Lymphedema, Lower Limb, Extracorporeal Shock Wave Therapy, Edema Leg, Sham-controlled, Placebo Control Design
Conditions
Keywords
Lower Extremity Lymphedema, Extracorporeal Shock Wave Therapy (ESWT), Complex Decongestive Therapy (CDT), Limb Volume, Ultrasonography, skin and subcutaneous tissue thickness, Quality of Life
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.
Detailed description
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.
Interventions
DEVICEExtracorporeal Shock Wave Therapy (ESWT)
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
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.
Sponsors
Gazi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lower Extremity Limb Volume | Baseline, immediately after treatment (week 3), and 1-month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lower Extremity Circumferential Measurements | Baseline, immediately after treatment (week 3) and 1-month follow-up | 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. |
| Change in Skin and Subcutaneous Tissue Thickness Assessed by Ultrasonography | Baseline, immediately after treatment (week 3), and 1-month follow-up | 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. |
| Change in Lymphedema-Specific Quality of Life (LYMQOL-Leg) | Baseline, immediately after treatment (week 3), and 1-month follow-up | 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. |
| Change in Lower Extremity Functional Status (LEFS) | Baseline, immediately after treatment (week 3), and 1-month follow-up | 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. |
| Change in Pain Intensity Measured by Visual Analogue Scale (VAS) | Baseline, immediately after treatment (week 3), and 1-month follow-up | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAyca Utkan Karasu, M.D
Outcome results
None listed