no pain" and "pain as bad as it could be")

It is widely validated and popularly method that is used to evaluate QOL of the patients. Since then, the reliability and validity of the SF-36 questionnaire have been evaluated in a number of specific population world-wide

It is GONIO_PLASTIC_360, China, frequently used for measurement of shoulder ROM (flexion, abduction and external rotation) by physical therapists to assess ROM due to its ease of use, portability, noninvasive nature, and low cost

South Valley University

Lecturer

It was done a four week phase with Kinesio Taping in the arm affected with lymphedema.

It was done a four week phase with Compression garment in the arm affected with lymphedema.

Compression Garment

Breast cancer-related lymphedema (BCRL) tends to become chronic and progressive. Current therapies have modest results for this condition. Compression garments (CG) prevent the worsening of lymphedema and even improve it, during periods between treatments of physical therapy. Kinesio Taping(KT) is being recently used for lymphedema, although little evidence backs it. The aim of this study is to compare the reduction of lymphedema volume with both therapies.

Primary end points: to evaluate whether the decrease in BCRL volume is different for a 4-week treatment with KT than with CG.

Research design:

Randomized quasi-experimental clinical pilot study: initial sample randomly balanced into two groups . The initial sample was selected among the patients of "Breast Pathology Rehabilitation" at Hospital Universitario 12 de Octubre . The planned sample size was 30.

Cross Design: it made possible to evaluate two different treatments in the same patient, cancelling intragroup variability.

Open design: it was impossible to blind patients and physiotherapist researcher because of patent visual differences between the two therapies, CG or KT, both during application and while being worn, and even in the hours after its removal, due to the marks left on the skin. However, at least one external evaluator suitably trained was implemented and performed the randomisation of the groups and collected all patient data. Statistical study was also made by others (staff of the "Clinique Investigation Unit (i+12)" of Hospital Universitario 12 de Octubre) with coded variables to blind the analyst.

Two treatmet phases, with a four week wash out period bewtween them:

* A four week phase with Kinesio Taping
* A four week phase with compression garments.

Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

Kinesio Taping Versus Compression Garments in the Treatment of Breast Cancer-Related Lymphedema. Randomized Crossover Trial.

Goniometry of shoulder, elbow, wrist and hand.

Head and Neck Neoplasms

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)

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

Kinesio Tex Gold

Sevgi Atar, Special.,MD

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

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.

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

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

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 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 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 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.

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.

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).

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

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

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

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Medical Doctor

Musculoskeletal Diseases

Nervous System Diseases

Wounds and Injuries

Syndrome

Myalgia

Pain

Carpal Tunnel Syndrome

Arthralgia

Muscular Diseases

Neuromuscular Diseases

Musculoskeletal Pain

Neurologic Manifestations

All Drugs and Chemicals

Hormones

Estrogens

Aromatase Inhibitors

The first group will receive a decalogue of healthy tips (general, to lead an active life) based on the best available evidence, and several strips of neuromuscular bandage will be applied on areas that refer pain (cervical, lumbosacral, both or wrist-forearm).

Neuromuscular taping

Antonio I Cuesta-Vargas, PhD

Inmaculada Conejo-Tirado

Background: It has been demonstrated that aromatase inhibitors (AIs) are more effective than tamoxifen in reducing breast cancer recurrence. However, despite the excellent results, the side effects associated with them cause between 24.5 and 31.3% therapy abandon. This study aimed to verify the effectiveness of Neuromuscular Taping (NMT) in the treatment of myalgia and arthralgia induced by AIs in women who have had breast cancer. Our goal is to improve their pain, decreasing by 20% the values of their Visual Analogue Scale (VAS) at various points in order to improve symptoms and increase adherence.

Methods/Design: The study includes 156 breast cancer survivors treated with endocrine therapy (aromatase inhibitors or tamoxifen and aromatase inhibitors) from Virgen de la Victoria Hospital (Málaga, Spain) and musculoskeletal disorders resulting from such treatment. Clinical and patient data were obtained from medical histories, genetic and proteomic analysis, grip strength and algometry measured, questionnaires and the outcome of interest, their VAS. NMT is applied in four possible locations, according to the symptoms of each participant: carpal tunnel, cervical, lumbar or lumbar and cervical. There are several more interventions before repeating the readings from the last five weeks of the start of the study.

Effect of Kinesiotaping for the Treatment of Hormone-induced Myalgia in Women Given Breast Cancer Survivors

Effect of Kinesiotaping for the Treatment of Hormone-induced Myalgia in Women: Randomised Controlled Trial

A record will be kept of some medical data such as tumor grade, types carried, complementary treatments and end date, and the type of hormone therapy received and start date. The possible presence of comorbidities will also be collected.

Genetic determinants. Analyze genetic determinants due to the importance of genetic background on AIA and abandonment of therapy (Garcia-Giralt N., 2013). Estrogen receptor 1 (ESR1), aromatase (CYP19A1) and steroid, 17-alpha-hydroxylase / 17,20 lyase (CYP17A1) (Garcia-Giralt N., 2013), (Henry NL, 2012) and (Mao JJ, 2011) have been selected as candidate genes.

Samples for extracting genes will be collected in both cases with controls on the baseline and the end of it. The DNA is extracted from whole blood using the DNA Blood Maxi Qiafilter (Qiagen, Inc., Valencia, CA) (Henry NL, 2013) kit.

This questionnaire will contain information on the following variables: gender and date of birth, marital status... Add basic anthropometric data such as weight, height, BMI, waist circumference and hip.

For our analysis investigators use four plasma proteins: serum amyloid A, collectin, immunoglobulin G (IgG) light chain kappa and add C1Q (Minton O., 2013).

The pain threshold pressure is defined as the minimum amount of pressure with which an initial feeling of pressure switches to pain. (Vanderweeën L. 1996). PPT measurements were performed on:

* Cervical Musculature in space interapofisario C5-C6.
* Lumbosacral Musculature: an L4 level on the erector spinae muscle.
* Median nerve as it passes through the carpal bones.

This instrument will be used to measure grip strength of both upper limbs. This test of strength has been previously used to measure the loss of strength in breast cancer survivors (Kaya T, 2010), even in cases where patients were treated with IAs (Lintermans A., 2011) . The dynamometer has proven to be the safest \[ICC = 0.98\] and most valid \[ICC = 0.99\] method to measure grip strength of the hand. (Bellace JV, 2000).

This is a scale to measure the profile of mood states. It consists of 65 items with five possible answers. The questionnaire delivered to patients is frequently used for study of breast cancer survivors (Cantarero-Villanueva, 2011). The reliability of the Spanish version of the POMS is high (Cronbach's α ranging from .76 to 0.91).

Tool used to determine the degree of perception that cancer patients have of their feelings of fatigue and how it alters their quality of life.

This short version of the questionnaire proved to be adequate, with values of Kaiser-Meyer-Oklin (0.89) and Bartlett's sphericity test (P \<0.001) index. The goodness of fit indices of confirmatory factor analysis are (normed fit index = 0.91 and = 0.92 comparative rate setting) satisfactory. The test-retest reliability of this questionnaire is very good (r = 0.947, P \<0.001). (AI Cuesta-Vargas, 2013).

This is a specific questionnaire for cancer, "core", created by the EORTC Group. It consists of 30 items to assess HRQOL and physical, emotional, social status and overall functioning of patients diagnosed with cancer. The questions refer to the last week from the date on which the respondent completed the form. It is organised in several multi-item scales and some independent items. The reliability of the QLQ-C30 is adequate, with Cronbach Alpha values between 0.52 and 0.89 in different scales. (Moro D.,2011)

The Visual Analogue Scale (VAS) was designed to allow a subjective assessment of pain. A VAS is usually a horizontal line of 10 cm. with perpendicular lines at the ends, which are defined as the extreme limits of the painful experience. Previous studies have shown that the VAS has adequate psychometric properties, including test-retest reliability (r = 0.78) and convergent validity with other measures of pain such as the McGill Pain Questionnaire (r = 0.49 to 0.65) (Sriwatanakul K ., 1983).

For this study we will use the Spanish version (SFI-Sp), since it has proven to be a valid and reliable measure of the spinal region result. This regional tool reflects the status and any change in the kinetic chain of the spine. This questionnaire has demonstrated high internal consistency (α = 0.85) and reliability (r = 0.96) (AI Cuesta-Vargas, 2014).

This study uses the Spanish version (ULFI-Sp). This questionnaire has demonstrated high internal consistency (α = 0.94) and reliability (r = 0.93), making it a very useful tool for the evaluation of patients with disorders of the upper limbs, in both the clinical and research fields (AI Cuesta-Vargas, 2013).

This Index includes a score for five movements of the trunk upright that result in Back Pain Index (BAI) and a record of "Morning Stiffness in the Back" (MBS). The sum of the BAI and MBS gives the BADIX (max. 20 points) (Kovacs FM, 2002).

The BADIX appears to be a valid and reliable tool for the evaluation of morning stiffness restricting the mobility of the back, and discriminates whether the result of a treatment has been successful or not. (Farasyn A., 2013).

This new Back Pain Disability index seems reliable (test-retest after 3 days) and is valid in the case of significant clinical change; it has also been shown to have discriminatory power and effect size comparable to other indices in assessing disability of patients with low back pain sensitivity. (Farasyn A., 2013).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Techniques for Breast Cancer-Related Lymphedema.	NCT03051750	Breast Cancer L...	Complex Physica... Kinesio Taping	18 Years -	Hospital Universitario 12 de Octubre
Comparison of Techniques for Breast Cancer-Related Lymphedema.	NCT03051750	Breast Cancer L...	Complex Physica... Kinesio Taping	18 Years -	Hospital Universitario 12 de Octubre
Effect of Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema: A Randomized Control Trial	NCT06327438	Breast Neoplasm...	Complex deconge... Cryotherapy Kinesio taping	40 Years - 60 Years	South Valley University
Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema	NCT03051776	Breast Cancer L...	Kinesio Taping Compression Gar...	18 Years -	Hospital Universitario 12 de Octubre
Effect of Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema: A Randomized Control Trial	NCT06327438	Breast Neoplasm...	Complex deconge... Cryotherapy Kinesio taping	40 Years - 60 Years	South Valley University
The Efficacy of Kinesio Taping on Lymphedema Following Head and Neck Cancer Therapy	NCT04691310	Lymphedema Head and Neck C... Kinesio Taping Therapy	Kinesio Tex Gol...	18 Years - 70 Years	Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Effect of Kinesiotaping for the Treatment of Hormone-induced Myalgia in Women Given Breast Cancer Survivors	NCT02406794	Breast Neoplasm...	Neuromuscular t...	18 Years -	University of Malaga
Effect of Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema: A Randomized Control Trial	NCT06327438	Breast Neoplasm...	Complex deconge... Cryotherapy Kinesio taping	40 Years - 60 Years	South Valley University

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