Lymphedema, Lower LimbNCT06454734
Shock Wave Therapy for Lower Limb Lymphedema
A study testing Extracorporeal shock wave therapy by radial device and DLT in people with Lymphedema, Lower Limb, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
This is a double-blind randomized clinical trial to compare the effect of shock wave therapy on lower limb lymphedema. There are two arms: A) complex decongestive therapy + extracorporeal shock waves therapy; B) complex decongestive therapy plus placebo extracorporeal shock waves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema, Lower Limb
- What is being tested?
- Extracorporeal shock wave therapy by radial device and DLT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 28 May 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lower limb lymphedema
- Lymphedema of at least 6 months of evolution
- The lymphedema must affect at least the knee to the foot
- Moderate or severe lymphedema (grades 2 or 3)
- Sign the informed consent
Who cannot join
- Under 18 years of age
- Coagulation disorders (hemophilia, treatment with acenocoumarol, etc.)
- Current or previous deep vein thrombosis of the lower extremity
- Pregnancy
- Electronic implantable medical devices as pacemaker implants, medication pumps, etc
- Having received treatment with complex decongestive therapy or shock waves during the last 6 months
Show all 11Show fewer
- Treatment with corticosteroids or radiotherapy in the area to be treated in the last 6 weeks
- Active oncological disease in the area to be treated
- Active infectious-inflammatory process in the area to be treated
- Cognitive or sensory deficits that prevent collaboration
- Inability to walk independently or inability to attend therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital del Mar
Barcelona, 08003
Esther Duarte, PhD, 933674214, eduarte@psmar.cat
Roser Belmonte, PhD, 933674214, rbelmonte@psmar.cat
About this study
Official title: Lower Limb Lymphedema Treatment by Extracorporeal Shock Wave Therapy: Clinical Trial
This is a double-blind randomized clinical trial to compare the effect of shock wave therapy on lower limb lymphedema. There are two arms: A) complex decongestive therapy + extracorporeal shock waves therapy; B) complex decongestive therapy plus placebo extracorporeal shock waves.
Read the detailed description
This is a double blind, randomized, clinical trial. 30 patients with lower limb lymphedema will be randomized in 2 groups. One group will receive the habitual complex decongestive therapy (lymphatic manual drainage and compression) plus extracorporeal shock waves therapy. The other group will receive complex decongestive therapy (lymphatic manual drainage and compression) plus placebo extracorporeal shock waves.
Patients in the 2 groups will be instructed on skin care measures and kinesitherapy. The usual manual lymphatic drainage and compression will be applied to the 2 groups. The 2 groups will receive 10 treatment sessions, 2 weekly for 5 weeks.
Group complex decongestive therapy + shock waves. Patients will receive treatment with manual lymphatic drainage, compression, and shock waves.
Group complex decongestant therapy + placebo. Patients will receive treatment with manual lymphatic drainage, compression, and placebo shock waves.
Tolerance and possible adverse effects will be recorded by physiotherapist. Any adverse effect detected will be evaluated by the rehabilitation medical doctor.
- Conditions
- Lymphedema, Lower Limb
- Being tested
- Extracorporeal shock wave therapy by radial device, Placebo extracorporeal shock wave therapy by radial device, DLT
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapy by radial deviceDevice
Also called Radial ESWT, rESWT
Patients will receive treatment by extracorporeal shock waves therapy (ESWT).
Placebo extracorporeal shock wave therapy by radial deviceDevice
Also called Radial ESWT, rESWT
Patients will receive treatment sham extracorporeal shock waves.
DLTOther
Also called Decongestive Lymphatic Therapy
Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)
| Study group | Role | What they receive |
|---|---|---|
| DLT + ESWT | Experimental | To DLT + ESWT group, decongestive lymphatic therapy (DLT) plus radial extracorporeal wave treatment (ESWT) will be applied, at a dose and intensity probed to be useful to diminish volume in upper limb lymphedema. Receives: Device: Extracorporeal shock wave therapy by radial device; Other: DLT |
| DLT + Sham ESWT | Sham comparator | To DLT + Sham ESWT group, decongestive lymphatic therapy plus sham radial extracorporeal wave treatment will be applied, at a placebo dose and intensity. Receives: Device: Placebo extracorporeal shock wave therapy by radial device; Other: DLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb volume change 1
The difference between limb volume previous of treatment and at the end of treatment
Measured: 5 weeks
Secondary outcomes (4)
Limb volume change 2
The difference between limb volume from previous of treatment to 1 month after
Measured: 9 weeks
VAS Pain
Changes in pain at previous treatment, at the end of treatment and to 1 month after. Measured by a visual analogue scale (VAS) (from 0 not pain to 10 maximum imaginable)
Measured: 9 weeks
VAS Heaviness
Changes in heaviness from previous treatment, to the end of treatment and to 1 month after. Measured by a visual analogue scale (VAS) (from 0 not heaviness to 10 maximum imaginable)
Measured: 9 weeks
VAS Hardness
Changes in hardness from previous treatment, to the end of treatment and to 1 month after. Measured by a visual analogue scale (VAS) (from 0 not hardness to 10 maximum imaginable)
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start28 May 2024
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lymphedema, Lower LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roser Belmonte, Parc de Salut Mar
- Investigators
- Roser Belmonte, MD, PhD, Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454734
- Sponsor's protocol ID
- 2023/11201/I
- Other IDs
- 2023
- Status last verified
- Jul 2025
- First submitted
- 28 May 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rankin J, Morris K, Reilly A. The All-Ireland Guidelines for the diagnosis, assessment and management of lymphoedema. Br J Community Nurs. 2022 Oct 1;27(Sup10):S22-S26. doi: 10.12968/bjcn.2022.27.Sup10.S22.
PubMed 36205409Bae 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.
PubMed 23705118Tsai 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.
PubMed 34945266Lee 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.
PubMed 32986941
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Limb Lymphedema Treatment by Extracorporeal Shock Wave Therapy: Clinical Trial
- ClinicalTrials.gov ID
- NCT06454734
- Acronym / sponsor ID
- 2023/11201/I
- Conditions
- Lymphedema, Lower Limb
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind randomized clinical trial to compare the effect of shock wave therapy on lower limb lymphedema. There are two arms: A) complex decongestive therapy + extracorporeal shock waves therapy; B) complex decongestive therapy plus placebo extracorporeal shock waves.
Detailed description
This is a double blind, randomized, clinical trial. 30 patients with lower limb lymphedema will be randomized in 2 groups. One group will receive the habitual complex decongestive therapy (lymphatic manual drainage and compression) plus extracorporeal shock waves therapy. The other group will receive complex decongestive therapy (lymphatic manual drainage and compression) plus placebo extracorporeal shock waves.
Patients in the 2 groups will be instructed on skin care measures and kinesitherapy. The usual manual lymphatic drainage and compression will be applied to the 2 groups. The 2 groups will receive 10 treatment sessions, 2 weekly for 5 weeks.
Group complex decongestive therapy + shock waves. Patients will receive treatment with manual lymphatic drainage, compression, and shock waves.
Group complex decongestant therapy + placebo. Patients will receive treatment with manual lymphatic drainage, compression, and placebo shock waves.
Tolerance and possible adverse effects will be recorded by physiotherapist. Any adverse effect detected will be evaluated by the rehabilitation medical doctor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| DLT + ESWT | Experimental | Device: Extracorporeal shock wave therapy by radial device, Other: DLTTo DLT + ESWT group, decongestive lymphatic therapy (DLT) plus radial extracorporeal wave treatment (ESWT) will be applied, at a dose and intensity probed to be useful to diminish volume in upper limb lymphedema. |
| DLT + Sham ESWT | Sham comparator | Device: Placebo extracorporeal shock wave therapy by radial device, Other: DLTTo DLT + Sham ESWT group, decongestive lymphatic therapy plus sham radial extracorporeal wave treatment will be applied, at a placebo dose and intensity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with lower limb lymphedema
- Lymphedema of at least 6 months of evolution
- The lymphedema must affect at least the knee to the foot
- Moderate or severe lymphedema (grades 2 or 3)
- Sign the informed consent
Key exclusion criteria (11 listed)
- Under 18 years of age
- Coagulation disorders (hemophilia, treatment with acenocoumarol, etc.)
- Current or previous deep vein thrombosis of the lower extremity
- Pregnancy
- Electronic implantable medical devices as pacemaker implants, medication pumps, etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shock wave therapy by radial deviceAlso: Radial ESWT, rESWTPatients will receive treatment by extracorporeal shock waves therapy (ESWT). | Device | DLT + ESWT |
| Placebo extracorporeal shock wave therapy by radial deviceAlso: Radial ESWT, rESWTPatients will receive treatment sham extracorporeal shock waves. | Device | DLT + Sham ESWT |
| DLTAlso: Decongestive Lymphatic TherapyPatients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression) | Other | DLT + ESWT, DLT + Sham ESWT |
Primary outcome
Limb volume change 1
Time frame: 5 weeks
The difference between limb volume previous of treatment and at the end of treatment
4 secondary outcomes
Limb volume change 2
Time frame: 9 weeks
VAS Pain
Time frame: 9 weeks
VAS Heaviness
Time frame: 9 weeks
VAS Hardness
Time frame: 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Background: PubMed 36205409Rankin J, Morris K, Reilly A. The All-Ireland Guidelines for the diagnosis, assessment and management of lymphoedema. Br J Community Nurs. 2022 Oct 1;27(Sup10):S22-S26. doi: 10.12968/bjcn.2022.27.Sup10.S22.
- Background: PubMed 23705118Bae 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.
- Background: PubMed 34945266Tsai 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.
- Background: PubMed 32986941Lee 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.
- Individual participant dataSharing planned: No
Related trials for Lymphedema, Lower Limb
Recruiting
The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema (the LymphEx Study)
Lymphedema
Recruiting
Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema
Lymphedema, Lower Limb, Extracorporeal Shock Wave Therapy
RecruitingEarly Phase 1
Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment
Lower Extremity Lymphedema
Not yet recruiting
Aerobic Exercise Effects in Lower Extremity Lymphedema
Lower Extremity Lymphedema
Recruiting
Boosted Compression for Lower Limb Chronic Edema
Chronic Edema, Lymphedema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roser Belmonte, MD, PhD principal investigator
Hospital del Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave therapy by radial device and DLT in people with Lymphedema, Lower Limb, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roser Belmonte, MD, PhD (+34 933674214, rbelmonte@psmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb volume change 1 (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06454734, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.