Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Breast Neoplasms

Lymphedema

Breast Cancer Lymphedema

Lymphatic Diseases

Postoperative Complications

In group 1, the patients were received standard complex decongestive therapy including skin care, manual lymphatic drainage, multi-layer compression bandaging and exercises. During the treatment, written and verbal information was given to the patients about skin care. Manual lymphatic drainage and compressive bandages were applied by a certified physical therapist. The patients received 30-minutes manual lymphatic drainage involving stationary circular, pumping, scooping, and rotary movements. Multi-layer compression bandaging was applied to the affected limb to promote the flow of excess interstitial fluid out of the extremity using a graded pressure for 22-23 hours in a day. The patients strictly followed a lymphoedema exercise program structured with breathing exercise, neck and shoulder range of motion, and stretching exercise to facilitating lymph resorption.

In group 2, the patients received experimental intermittent pneumatic compression in addition to the standard complex decongestive therapy. The complex decongestive therapy procedure was the same as above, but additionally, 30 minutes of intermittent pneumatic compression was instituted using a pump (Pulse Press Multi 6 Pro; MJS Healthcare Ltd. UK) operating at 30-40 mmHg of pressure. All groups were given a total of 20 treatment sessions, including daily 5 times a week for 4 weeks.

intermittent pneumatic compression

complex decongestive therapy

To evaluate the role of intermittent pneumatic compression in the treatment of breast cancer-related lymphoedema.

Patients with unilateral arm lymphoedema were enrolled and all were hospitalized. The participating patients were randomly divided into two groups.

Demographic features of the patients including age, body mass index \[BMI = weight (kg) / height2 (m2)\], duration of lymphoedema (months) and number of axillary lymph nodes removed were all recorded. The volume (V) of every part of the limb was calculated by the truncated cone formula according to circumferential measurements and the total volume is estimated by the sum of the increments. Circumference measurements were taken at 4-centimetre intervals along the arm from the level of the ulnar styloid to the shoulder with a flexible non-stretch tape measure. The volume between every two circumferential measurement levels was calculated using the following formula:

Volume = h (C2 + Cc + c2) / 12π In this formula, C is the first circumferential measurement (circumference of the top of the cone), c is the second circumferential measurement (circumference of the base of the cone) and h is the height from measurement C to c. Both the affected and non-affected limbs were evaluated by the same examiner. An Excel-based software program was used to convert these values into limb volumes in mL.

The severity of lymphoedema was characterized by the percentage excess volume (PEV) PEV = \[(VLE - VH) / VH\] x 100 where VLE denotes the volume of the lymphoedema arm and VH is that of the healthy arm. PEV is the preferred quantity for defining the severity of lymphoedema than the absolute difference volume. Also, this method minimizes the effects of BMI on the volume estimates. The efficacy of complex decongestive therapy, the response to the therapeutic intervention, was also quantified by the percentage reduction of excess volume (PREV) PREV = \[(pre-treatment VLE - post-treatment VLE) / excess volume)\] x 100. Other assessments of clinical origin were also conducted on the patients by physical therapists who were blind to the applied treatment and the timing of the data collection point. Pitting oedema was evaluated at multiple points on the forearm by pressing the thumb on the region to be investigated for a minute as hard as possible, as such test is considered as an indicator of the presence of excess free fluid accumulated in the superficial interstitial tissue spaces. The Stemmer's sign was performed as an inability to pinch the fold of skin at the base of the finger.

Clinical symptoms of pain (during activity, resting and night), heaviness and tightness in the affected arm were evaluated with Visual Analog Scale (VAS) with a 0-10 numerical rating scale. The patients' functional situation was assessed by the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) outcome questionnaire which is a self-reported assessment tool for the measurement of physical function and symptoms in individuals with a musculoskeletal disorder of the upper limb. This instrument was also reported as a convenient, reliable, and valid patient-reported outcome measure to assess upper extremity disability in patients with breast cancer. The scores indicated the level of disability and severity, ranging from 0 (no disability) to 100 (most severe disability).

Grip strength was measured by using Jamar® hydraulic hand dynamometer (Sammons Preston, Bolingbrook, IL, USA). Both hands of the patient's grip strength were assessed by using the second level of resistant (3.75 cm) as the elbow is at 90º flexion, the forearm is in a neutral position. All measurements were performed bilaterally and three times. The average of the obtained values was recorded in kg. Beck Depression Inventory, a 21-item, self-administered inventory that measures clinical depression, was also administered to the patients. Scores ranged from 0 to 63, and higher scores were indicative of depression. The validity and reliability of the Beck Depression Inventory for the Turkish population have already been tested previously.

Kolmogorov-Smirnov test was used to test whether the data were normally distributed. All of the measured variables failed the normality test and thus median (25-75 percentiles) were given for nonparametric descriptive statistics. Wilcoxon T test was used for the intragroup comparison of the measurements between before and after the treatments. Mann-Whitney U-test was used for the intergroup comparison of the measurements after the treatments. Categorical variables were shown as number (%) and Chi-square tests were used for the comparison of categorical variables. P\<0.05 was accepted as an indicator of the statistically significant difference.

Treatment of Breast Cancer-related Lymphoedema

The Effects of Compression and Massage Therapies in the Treatment of Breast Cancer-related Lymphoedema

The volume of every part of the limb was calculated in liter by the truncated cone formula according to circumferential measurements.

The intensity of pain, heaviness and tightness were measured by visual analog scale (minimum score:0; maximum score:100)(higher values represent worse outcome)

The patients' functional situation was assessed by the Quick Disabilities of the Arm, Shoulder and Hand (Q-DASH) scale. The Q-DASH scores are ranging from 0 (no disability) to 100 (most severe disability).

The measurement of the grip strength in kg was performed by a hydraulic hand dynamometer.

The measurement of the depression was performed by the Beck Depression Inventory scoring.The scale is used to measure intensity and is a self-rating scale scored between 0 and 63. The cut-off point considered is 17. Higher scores reflect more severe depression.

Aydin Adnan Menderes University

Assistant Professor

Breast Diseases

Skin Diseases

(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

Patients with breast cancer related lymphedema

Complex decongestive therapy-phase 1 program consist of meticulous skin and nail care, manuel lymphatic drainage, compression bandages, and remedial exercises. All patients will receive manual lymphatic drainage for three times a week (Monday-Wednesday-Friday) during 4 weeks, 50 minutes a day (a total of 12 sessions) by a trained lymphatic massage therapist.

Complex decongestive therapy phase 1

Esra Giray, MD

Gulseren Akyuz, Prof

Esra Giray

The aim of this study is to evaluate tissue changes via ultrasound after complex decongestive therapy.

Lymphedema can be defined as the abnormal accumulation of protein-rich interstitial fluid that occurs primarily as a consequence of malformation, dysplasia, or acquired disruption of lymphatic circulation. Lymph stasis, which results in peripheral lymphedema, is characterized by edema and adipose tissue proliferation. As a vicious cycle of lymphedema progression, lymph stasis stimulates chronic inflammation because of uncontrolled responses of macrophages and CD4+ (cluster of differentiation 4) cells; fat accumulation also causes chronic inflammation by infiltration and activation of macrophages that produce inflammatory cytokines, which further promote lymph stasis directly or indirectly by decreasing lymphatic pumping and increasing capillary filtration. Lymphedema secondary to breast cancer is caused by the disruption of the lymphatic system, which in the initial stages leads to the accumulation of fluid in the interstitial tissue space and eventually is clinically presented as swelling of the arm, shoulder, neck, or torso. Complex decongestive physical therapy is a widely used nonoperative treatment of breast cancer-related lymphedema. The extremity volume has been one of the major parameters representing the treatment results of complex decongestive physical therapy. However, the increase in extremity volume in lymphedema can be caused both by tissue fluid accumulation and by pathologic tissue proliferation, which cannot be assessed separately at present. Accordingly, the volume or circumference measurement alone may not clarify how these phenomena are modified by complex decongestive physical therapy. Suehiro et al. developed subcutaneous echogenicity grade (SEG) and subcutaneous echo-free space (SEFS) grade via B-mode ultrasonography, allowing semiquantitation of nonspecific subcutaneous tissue inflammation and fluid accumulation. Increase in SEG is attributed to increased cell density and increased collagen content in the tissue and it is considered to indicate the presence of ongoing or previous inflammation in the area. SEFS represents the fluid accumulated in the spaces between superficial fasciae, which is freely mobile in the spaces. Recently, Suehiro et al. have investigated the impact of aggressive decongestion in limbs with lymphedema without SEFS in subcutaneous tissue ultrasonography. According to their results, the impact of aggressive decongestion seemed limited in patients with lymphedema without SEFS. But it was a retrospective study which may be a limitation to draw a firm conclusion. Therefore, the aim of this study is to evaluate tissue changes via ultrasound after complex decongestive therapy.

The physiatrist who perform ultrasonographic assessments will be blind to other assessments.

women with breast cancer related lymphedema

Ultrasonographic Evaluation of Changes After Complex Decongestive Therapy

Evaluation of Tissue Changes Via Ultrasound After Complex Decongestive Therapy Phase I for Breast Cancer Related Lymphedema

The investigators don't plan to share individual participant data (IPD) in public.

Medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle

Medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (\<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS

SEG grade of medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.

Limb volume will be calculated based on truncated cone method from circumference measurements

SEG grade of medial upper arm (MUA): from the medial side of the upper arm to the biceps brachii muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.

Medial upper arm (MUA): from the medial side of the upper arm to the biceps brachii muscle SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (\<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS

Medial upper arm (MUA): from the medial side of the upper arm to the biceps brachii muscle

SEG grade of lateral upper arm (LUA): from the lateral side of the upper arm to the biceps brachii muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.

Lateral upper arm (LUA): from the lateral side of the upper arm to the biceps brachii muscle SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (\<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS

SEG grade of lateral forearm (LFA): from the lateral side of the forearm to the brachioradial muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.

Lateral forearm (LFA): from the lateral side of the forearm to the brachioradial muscle SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (\<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS

Lateral forearm (LFA): from the lateral side of the forearm to the brachioradial muscle

SEG grade of Dorsum of the hand (DH): on the first dorsal interosseous muscle of the hand.

Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.

Dorsum of the hand (DH): on the first dorsal interosseous muscle of the hand. SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (\<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS

Dorsum of the hand (DH): on the first dorsal interosseous muscle of the hand. SEG grade of Dorsum of the hand (DH): on the first dorsal interosseous muscle of the hand.

Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.

SEG grade over wrist Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.

SEFS grade over wrist SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (\<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS

Subcutaneous tissue thickness measurement via ultrasound over wrist

Marmara University

Shock

A Complex decongestive treatment program consisting of manual lymphatic drainage, compression therapy, skin care and remedal exercise will be applied to the patients in this group. Exercise progame includes breathing exercises, joint range of motion exercise, pumping, stretching exercises and aerobic exercises( same with control grup).

In addition, ESWT will be applied as 2 sessions in the first two weeks and 1 session in the 3rd week. In ESWT, 2500 shocks will be applied per session with a frequency of 4 Hz at 2 bar pressure while the patient is in the supine position.

The distribution of this treatment is planned to be 750 shocks to the axillary lymph nodes and 250 shocks to the cubital lymph nodes.

The remaining 1500 shocks will be applied to the arm, forearm, and hand. While determining the dose and duration of ESWT to be applied in the study, it was arranged to be similar to the studies and reviews in the literature.

A Complex decongestive treatment program consisting of manual lymphatic drainage, compression therapy, skin care and remedal exercise will be applied to the patients in this group. Exercise progame includes breathing exercises, joint range of motion exercise, pumping, stretching exercises and aerobic exercises

Extracorporeal Shock Wave Therapy (ESWT); It is a treatment method in which high-intensity pressure waves are applied to the desired point in the body. It has been used in the treatment of kidney stones in previous years, and changes in bone tissue have been observed (12). Today, it is used in musculoskeletal system diseases such as plantar fasciitis, epicondylitis, achiltendinitis, osteoarthritis

Ekstracorporeal Shock Wave Therapy (ESWT)

Complex decongestive therapy consists of manual lymphatic degeneration, compression therapy, skin care and remedal exercise.

Basak Cigdem Karacay, Asst Prof

Basak Cigdem Karacay

Extracorporeal Shock Wave Therapy (ESWT); It is a treatment method in which high-intensity pressure waves are applied to the desired point in the body. It has been used in the treatment of kidney stones in previous years, and changes in bone tissue have been observed . Today, it is used in musculoskeletal diseases such as plantar fasciitis, epicondylitis, achillestendinitis, and osteoarthritis. The main mechanism of action of ESWT is not clearly known, but many studies have shown that it stimulates the early release of angiogenesis-related growth factors such as endothelial nitric oxide synthase (eNOS) and vascular endothelial growth factor (VEGF) and increases blood circulation with induced neovascularization, resulting in cell proliferation and tissue growth. It has been shown to increase regeneration . It has been found to be effective in lymphedema with neovascularization and lymphatic channel synthesis . In the literature, there are studies investigating the additional contributions of complex decongestive therapy combined with ESWT in patients with lymphedema.

Breast cancer is the most common cancer in women and the leading cause of death in the world. With the advances in early diagnosis and treatment methods, the mortality rate in breast cancer tends to decrease . However, some complications secondary to both the disease and the treatment can be seen in patients who have received treatment. Examples of these complications are; functional disability, advanced peripheral neuropathy secondary to chemotherapy agents, pain, weight loss or weight gain, depression, lymphedema. lymphedema; It is primarily a condition characterized by abnormal accumulation of fluid in the subcutaneous tissue and subfascial layer. Lymphedema occurs as a result of fluid accumulation above the lymphatic carrying capacity or insufficient lymphatic transport. Lymphedema is a chronic progressive disease. Therefore, early diagnosis and treatment are important to prevent complications (disability, infection, depression, pain, malignant transformation).

Lymphedema secondary to breast cancer was first defined as postmastectomy lymphedema by Hastead in 1921. Treatment of secondary lymphedema is multidisciplinary. The gold standard method is complex decongestive therapy (CDT). It consists of two phases. Phase 1: lasting 2-6 weeks; manual lymphatic drainage (MLD), multilayer bandaging, exercise and skin care. With MLD treatment, fluid is removed and bandaging is applied to prevent re-accumulation. Exercise and skin care are explained to the patient. When the plateau phase is reached in the measurements, the protection phase is started. Phase 2: includes self-massage, exercise, skin care, bandaging and the use of compression garments. Apart from these; Low-dose laser, oral medications, pneumatic compression devices and surgical methods can be used in the treatment of lymphedema. In this study, both groups will receive MLD treatment. In other words, no group will be left without treatment.

Extracorporeal Shock Wave Therapy (ESWT); It is a treatment method in which high-intensity pressure waves are applied to the desired point in the body. It has been used in the treatment of kidney stones in previous years, and changes in bone tissue have been observed. Today, it is used in musculoskeletal diseases such as plantar fasciitis, epicondylitiS and osteoarthritis. The main mechanism of action of ESWT is not clearly known, but many studies have shown that it stimulates the early release of angiogenesis-related growth factors such as endothelial nitric oxide synthase (eNOS) and vascular endothelial growth factor (VEGF) and increases blood circulation with induced neovascularization, resulting in cell proliferation and tissue growth. It has been shown to increase regeneration . It has been found to be effective in lymphedema with neovascularization and lymphatic channel synthesis . In the literature, there are studies investigating the additional contributions of complex decongestive therapy combined with ESWT in patients with lymphedema. While planning this study, the dose and duration of ESWT were determined based on these studies.

BREAST CANCER-RELATED LYMPHEDEMA ONLY OCCUR IN WOMEN

Effects of Extracorporeal Shock Wave Therapy Added To Complex DecongestiveTherapy In Patıent With Lymphedeme

Effects of Extracorporeal Shock Wave Therapyy Added To Complex DecongestiveTherapy In Patient With Breast Cancer Releated Lymphedema

Evaluation of Pain;

Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.

Both upper extremities of the patient will be measured with the help of a tape measure. The cm difference between both upper extremities will be recorded. Measurements will be made from the MCP (metacarpophalangeal joint), wrist, lateral epicondyle, and 10 cm above and below the lateral epicondyle.

The short version of the Arm, Shoulder and Hand Questionnaire (Quick-DASH) Disability will be used to evaluate the functional status of the patients. Quick-DASH is a self-report questionnaire designed to measure physical function and symptoms in people with upper extremity musculoskeletal conditions.

Measurement of shoulder joint range of motion (ROM) with goniometer is the most frequently used method that provides objective evaluation and error-free measurement in clinical practice. In our study, shoulder ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.

Goarse grip; It is caused by the combined activities of the intrinsic and extrinsic muscles of the hand. In our study, Jamar dynamometer was used for the evaluation of rough grip strength. The digital handheld dynamometer can measure in pounds and kg.

Goarse grip; It is caused by the combined activities of the intrinsic and extrinsic muscles of the hand. In our study, Jamar dynamometer was used for the evaluation of rough grip strength. The digital handheld dynamometer can measure in pounds and kg. .

Kirsehir Ahi Evran Universitesi

Assistant professor

Patients with breast cancer related lymphedema who will undergo complex decongestive therapy

Esra Nur Nur Türkmen, PT

Gulseren Derya Akyuz, Prof

Esra Nur Türkmen, PT

İlker Yagci, Prof

The aim of this study is to investigate and compare responsiveness of current lymphedema assessment scales validated in Turkish.

Lymphedema is defined as the excessive and persistent accumulation of fluid, extracellular proteins, and fat in tissue spaces, caused by inefficiency of the lymphatic drainage system. It is a chronic, progressive condition. Several researchers have investigated the influence on health-related quality of life in upper limb lymphedema after breast cancer treatment using patient reported outcome instruments. Responsiveness of only one of the lymphedema assessment scale, ''Lymphedema Quality of Life Inventory'', has been investigated. Responsiveness of lymphedema assessment scales validated in Turkish has not been examined in detail, thereby limiting their use in clinical trials. Therefore, the aim of this study is to investigate and compare responsiveness of current lymphedema assessment scales validated in Turkish. Patients with breast cancer related lymphedema with International Society of Lymphology-ISL lymphedema stage 2,3 will be included in the study and will receive complex decongestive therapy phase I including meticulous skin and nail care, manuel lymphatic drainage, compression bandages, and remedial exercises. All patients will receive manual lymphatic drainage for three times a week (Monday-Wednesday-Friday) during 4 weeks, 50 minutes a day (a total of 12 sessions) by a trained lymphatic massage therapist. Limb volume will be calculated based on truncated cone method from circumference measurements. Patients will complete Lymphedema Life Impact Scale (LLIS), Patient Benefit Index-Lymphedema(PBI), Lymphedema functioning, disability and health questionnaire(Lymph-ICF), European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer (EORTC-QLQ-30) and Short Form 36 (SF-36) before and after treatment. Changes in limb volumes will be compared in changes in scales after treatment. Responsiveness of the subscales will be will be determined by calculating the effect size (change in all patients), standardized mean response (effect size in a group with improvement), and Guyatt's Responsiveness Index.

Patients with breast cancer related lymphedema who will undergo complex decongestive phase 1

Responsiveness of Outcome Scales in Breast Cancer Related Lymphedema

Investigation and Comparison of Lymphedema Outcome Measurements Validated in Turkish for Assessment of Breast Cancer Related Lymphedema

The LYMQOL-Arm has been developed to assess the impact of lymphedema of the arms on the QoL of the patients. It consists of four domains with 28 items. These domains are symptoms, appearance, function, and mood. The answers were evaluated on a four-point Likert scale (1= not at all 2= a little, 3= quite a bit, 4= a lot). Each item received a score between 1 and 4, with higher scores indicating a worse QoL.

The LLIS is an 18-item measure of physical, psychosocial, and functional impairments caused by lymphedema.

The Patient Benefit Index (PBI) methodology allows for a more direct measurement of patient-relevant treatment.benefit. In the first part the Patient Needs Questionnaire (PNQ)patients rate the importance of a list of patient relevant treatment goals on a five-step scale from "not at all" to "very". In the second part the Patient Benefit Questionnaire (PBQ) patients rate to what extent the treatment goals have been achieved on the same five-step scale. Alternatively, they can choose "does not apply to me" for each treatment goal in both questionnaires. Thus, the patient directly evaluates treatment benefit instead of rating her/his current HRQoL before and after treatment. A PBI weighted global score ranging from 0 (no benefit) to 4 (maximum benefit) is computed for each patient. The weighting algorithm8 ensures that the achievement of important treatment goals will have higher impact on the global score than the achievement of less important goals.

The Patient Benefit Index (PBI) methodology allows for a more direct measurement of patient-relevant treatment.benefit. In the first part the Patient Needs Questionnaire (PNQ) patients rate the importance of a list of patient relevant treatment goals on a five-step scale from "not at all" to "very". In the second part the Patient Benefit Questionnaire (PBQ) patients rate to what extent the treatment goals have been achieved on the same five-step scale. Alternatively, they can choose "does not apply to me" for each treatment goal in both questionnaires. Thus, the patient directly evaluates treatment benefit instead of rating her/his current HRQoL before and after treatment. A PBI weighted global score ranging from 0 (no benefit) to 4 (maximum benefit) is computed for each patient. The weighting algorithm8 ensures that the achievement of important treatment goals will have higher impact on the global score than the achievement of less important goals.

The Lymph-ICF questionnaire is composed of 29 questions. Each question is answered using a visual analog scale (VAS) ranging from 0 to 100 mm. The anchors for the impairments in function (e.g. "Does your arm hurt?") are "not at all" and "very much," and those for the activity limitations and participation restrictions (e.g. "Are you able to carry heavy weights?") are "very well" and "not at all." The Lymph-ICF has 5 domains: physical function, mental function, household activities, mobility activities, and life and social activities. The total score of the Lymph-ICF is equal to the sum of the scores of the questions divided by the total number of answered questions.

The EORTC QLQ-C30 questionnaire is a survey conducted to evaluate the quality of life in patients with breast cancer. It consists of 30 questions which assess symptoms that occurred in the previous two weeks. Responses are given on a Likert scale: 1 - not at all, 2 - a little, 3 - quite a bit, 4 - very much. The global health scale consists of two questions asking patients to classify their general health and quality of life in the previous week, by rating it from 1 to 7, in which 1 means poor and 7, excellent. The questionnaires are divided into three scales: global health scale (GHS), functional scale (FS) and symptom scale (SS).

The Short Form 36 (SF-36) Health Survey measures overall health. It has eight sections: Physical functioning (10), role limitations due to physical health (4), role limitations due to emotional problems (3), energy/fatigue (4), emotional well-being (5), social functioning (2), pain (2), and general health (5). Each scale is transformed into a 0-100 scale on the assumption that each scale carries equal weight. The lower the score, the more disability.

Neoplasms, Second Primary

This application consists of manual lymph drainage, skin care, compression bandage and exercises. This phase will continue for 3 weeks, 5 days a week.

Emine Cihan, PhD

Emine Cihan, pHd

The aim of this study is to investigate the effects of complex decongestive physiotherapy (CDP) on propriseception, balance and sensation in patients with secondary lymphedema that develops in the lower extremities after cancer surgery.

Effects of Complex Decongestive Therapy on Proprioception, Balance and Tactile Sense

Effects of Complex Decongestive Therapy on Proprioception, Balance and Tactile Sense in Lymphedema After Cancer Surgery: A Prospective Randomized Controlled Study

Joint position sense: While the patient lies in the prone position, 15-45-60 degrees of knee flexion will be evaluated in 2 different ways: eyes open and eyes closed. Participants will be asked to find the target angle they have been taught with their eyes closed and will be asked to say "here" in the position where they think they have reached the target angle.

It is performed with one leg supported to evaluate static balance. The eyes will be fixed in the direction of the head and the participant will be asked to close their eyes and will be expected to maintain balance for 30 seconds. It ends when the balance is disrupted. The test will be terminated when the maximum time of 30 seconds expires.

In the application of the test, the participant will be asked to sit in the middle part of a 43.18 cm (12 inches) high chair with his back upright, his feet on the ground and his arms crossed in front of his body. While in this position, the test started with the "start" command and the participant will be asked to stand up and sit down as fully as he can for 30 seconds. Standing upright once will count as 1, and the number of times he stands upright during 30 seconds will constitute the participant's score

It is evaluated with Semmes Weinstein Monofilaments (SWM). The test will be performed with the patient lying in the supine position. In practice, the areas to be tested will be determined as the 1st metatarsal and 5th metatarsal heads and the midpoint of the heel. Values between 1.65-2.83 (green) are considered normal sensation. Values between 3.22-3.61 (blue) are reduced light touch, values between 3.84-4.31 (purple) are reduced protective sensation, values between 4.56-6.65 (red) are loss of protective sensation and 6, If there is no response to 65, it is considered deep pressure perception.

Participants will be evaluated in a sitting position with eyes closed using an aesthesiometer (Instrument Company, Lafayette, IN, USA). The evaluation will be made from the trans-metatarsal area, the middle of the foot and the middle of the heel. It will start from the range where the two points can be easily distinguished. The shortest length felt between two points will give the static two-point discrimination value.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment of Breast Cancer-related Lymphoedema	NCT03992508	Lymphedema	intermittent pn... complex deconge...	-	Aydin Adnan Menderes University
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
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
Ultrasonographic Evaluation of Changes After Complex Decongestive Therapy	NCT04139291	Lymphedema of U...	Complex deconge...	18 Years - 75 Years	Marmara University
Effects of Extracorporeal Shock Wave Therapy Added To Complex DecongestiveTherapy In Patıent With Lymphedeme	NCT05297643	Lymphedema, Bre...	Ekstracorporeal... complex deconge...	18 Years - 65 Years	Kirsehir Ahi Evran Universitesi
Responsiveness of Outcome Scales in Breast Cancer Related Lymphedema	NCT04138667	Lymphedema of U...	complex deconge...	18 Years - 80 Years	Marmara University
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
Responsiveness of Outcome Scales in Breast Cancer Related Lymphedema	NCT04138667	Lymphedema of U...	complex deconge...	18 Years - 80 Years	Marmara University
Effects of Complex Decongestive Therapy on Proprioception, Balance and Tactile Sense	NCT06204510	Lymphedema of L... Sensitisation Balanced Therapy-Associa...	complex deconge...	18 Years - 65 Years	Selcuk University
Effects of Extracorporeal Shock Wave Therapy Added To Complex DecongestiveTherapy In Patıent With Lymphedeme	NCT05297643	Lymphedema, Bre...	Ekstracorporeal... complex deconge...	18 Years - 65 Years	Kirsehir Ahi Evran Universitesi

Spots Global Cancer Trial Database for complex decongestive therapy