Trial Title:
Diaphragmatic Exercises and Fascial Release Techniques on the Treatment of Lower Extremity Lymphedema
NCT ID:
NCT05483569
Condition:
Lower Extremity Lymphedema
Conditions: Official terms:
Lymphedema
Conditions: Keywords:
Lower Extremity Lymphedema
Diaphragmatic Breathing Exercises
Fascial Release Techniques
Gynecological Cancer Treatment
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Single (Outcomes Assessor)
Masking description:
Participants will be divided into two groups using the block randomization method.
Participants will be randomly distributed into 2 blocks of 15 participants. Each group
using random number generation technique by computer. All evaluations will be made by the
researcher who did not participate in the study.
Intervention:
Intervention type:
Other
Intervention name:
Complex Decongestive Physiotherapy
Description:
Complete or complex decongestive physiotherapy (CDP) is a treatment for lymphedema, a
condition in which excess fluid (lymph) collects in a part of the body. Damage to the
lymph nodes or vessels, or a blockage leading to chronic swelling, usually causes
lymphedema.
Arm group label:
Complex Decongestive Physiotherapy
Intervention type:
Other
Intervention name:
Multidimensional Diaphragmatic Breathing Exercises
Description:
Diaphragmatic breathing is an exercising technique to help strengthen your diaphragm and
fill your lungs with air more efficiently.
Arm group label:
Multidimensional Diaphragmatic Breathing Exercises and Facial Release Technique
Intervention type:
Other
Intervention name:
Facial Release Technique
Description:
Fascial release is a manual therapy method that is applied holistically to the muscles
and surrounding fascia through mechanical stimulation. It is a comprehensive approach to
the evaluation and treatment of the muscular and fascia system in the body.
Arm group label:
Multidimensional Diaphragmatic Breathing Exercises and Facial Release Technique
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.
Criteria for 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)
Gender:
Female
Minimum age:
25 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Istanbul Medeniyet University
Address:
City:
Istanbul
Zip:
34862
Country:
Turkey
Start date:
September 1, 2022
Completion date:
September 1, 2023
Lead sponsor:
Agency:
Istanbul Medeniyet University
Agency class:
Other
Source:
Istanbul Medeniyet University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05483569