Clinical trial NCT06454734: Shock Wave Therapy for Lower Limb Lymphedema
Official title: Lower Limb Lymphedema Treatment by Extracorporeal Shock Wave Therapy: Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphedema, Lower Limb
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized clinical trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion criteria

* 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

Exclusion criteria

* 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
* 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

Primary outcomes:
measure: Limb volume change 1
timeFrame: 5 weeks
Secondary outcomes:
measure: Limb volume change 2
timeFrame: 9 weeks
measure: VAS Pain
timeFrame: 9 weeks
measure: VAS Heaviness
timeFrame: 9 weeks
measure: VAS Hardness
timeFrame: 9 weeks
Other outcomes:
measure: Water composition
timeFrame: 9 weeks
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Hospital del Mar
name: Roser Belmonte, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.