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Clinical Trials/NCT05297643
NCT05297643
Recruiting
Not Applicable

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

Kirsehir Ahi Evran Universitesi1 site in 1 country44 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lymphedema, Breast Cancer
Sponsor
Kirsehir Ahi Evran Universitesi
Enrollment
44
Locations
1
Primary Endpoint
Environmental Measurement;
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
January 15, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Kirsehir Ahi Evran Universitesi
Responsible Party
Principal Investigator
Principal Investigator

Basak Cigdem Karacay

Assistant professor

Kirsehir Ahi Evran Universitesi

Eligibility Criteria

Inclusion Criteria

  • Be over 18 years old
  • History of lymphedema for at least 6 months after breast cancer treatment
  • Ending radiotherapy treatment at least 2 months ago
  • Not being included in the Complex DecongestiveTherapy program within 3 months
  • Having unilateral lymphedema
  • Having stage 2 lymphedema
  • Signing of the voluntary consent form
  • Patients who have undergone oncological follow-up for breast cancer in the last 6 months and have been shown to be free of recurrence and metastasis

Exclusion Criteria

  • Active cancer
  • Skin infection, radiotherapy burn
  • Severely affected upper extremity range of motion 4 kidney failure
  • Heart failure
  • History of untreated deep venous thrombosis
  • Body mass index I≥35 kg/m2
  • Using a pacemaker/internal defibrillator
  • Patients continuing radiotherapy and/or chemotherapy treatment
  • Having bilateral lymphedema

Outcomes

Primary Outcomes

Environmental Measurement;

Time Frame: 12th week

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.

Evaluation of Pain;

Time Frame: 12th week

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.

Secondary Outcomes

  • Shoulder and Hand Questionnaire (Quick-DASH)(12th week)
  • Grip Strength:(12th week)
  • Measurement of Joint Range of Motion:(12th week)

Study Sites (1)

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