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

NCT05297643 | Unknown

• 1 other identifier: 2
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema, Breast Cancer

Keywords

Lymphedema; Complex DecongestiveTherapy; Extracorporeal Shock Wave Therapy

Outcome Measures

Primary Outcomes (6)

• 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

• 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)

• 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

• 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

• 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)

• 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 Outcomes (9)

• Shoulder and Hand Questionnaire (Quick-DASH)

  Baseline

• Shoulder and Hand Questionnaire (Quick-DASH)

  3th week (after treatment)

• Shoulder and Hand Questionnaire (Quick-DASH)

  12th week

• Measurement of Joint Range of Motion:

  Baseline

• Measurement of Joint Range of Motion:

  3th week (after treatment)

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Device: Ekstracorporeal Shock Wave Therapy (ESWT); Other: complex decongestive therapy

control group

OTHER

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

Other: complex decongestive therapy

Interventions

Ekstracorporeal Shock Wave Therapy (ESWT) DEVICE

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

Experimental Group

complex decongestive therapy OTHER

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

Experimental Group; control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: BREAST CANCER-RELATED LYMPHEDEMA ONLY OCCUR IN WOMEN
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active cancer
• Skin infection, radiotherapy burn
• Severely affected upper extremity range of motion 4 kidney failure
• \. 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kırşehir Ahi Evran University Faculty of Medicine

Kırşehir, City Center, 40100, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 26987620 RESULT

• 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.

  PMID: 32986941 RESULT

• 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.

  PMID: 32780632 RESULT

• 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.

  PMID: 23705118 RESULT

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Basak Cigdem Karacay, Asst Prof

  Kirsehir Ahi Evran Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basak Cigdem Karacay, Asst Prof

CONTACT

+905445094803; basak.cigdemkaracay@ahievran.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: randomized controlled trials

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 15, 2024
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

TU (1)