Clinical trial NCT05483569: Diaphragmatic Exercises and Fascial Release Techniques on the Treatment of Lower Extremity Lymphedema
Official title: The Effect of Multidimensional Diaphragmatic Breathing Exercises and Fascial Release Techniques on the Treatment of Lower Extremity Lymphedema Caused by Gynecological Cancer Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Extremity Lymphedema
Keywords: Lower Extremity Lymphedema
Diaphragmatic Breathing Exercises
Fascial Release Techniques
Gynecological Cancer Treatment
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups in this study. Each group will consist of 15 women aged 25-65 years with Lower Extremity Lymphedema Caused by Gynecological Cancer Treatment. A total of 30 participants will take part in the study. CDP program and placebo fascial release techniques will be applied to the participants in Group 1 and, in addition to the CDP program, the participants in Group 2 will be given multidimensional diaphragmatic breathing exercises and fascial release techniques will be applied.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effect of multidimensional breathing exercises and fascial release techniques performed in addition to the conventional treatment program on the treatment of lymphatic fluid in women with lower extremity lymphedema due to gynecological cancer treatment, and the reflection of these practices on the functional level, sleep and quality of life.

Detailed description: Secondary lower extremity lymphedema is frequently encountered after gynecological (endometrial, cervical, ovarian, vulvar/vaginal) cancer treatments. Lymphedema is a non-curative disease that is characterized by fluid and protein accumulation in the subcutaneous space. In the later stages, secondary skin changes and ulcers accompany, but it can cause complications such as fatigue, decrease in physical activity level, sleep and sexual dysfunction, and decrease in quality of life. Depending on the damaged area of the lymphatic system, it is exposed unilaterally or bilaterally, and in some cases, it also covers the lower body quarter and genital area. Chemotherapy and radiotherapy applications are a factor in its emergence. However, it has been reported that the main cause of lymphedema associated with gynecological cancer is the intervention in abdominal lymph nodes (para-aortic/-caval/external iliac/obturator/internal iliac/common iliac/presacral) and inguinal lymph nodes, especially pelvic. Studies have shown that lymph node interventions disrupt lymphatic flow and the risk of lymphedema exposure increases in direct proportion to the number of lymph nodes removed.

The superficial lymphatic drainage of the lower extremity occurs through lymphatic collectors, mainly to the inguinal and to a lesser extent, to the popliteal region lymph nodes. Lymph fluid passing through the deep lymphatic system from these regions, follows the pelvic lymph nodes, lumbar lymph nodes, lumbar trunks, cisterna chyli, and ductus thoracicus, respectively, and discharges into the venous system from the left venous aspect. Because of its passage through the abdominal and thoracic cavities, lower extremity lymphatic drainage is affected by thoracolumbal diaphragmatic motility. It has been reported that diaphragmatic movement creates positive pressure in the abdominal region during inspiration, providing the filling of lymph collectors/nodules (also venous system) in this region. On the other hand, negative pressure in the thoracic region during expiration results in a vacuum effect that accelerates the flow in the lend nodule and collectors towards the venous angle in both the thoracic and abdominal regions. The fact that approximately 60% of the lymph nodes in the body are below the diaphragm and the presence of a unique lymphatic drainage area on the peritoneal surface of the diaphragm shows how high the contribution of diaphragmatic movement to lymphatic drainage is.

Effectively fulfilling the function of the diaphragm (respiratory and veno-lymphatic drainage); It has been reported that it depends on the position and range of motion of the diaphragm. The position of the diaphragm is defined by the Zone of Apposition (ZOA) (the distance between the insertion of the diaphragm and its apex).

The shorter/longer than normal length of this area, which normally represents 30% of the total costal surface, is defined as the "suboptimal position". Suboptimal position indicates that the movement of the diaphragm is not optimal. Among the factors that cause suboptimal position of ZOA, somatic disorders and impaired posture are shown in the first place. In addition, it has been reported that the diaphragm is associated with many structures in the abdominal region via the fascia, and the fascial mobility of the abdominal region affects the position and movement of the diaphragm. In addition, it has been reported that the pelvic floor (pelvic diaphragm) opens in parallel with the movement of the thoracolumbal diaphragm, playing a role in controlling the intra-abdominal pressure during inspiration and contributing to the expansion of the limits of the mobility of the diaphragm. All these factors suggest that they may be associated with normalizing the mobility of the abdominal fascia and pelvic diaphragm in order to optimize the position and mobility of the diaphragm, thereby maximizing its function.

Lymphedema treatment is generally performed with Complex Decongestive Physiotherapy (CDP), which is offered as the most valid method by the International Society of Lymphology (ISL) and consists of manual lymph drainage (MLD), skin care, multi-layer bandage application and exercise. In manual lymph drainage, the fluid in the lymphedema area is sent to the nearest healthy absorption areas by using anastomosis routes. Although breathing exercises are performed in the exercise section of the CDP, multidimensional breathing exercises and fascia release applications to optimize the movement of the diaphragm (increasing the movement of the diaphragm, abdominal fascia and pelvic diaphragm) are not used. Investigators think that increasing the working performance of healthy collectors and nodules with applications that optimize the position and mobility of the diaphragm (which may be impaired due to surgical interventions and/or radiotherapy applications) will support impaired thoraco-abdominal lymphatic flow due to interventions for gynecological cancer (radiotherapy and lymph node dissection). The aim of this study is to investigate the effect of multidimensional diaphragmatic breathing exercises and abdominal fascial release techniques on the treatment of lower extremity lymphedema.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 25-65
* Having unilateral lower extremity lymphedema (including/not including the trunk) due to gynecological cancer diagnosis and treatment method.
* Having Stage 1 and 2 lymphedema according to the International Society of Lymphology (ISL) classification
* Having situation that prevents the application of manual lymph drainage (cardiac edema, acute deep vein thrombus, acute renal failure, acute pulmonary edema, etc.)
* Having a condition that prevents pressure application (arterial insufficiency, pressure intolerance, etc.)
* Not having received conservative treatment for lymphedema for at least 6 months

Exclusion Criteria:

* Having history of metastases
* Having radiogenic fibrosis in the abdomino-pelvic region
* Having additional orthopedic (scoliosis, etc.), neurological (multiple sclerosis, stroke, etc.) and rheumatological diseases (ankylosing spondylitis, rheumatoid arthritis, etc.) that will affect lower extremity functions
* Having connective tissue disease that will affect tissue properties
* Having diseases (cardiac edema, peripheral artery disease, etc.) that prevent MLD and/or bandage application
* Continuation of Radiotherapy (Must have ended at least 3 months ago) and Chemotherapy applications
* Using sedatives and/or muscle relaxants that may alter muscle tone.
* Having any surgical intervention for lymphedema
* Being diagnosed with obesity (BMI\>30)

Primary outcomes:
measure: Data Record
timeFrame: Baseline
measure: Leg circumference measurement
timeFrame: Change from baseline leg circumference measurement at week 3 and week 7.
measure: Functional Evaluation
timeFrame: Change from baseline Lower Extremity Functional Scale at week 3 and week 7.
measure: Evaluation of Sleep Quality
timeFrame: Change from baseline Pittsburgh Sleep Quality Index at week 3 and week 7.
measure: Evaluation of Quality of Life
timeFrame: Change from baseline Lymphedema Quality of Life Questionnaire at week 3 and week 7.
measure: Passive Tone
timeFrame: Change from baseline passive tone of myofascial tissues at week 3 and week 7.
measure: Stiffness
timeFrame: Change from baseline Stiffness of myofascial tissues at week 3 and week 7.
measure: Decrement
timeFrame: Change from baseline Decrement of myofascial tissues at week 3 and week 7.
measure: Creep
timeFrame: Change from baseline Creep of myofascial tissues at week 3 and week 7.
measure: Relaxation time
timeFrame: Change from baseline Relaxation time of myofascial tissues at week 3 and week 7.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
Study officials:
affiliation: Istanbul Medeniyet University
name: Nilüfer Kablan, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yoshihara M, Shimono R, Tsuru S, Kitamura K, Sakuda H, Oguchi H, Hirota A. Risk factors for late-onset lower limb lymphedema after gynecological cancer treatment: A multi-institutional retrospective study. Eur J Surg Oncol. 2020 Jul;46(7):1334-1338. doi: 10.1016/j.ejso.2020.01.033. Epub 2020 Jan 31.
citation: Borman P, Yaman A, Denizli M, Karahan S. The Reliability and Validity of Lymphedema Quality of Life Questionnaire-Leg in Turkish Patients with Lower Limb Lymphedema. Lymphat Res Biol. 2020 Feb;18(1):42-48. doi: 10.1089/lrb.2018.0048. Epub 2019 May 24.
citation: Hruby RJ, Martinez ES. The Lymphatic System: An Osteopathic Review. Cureus. 2021 Jul 17;13(7):e16448. doi: 10.7759/cureus.16448. eCollection 2021 Jul.