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

NCT06415396 | Completed

• 1 other identifier: 10025145
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema, Breast Cancer

Keywords

Lymphedema; ESWT; LLLT

Outcome Measures

Primary Outcomes (1)

• Extremity volumes

  Upper limb Volume measured by perometer

  Baseline, after three weeks

Secondary Outcomes (3)

• Lymphedema Quality of Life-arm (LYMQOL-arm )

  Baseline, after three weeks

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

  Baseline, after three weeks

• Visual Anologue Scale -Pain (VAS)

  Baseline, after three weeks

Study Arms (3)

Complete Decongestive Therapy

ACTIVE COMPARATOR

22 breast cancer related lymphedema patients will received complete decongestive therapy

Other: Complete Decongestive Therapy

Complete Decongestive Therapy and ESWT

ACTIVE COMPARATOR

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

Other: Complete Decongestive Therapy; Device: ESWT

Complete Decongestive Therapy and LLLT

ACTIVE COMPARATOR

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

Other: Complete Decongestive Therapy; Device: LLLT

Interventions

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.

Complete Decongestive Therapy; Complete Decongestive Therapy and ESWT; Complete Decongestive Therapy and LLLT

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. .

Complete Decongestive Therapy and ESWT

LLLT DEVICE

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

Complete Decongestive Therapy and LLLT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: we received female patients who had postmastectomy lymphedema
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara bilkent City Hospiatal Physical Therapy and Rehabilitation Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (2)

• Lee JH, Kim SB, Lee KW, Ha WW. Long-Term Effects of Extracorporeal Shock Wave Therapy on Breast Cancer-Related Lymphedema. J Clin Med. 2022 Nov 15;11(22):6747. doi: 10.3390/jcm11226747.

  PMID: 36431224 BACKGROUND

• Baxter GD, Liu L, Petrich S, Gisselman AS, Chapple C, Anders JJ, Tumilty S. Low level laser therapy (Photobiomodulation therapy) for breast cancer-related lymphedema: a systematic review. BMC Cancer. 2017 Dec 7;17(1):833. doi: 10.1186/s12885-017-3852-x.

  PMID: 29216916 BACKGROUND

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• BilgeBüşra Ceylan, Medical Doctor

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: December 1, 2021
• Primary Completion: June 20, 2023
• Study Completion: June 25, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)