Effects of Extracorporeal Shock Wave Therapy (ESWT) and Low Intensity Laser Therapy (LLLT) Added to Complete Decongestive Therapy (CDT) on Extremity Volume, Pain Intensity, Functional Status and Quality of Life in Patients With Postmastectomy Stage 2 Lymphedema

Ankara City Hospital

Status: Completed

Conditions: Lymphedema, Breast Cancer

Treatments: Device: ESWT; Other: Complete Decongestive Therapy; Device: LLLT

Study type: Interventional

Funder types: Other

Identifiers

NCT06415396

10025145

Details and patient eligibility

About

This study aimed to comparatively investigate the effects of ESWT and LLLT added to conventional CDT (which is the standard treatment for breast cancer-related lymphedema) on patients' limb volume, pain intensity, functional status and quality of life.

Full description

after being informed study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility recruitments will get treatment into three groups in conventional complet decongestive therapy (CDT) program, electrocorporeal shock wave therapy (ESWT) combined with CDT program and low level laser therapy (LLLT) combined with CDT program

Enrollment: 66 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients with unilateral lymphedema after breast cancer-related surgery Patients whose chemotherapy and radiotherapy protocols have been completed Patients with stage 2 lymphedema according to ISL staging

Exclusion criteria

• Patients with arm edema before breast cancer

  • Patients with ongoing chemotherapy and radiotherapy Those with metastatic breast cancer Patients with acute infection Patients with BMI >35 Patients with pregnancy Patients who have previously received KDT Patients with active cancer Patients with recurrence or metastasis of breast cancer on follow-up imaging Those with decompensated heart failure Those with kidney failure Patients with liver failure Patients with a history of deep vein thrombosis in the last 3 months Those who are allergic to the dressing materials to be applied Patients with active infection or open wound on their extremities Those with cognitive impairment Patients with sensory deficits Immobilized patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

Complete Decongestive Therapy

Active Comparator group

Description:

22 breast cancer related lymphedema patients will received complete decongestive therapy

Treatment:

Other: Complete Decongestive Therapy

Complete Decongestive Therapy and ESWT

Active Comparator group

Description:

22 breast cancer related lymphedema patients will received ESWT added complete decongestive therapy

Treatment:

Other: Complete Decongestive Therapy

Device: ESWT

Complete Decongestive Therapy and LLLT

Active Comparator group

Description:

22 breast cancer related lymphedema patients will received LLLT added complete decongestive therapy

Treatment:

Other: Complete Decongestive Therapy

Device: LLLT