Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema
2026年9月11日 更新者：Ayça Utkan Karasu、Gazi University
Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Lower Extremity Lymphedema: A Randomized Controlled Trial
Lower extremity lymphedema is a chronic and progressive condition associated with significant functional impairment and reduced quality of life.
The current gold-standard treatment is Complex Decongestive Therapy (CDT); however, a substantial proportion of patients continue to experience persistent symptoms during the maintenance phase.
This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) as an adjunct to standard CDT maintenance therapy in patients with lower extremity lymphedema.
Participants will be randomly allocated to either an active ESWT group or a sham ESWT group, with both groups continuing standard CDT maintenance throughout the study.
ESWT will be administered twice weekly for five sessions.
Changes in limb volume, skin thickness and subcutaneous tissue thickness assessed by ultrasonography, pain, functional status, and quality of life will be evaluated at baseline, after treatment, and at one-month follow-up.
調査の概要
状態
募集
詳細な説明
Lower extremity lymphedema results from impairment of the lymphatic system and is characterized by progressive tissue fibrosis, chronic limb swelling, recurrent infections, and reduced quality of life. Complex Decongestive Therapy (CDT), recommended by the International Society of Lymphology, remains the gold-standard treatment. Despite adherence to CDT, many patients continue to experience persistent symptoms and functional decline, underscoring the need for effective adjunctive interventions.
Extracorporeal Shock Wave Therapy (ESWT) is a non-invasive modality that has shown potential benefits in reducing fibrosis and improving lymphatic function. While its efficacy has been reported in upper extremity lymphedema, evidence in lower extremity lymphedema remains limited.
This single-center, prospective, randomized, double-blind, placebo-controlled trial will be conducted at the Department of Physical Medicine and Rehabilitation, Gazi University Faculty of Medicine. Patients currently in CDT Phase 2 (maintenance phase) will be randomly assigned in a 1:1 ratio to receive either active ESWT or sham ESWT, using stratified randomization by lymphedema stage. All participants will continue standard maintenance therapy - compression garments, skin care, and exercise - throughout the study. ESWT will be applied to fibrotic tissue regions and periinguinal and peripopliteal lymph node areas using the EMS Swiss DolorClast® device, with 3,000 impulses per session at 20 Hz and 2 bar. The primary outcome is change in lower extremity circumferential measurements and limb volume. Secondary outcomes include skin and subcutaneous tissue thickness assessed by ultrasonography, pain intensity measured by the Visual Analogue Scale (VAS), lymphedema-specific quality of life evaluated by the LYMQOL-Leg, and functional status assessed by the Lower Extremity Functional Scale (LEFS). All outcomes will be assessed at baseline, immediately after treatment, and at one-month follow-up.
研究の種類
介入
入学 (推定)
36
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ayca Utkan Karasu, M.D
- 電話番号：+903122025219 +905365759757
- メール：ayca_utkan@yahoo.com
研究場所
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Yenimahalle
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Ankara、Yenimahalle、トルコ（Türkiye）、06560
- 募集
- Gazi University Hospital, Department of Physical Medicine and Rehabilitation, Ankara, 06560
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主任研究者：
- Ayca Utkan Karasu, MD
-
コンタクト：
- Ayca Utkan Karasu, MD
- 電話番号：+903122025219 +905365759757
- メール：ayca_utkan@yahoo.com
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コンタクト：
- Turkan Gokcelik, MD
- 電話番号：+905078492343
- メール：turkancanturk@gmail.com
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主任研究者：
- Turkan Gokcelik, MD
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副調査官：
- Ilknur Onurlu, MD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Adults aged 18 to 80 years
- Clinical diagnosis of lower extremity lymphedema established at least 6 months prior to enrollment
- Completion of at least one cycle of CDT Phase 1 (intensive decongestive phase) within the preceding six months
- Currently in CDT Phase 2 (maintenance phase) with active use of compression garments
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Active chemotherapy or radiotherapy
- Active infection
- Lower extremity vascular diseases including deep vein thrombosis or arterial insufficiency
- Presence of a cardiac pacemaker
- Pregnancy
- Bleeding disorders
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：ESWT + CDT Maintenance
Participants in this group receive active Extracorporeal Shock Wave Therapy (ESWT) applied to fibrotic tissue regions of the affected lower extremity and periinguinal and peripopliteal lymph node areas, in addition to standard CDT maintenance therapy.
ESWT will be administered twice weekly for a total of five sessions.
|
Radial shock wave therapy will be applied using the EMS Swiss DolorClast® device.
Each session will consist of 3,000 impulses delivered at 20 Hz and 2 bar using a 40 mm applicator, targeting fibrotic tissue regions and periinguinal and peripopliteal lymph node areas.
ESWT will be administered twice weekly for five sessions
他の名前：
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偽コンパレータ：Sham ESWT + CDT Maintenance
Participants in this group receive sham ESWT applied to the same anatomical regions using identical device positioning and application procedures, but with only non-energized impulses delivered.
Standard CDT maintenance therapy will be continued throughout the study.
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Sham ESWT will be applied with identical positioning and session duration as the active ESWT group.
Only non-energized impulses will be delivered, ensuring participant blinding.
Sham ESWT will be administered twice weekly for five sessions.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Lower Extremity Limb Volume
時間枠：Baseline, immediately after treatment (week 3), and 1-month follow-up
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Change in lower extremity limb volume calculated using the truncated cone formula.
Volume will be estimated from circumferential measurements taken at 4 cm intervals from approximately 2 cm proximal to the medial malleolus to the inguinal region, with the patient in the supine position.
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Baseline, immediately after treatment (week 3), and 1-month follow-up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Lower Extremity Circumferential Measurements
時間枠：Baseline, immediately after treatment (week 3) and 1-month follow-up
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Change in lower extremity circumferential measurements taken at 4 cm intervals from approximately 2 cm proximal to the medial malleolus to the inguinal region, with the patient in the supine position using a non-elastic tape measure.
The difference between baseline and post-treatment values will be compared between groups.
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Baseline, immediately after treatment (week 3) and 1-month follow-up
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Change in Skin and Subcutaneous Tissue Thickness Assessed by Ultrasonography
時間枠：Baseline, immediately after treatment (week 3), and 1-month follow-up
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Change in skin and subcutaneous tissue thickness measured by B-mode linear ultrasonography at standardized anatomical sites on the affected lower extremity.
Three measurements will be obtained at each site and averaged.
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Baseline, immediately after treatment (week 3), and 1-month follow-up
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Change in Lymphedema-Specific Quality of Life (LYMQOL-Leg)
時間枠：Baseline, immediately after treatment (week 3), and 1-month follow-up
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Lymphedema-specific quality of life will be assessed using the LYMQOL-Leg questionnaire, a patient-reported outcome measure consisting of 22 items evaluating function, body image, symptoms, and emotional well-being.
Each item is scored from 1 to 4, and an overall quality of life score is rated separately on a scale from 0 to 10, with higher scores indicating better quality of life.
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Baseline, immediately after treatment (week 3), and 1-month follow-up
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Change in Lower Extremity Functional Status (LEFS)
時間枠：Baseline, immediately after treatment (week 3), and 1-month follow-up
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Lower extremity functional status will be assessed using the Lower Extremity Functional Scale (LEFS).
The LEFS consists of 20 items, each scored from 0 to 4, yielding a total score ranging from 0 (extreme difficulty or inability to perform all activities) to 80 (no difficulty), with higher scores indicating better functional status.
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Baseline, immediately after treatment (week 3), and 1-month follow-up
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Change in Pain Intensity Measured by Visual Analogue Scale (VAS)
時間枠：Baseline, immediately after treatment (week 3), and 1-month follow-up
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Pain intensity will be assessed using a 10 cm Visual Analogue Scale (VAS).
Scores range from 0 (no pain) to 10 (worst imaginable pain), with lower scores indicating less pain.
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Baseline, immediately after treatment (week 3), and 1-month follow-up
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Tsai YL, I TJ, Chuang YC, Cheng YY, Lee YC. Extracorporeal Shock Wave Therapy Combined with Complex Decongestive Therapy in Patients with Breast Cancer-Related Lymphedema: A Systemic Review and Meta-Analysis. J Clin Med. 2021 Dec 19;10(24):5970. doi: 10.3390/jcm10245970.
- 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.
- 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.
- Zhou JP, Lin YY, Zhu MF, Situ XX, Wang J. [Clinical effects of extracorporeal shock wave combined with complex decongestive therapy in the treatment of lower limb lymphedema after cervical cancer surgery]. Zhonghua Shao Shang Yu Chuang Mian Xiu Fu Za Zhi. 2025 Jun 20;41(6):543-551. doi: 10.3760/cma.j.cn501225-20250205-00051. Chinese.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年9月1日
一次修了 (推定)
2027年2月1日
研究の完了 (推定)
2027年2月1日
試験登録日
最初に提出
2026年5月21日
QC基準を満たした最初の提出物
2026年6月2日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月15日
QC基準を満たした最後の更新が送信されました
2026年9月11日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- GUFTR-LELymphedemaESWT-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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