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

Not Applicable

Completed

• Conditions: Lymphedema, Breast Cancer

• Registration Number: NCT06415396
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2023-06-20
• Study Completion: 2023-06-25
• Status Verified: 2024-05
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-14
• Last Update Submitted: 2024-05-14
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Extremity volumes	Baseline, after three weeks	Upper limb Volume measured by perometer

Secondary Outcome Measures

Name	Time	Method
Lymphedema Quality of Life-arm (LYMQOL-arm )	Baseline, after three weeks	quality of life questionnaire that is spesific for upper limb lymphedema
Visual Anologue Scale -Pain (VAS)	Baseline, after three weeks	a straight line with one end meaning no pain and the other end meaning the worst pain imaginable
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire	Baseline, after three weeks	questionnaire that shows functional status

Trial Locations

Locations (1)

Ankara bilkent City Hospiatal Physical Therapy and Rehabilitation Hospital; 🇹🇷 Ankara, Çankaya, Turkey