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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal shock wave therapy by radial device | Device | Patients will receive treatment by extracorporeal shock waves therapy (ESWT). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Limb volume change 1 | The difference between limb volume previous of treatment and at the end of treatment | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Limb volume change 2 | The difference between limb volume from previous of treatment to 1 month after | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Water composition | Changes in water lower limb composition at previous treatment, to the end of treatment anto 1 month after. | 9 weeks |
Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roser Belmonte, MD, PhD | Contact | +34 933674214 | rbelmonte@psmar.cat | |
| Esther Duarte, MD, PhD | Contact | +34 933674214 | eduarte@psmar.cat |
| Name | Affiliation | Role |
|---|---|---|
| Roser Belmonte, MD, PhD | Hospital del Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Recruiting | Barcelona | 08003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36205409 | Background | 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. | |
| 23705118 | Background | 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. |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Double blind randomized clinical trial
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Patients, outcome assessors and investigators will not know if received treatment was placebo or therapeutic. The physiotherapist will apply the treatment according to a list of random numbers generated to make 2 treatment groups
| Placebo extracorporeal shock wave therapy by radial device | Device | Patients will receive treatment sham extracorporeal shock waves. |
|
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| DLT | Other | Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression) |
|
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| 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) | 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) | 9 weeks |
| 34945266 | 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. |
| 32986941 | 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. |