Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2024-05-28
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Extracorporeal Shockwave Therapy Based on Fascial Manipulation Theory for Lateral Epicondylitis
NCT07131423
ESWT for Primary Lipedema
NCT07240415
Physical Therapies in the Decongestive Treatment of Lymphedema
NCT01748604
Effects of Extracorporeal Shock Wave Therapy and Pulse Electromagnetic Field Therapy on Lymphoedema
NCT06041958
Comparison of Two Different Treatment Effects on Individuals With Chronic Lateral Epicondylitis
NCT04187287
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DLT + ESWT
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.
Extracorporeal shock wave therapy by radial device
Patients will receive treatment by extracorporeal shock waves therapy (ESWT).
DLT
Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)
DLT + Sham ESWT
To DLT + Sham ESWT group, decongestive lymphatic therapy plus sham radial extracorporeal wave treatment will be applied, at a placebo dose and intensity.
Placebo extracorporeal shock wave therapy by radial device
Patients will receive treatment sham extracorporeal shock waves.
DLT
Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Extracorporeal shock wave therapy by radial device
Patients will receive treatment by extracorporeal shock waves therapy (ESWT).
Placebo extracorporeal shock wave therapy by radial device
Patients will receive treatment sham extracorporeal shock waves.
DLT
Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Parc de Salut Mar
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Roser Belmonte
Rehabilitation specialist, MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Roser Belmonte, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital del Mar
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital del Mar
Barcelona, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023/11201/I
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.