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

Lymphedema, Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06415396
• Other study ID #: 10025145
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: June 25, 2023

Study information

• Verified date: May 2024
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 25, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Lymphedema
• Lymphedema, Breast Cancer
• Pain

Intervention

Other:
• Complete Decongestive Therapy
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.

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

Locations

Country	Name	City	State
Turkey	Ankara bilkent City Hospiatal Physical Therapy and Rehabilitation Hospital	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extremity volumes	Upper limb Volume measured by perometer	Baseline, after three weeks
Secondary	Lymphedema Quality of Life-arm (LYMQOL-arm )	quality of life questionnaire that is spesific for upper limb lymphedema	Baseline, after three weeks
Secondary	Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire	questionnaire that shows functional status	Baseline, after three weeks
Secondary	Visual Anologue Scale -Pain (VAS)	a straight line with one end meaning no pain and the other end meaning the worst pain imaginable	Baseline, after three weeks