Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema

NCT07626645 | Not Yet Recruiting

• 1 other identifier: GUFTR-LELymphedemaESWT-2026
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphedema, Lower Limb; Edema Leg; Sham-controlled; Placebo Control Design; Extracorporeal Shock Wave Therapy

Keywords

Lower Extremity Lymphedema; Extracorporeal Shock Wave Therapy (ESWT); Complex Decongestive Therapy (CDT); Limb Volume; Ultrasonography; skin and subcutaneous tissue thickness; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in Lower Extremity Limb Volume

  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.

  Baseline, immediately after treatment (week 3), and 1-month follow-up

Secondary Outcomes (5)

• Change in Lower Extremity Circumferential Measurements

  Baseline, immediately after treatment (week 3) and 1-month follow-up

• Change in Skin and Subcutaneous Tissue Thickness Assessed by Ultrasonography

  Baseline, immediately after treatment (week 3), and 1-month follow-up

• Change in Lymphedema-Specific Quality of Life (LYMQOL-Leg)

  Baseline, immediately after treatment (week 3), and 1-month follow-up

• Change in Lower Extremity Functional Status (LEFS)

  Baseline, immediately after treatment (week 3), and 1-month follow-up

• Change in Pain Intensity Measured by Visual Analogue Scale (VAS)

  Baseline, immediately after treatment (week 3), and 1-month follow-up

Study Arms (2)

ESWT + CDT Maintenance

EXPERIMENTAL

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.

Device: Extracorporeal Shock Wave Therapy (ESWT)

Sham ESWT + CDT Maintenance

SHAM COMPARATOR

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.

Device: Sham Extracorporeal Shock Wave Therapy (Sham ESWT)

Interventions

Extracorporeal Shock Wave Therapy (ESWT) DEVICE

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

Also known as: Extracorporeal Shock Wave Therapy, ESWT

ESWT + CDT Maintenance

Sham Extracorporeal Shock Wave Therapy (Sham ESWT) DEVICE

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.

Also known as: Sham Extracorporeal Shock Wave Therapy, Sham ESWT

Sham ESWT + CDT Maintenance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Hospital, Department of Physical Medicine and Rehabilitation, Ankara, 06560

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

Location

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 BACKGROUND

• 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.

  PMID: 40588402 BACKGROUND

• 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.

  PMID: 34945266 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Lymphedema

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Ayca Utkan Karasu, M.D

CONTACT

+905365759757; ayca_utkan@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to group allocation as sham ESWT is applied using identical positioning and device application as active ESWT, with only non-energized impulses delivered. Outcome assessments will be performed by an assessor who is blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Model Details: Participants with lower extremity lymphedema will be randomly assigned to two parallel groups. The intervention group will receive active Extracorporeal Shock Wave Therapy (ESWT) in addition to standard Complex Decongestive Therapy (CDT) maintenance, while the control group will receive sham ESWT in addition to standard CDT maintenance. Both groups will continue compression garment use, skin care, and exercise throughout the study. ESWT will be administered twice weekly for five sessions.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

TU (1)