EFFECT OF ESWT ON BREAST-CANCER RELATED LYMPHEDEMA
ConditionBreast Cancer Related Lymphedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAnkara City Hospital Bilkent
About this trial
The aim of this study is to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) combined with complete decongestive therapy (CDT) compared with CDT alone in patients with breast cancer-related lymphedema.
Female patients with unilateral Stage II upper-extremity lymphedema related to breast cancer will be included. Participants will receive either complete decongestive therapy alone or complete decongestive therapy combined with extracorporeal shock wave therapy.
Clinical outcomes will be evaluated before treatment, immediately after treatment, and at 1 and 3 months after treatment. Primary outcomes will include limb circumference difference, volumetric measurements, and ultrasonographic assessment of skin and subcutaneous tissue thickness. Secondary outcomes will include upper-extremity function, quality of life, and pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Complete Decongestive Therapy
Other interventionComplete decongestive therapy will consist of manual lymphatic drainage performed by an experienced physiotherapist according to the Vodder technique for 45-60 minutes, followed by multilayer short-stretch bandaging and lymphedema exercises performed under the supervision of the physiotherapist. Treatment will be administered five sessions per week for a total of 15 sessions. Arm Cross-Reference: Complete Decongestive Therapy Complete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy
Extracorporeal Shock Wave Therapy
DeviceRadial extracorporeal shock wave therapy will be administered using a pressure of 2 bar, a frequency of 4 Hz, and a total of 2,500 shocks per session. The shocks will be distributed as follows: Axillary region: 750 shocks Upper arm: 500 shocks Cubital region: 250 shocks Forearm: 500 shocks Dorsum of the hand: 500 shocks ESWT will be administered three sessions per week for three weeks. Arm Cross-Reference: Complete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Complete Decongestive TherapyActive comparator 1 intervention
Group B: Complete Decongestive Therapy Plus Extracorporeal Shock Wave TherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Upper-Extremity Circumference Difference
Circumference measurements will be obtained from both the affected and unaffected upper extremities, and the difference between the two extremities will be recorded.
Time frame
Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.2
Change in Upper-Extremity Volume
Upper-extremity volume will be calculated from serial circumference measurements using the truncated cone formula.
Time frame
Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.3
Change in Skin and Subcutaneous Tissue Thickness Assessed by Ultrasonography
Skin and subcutaneous tissue thickness will be assessed ultrasonographically at the dorsum of the hand, forearm, and upper arm.
Time frame
Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.Secondary outcomes
1
Change in Upper-Extremity Function Assessed by the QuickDASH
Upper-extremity functional status will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
Time frame
Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.2
Change in Lymphedema-Related Quality of Life Assessed by LYMQOL
Lymphedema-related quality of life will be assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL).
Time frame
Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.3
Change in Upper-Extremity Pain Assessed by Visual Analog Scale
Upper-extremity pain experienced during the previous week will be evaluated using a Visual Analog Scale (VAS).
Time frame
Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.Sponsors and contacts
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Source ClinicalTrials.gov