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

Lymphedema, Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05297643
• Other study ID #: 2
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: January 15, 2024

Study information

• Verified date: February 2023
• Source: Kirsehir Ahi Evran Universitesi
• Contact: Basak Cigdem Karacay, Asst Prof
• Phone: +905445094803
• Email: basak.cigdemkaracay[@]ahievran.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: January 15, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Be over 18 years old

2. History of lymphedema for at least 6 months after breast cancer treatment

3. Ending radiotherapy treatment at least 2 months ago

4. Not being included in the Complex DecongestiveTherapy program within 3 months

5. Having unilateral lymphedema

6. Having stage 2 lymphedema

7. Signing of the voluntary consent form

8. 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:

1. Active cancer

2. Skin infection, radiotherapy burn

3. Severely affected upper extremity range of motion 4 kidney failure

5. Heart failure 6. History of untreated deep venous thrombosis 7. Body mass index I=35 kg/m2 8. Using a pacemaker/internal defibrillator 9. Patients continuing radiotherapy and/or chemotherapy treatment 10. Having bilateral lymphedema 11. Pregnancy

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema
• Lymphedema, Breast Cancer

Intervention

Device:
• Ekstracorporeal Shock Wave Therapy (ESWT)
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

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

Locations

Country	Name	City	State
Turkey	Kirsehir Ahi Evran University Faculty of Medicine	Kirsehir	City Center

Sponsors (1)

Lead Sponsor	Collaborator
Kirsehir Ahi Evran Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Bae H, Kim HJ. Clinical outcomes of extracorporeal shock wave therapy in patients with secondary lymphedema: a pilot study. Ann Rehabil Med. 2013 Apr;37(2):229-34. doi: 10.5535/arm.2013.37.2.229. Epub 2013 Apr 30. — View Citation

Cebicci MA, Sutbeyaz ST, Goksu SS, Hocaoglu S, Oguz A, Atilabey A. Extracorporeal Shock Wave Therapy for Breast Cancer-Related Lymphedema: A Pilot Study. Arch Phys Med Rehabil. 2016 Sep;97(9):1520-1525. doi: 10.1016/j.apmr.2016.02.019. Epub 2016 Mar 15. — View Citation

Joos E, Vultureanu I, Nonneman T, Adriaenssens N, Hamdi M, Zeltzer A. Low-Energy Extracorporeal Shockwave Therapy as a Therapeutic Option for Patients with a Secondary Late-Stage Fibro-Lymphedema After Breast Cancer Therapy: A Pilot Study. Lymphat Res Bio — View Citation

Lee KW, Kim SB, Lee JH, Kim YS. Effects of Extracorporeal Shockwave Therapy on Improvements in Lymphedema, Quality of Life, and Fibrous Tissue in Breast Cancer-Related Lymphedema. Ann Rehabil Med. 2020 Oct;44(5):386-392. doi: 10.5535/arm.19213. Epub 2020 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Pain;	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.	Baseline
Primary	Evaluation of Pain;	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.	3th week (after treatment)
Primary	Evaluation of Pain;	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.	12th week
Primary	Environmental Measurement;	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.	Baseline
Primary	Environmental Measurement;	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.	3th week (after treatment)
Primary	Environmental Measurement;	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.	12th week
Secondary	Shoulder and Hand Questionnaire (Quick-DASH)	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.	Baseline
Secondary	Shoulder and Hand Questionnaire (Quick-DASH)	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.	3th week (after treatment)
Secondary	Shoulder and Hand Questionnaire (Quick-DASH)	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.	12th week
Secondary	Measurement of Joint Range of Motion:	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.	Baseline
Secondary	Measurement of Joint Range of Motion:	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.	3th week (after treatment)
Secondary	Measurement of Joint Range of Motion:	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.	12th week
Secondary	Grip Strength:	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.	Baseline
Secondary	Grip Strength:	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. .	3th week (after treatment)
Secondary	Grip Strength:	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.	12th week