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

Primary Purpose

Lymphedema, Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ekstracorporeal Shock Wave Therapy (ESWT)
complex decongestive therapy
Sponsored by
Kirsehir Ahi Evran Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema, Breast Cancer focused on measuring Lymphedema, Complex DecongestiveTherapy, Extracorporeal Shock Wave Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kırşehir Ahi Evran University Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental Group

control group

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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. .
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.

Full Information

First Posted
March 17, 2022
Last Updated
February 8, 2023
Sponsor
Kirsehir Ahi Evran Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05297643
Brief Title
Effects of Extracorporeal Shock Wave Therapy Added To Complex DecongestiveTherapy In Patıent With Lymphedeme
Official Title
Effects of Extracorporeal Shock Wave Therapyy Added To Complex DecongestiveTherapy In Patient With Breast Cancer Releated Lymphedema
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Breast Cancer
Keywords
Lymphedema, Complex DecongestiveTherapy, Extracorporeal Shock Wave Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trials
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Ekstracorporeal Shock Wave Therapy (ESWT)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
complex decongestive therapy
Intervention Description
Complex decongestive therapy consists of manual lymphatic degeneration, compression therapy, skin care and remedal exercise.
Primary Outcome Measure Information:
Title
Evaluation of Pain;
Description
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.
Time Frame
Baseline
Title
Evaluation of Pain;
Description
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.
Time Frame
3th week (after treatment)
Title
Evaluation of Pain;
Description
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.
Time Frame
12th week
Title
Environmental Measurement;
Description
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.
Time Frame
Baseline
Title
Environmental Measurement;
Description
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.
Time Frame
3th week (after treatment)
Title
Environmental Measurement;
Description
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.
Time Frame
12th week
Secondary Outcome Measure Information:
Title
Shoulder and Hand Questionnaire (Quick-DASH)
Description
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.
Time Frame
Baseline
Title
Shoulder and Hand Questionnaire (Quick-DASH)
Description
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.
Time Frame
3th week (after treatment)
Title
Shoulder and Hand Questionnaire (Quick-DASH)
Description
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.
Time Frame
12th week
Title
Measurement of Joint Range of Motion:
Description
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.
Time Frame
Baseline
Title
Measurement of Joint Range of Motion:
Description
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.
Time Frame
3th week (after treatment)
Title
Measurement of Joint Range of Motion:
Description
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.
Time Frame
12th week
Title
Grip Strength:
Description
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.
Time Frame
Baseline
Title
Grip Strength:
Description
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. .
Time Frame
3th week (after treatment)
Title
Grip Strength:
Description
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.
Time Frame
12th week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
BREAST CANCER-RELATED LYMPHEDEMA ONLY OCCUR IN WOMEN
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Basak Cigdem Karacay, Asst Prof
Phone
+905445094803
Email
basak.cigdemkaracay@ahievran.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Basak Cigdem Karacay, Asst Prof
Organizational Affiliation
Kirsehir Ahi Evran Universitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kırşehir Ahi Evran University Faculty of Medicine
City
Kırşehir
State/Province
City Center
ZIP/Postal Code
40100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Basak Cigdem Karacay
Phone
0905445094803
Email
basak.cigdemkaracay@ahievran.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26987620
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.
Results Reference
result
PubMed Identifier
32986941
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 Sep 28.
Results Reference
result
PubMed Identifier
32780632
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 Biol. 2021 Apr;19(2):175-180. doi: 10.1089/lrb.2020.0033. Epub 2020 Aug 11.
Results Reference
result
PubMed Identifier
23705118
Citation
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.
Results Reference
result

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

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