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OpenTrials
Completed

NCT Number: NCT06415396

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara bilkent City Hospiatal Physical Therapy and Rehabilitation Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complete Decongestive Therapy

Other

conventional CDT program consisting of MLD, compression bandage, skin care and lymphedema exercises, for a total of 15 sessions, five days a week for three weeks.

ESWT

Device

ESWT was applied to the second group for a total of 5 sessions, 2 sessions in the first two weeks and 1 session in the last week. .

LLLT

Device

In the third group, LLLT was applied for a total of 9 sessions, 3 sessions per week, in addition to conventional CDT.

Primary outcomes

  1. Extremity volumes

    Time frame: Baseline, after three weeks

    Upper limb Volume measured by perometer

Secondary outcomes

  1. Lymphedema Quality of Life-arm (LYMQOL-arm )

    Time frame: Baseline, after three weeks

    quality of life questionnaire that is spesific for upper limb lymphedema

  2. Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire

    Time frame: Baseline, after three weeks

    questionnaire that shows functional status

  3. Visual Anologue Scale -Pain (VAS)

    Time frame: Baseline, after three weeks

    a straight line with one end meaning no pain and the other end meaning the worst pain imaginable

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 16, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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