Evaluation of the Effectiveness of Complex Decongestive Therapy and Extracorporeal Shock Wave Therapy in Patients With Lymphedema
Sponsor study identifier
interventional
21
1 country
1
Study Start
October 5, 2022
Actual (reported)Primary Completion
April 1, 2024
Actual (reported)Study Completion
April 1, 2024
Actual (reported)Arm swelling can persist after breast cancer treatment and may interfere with comfort, movement, and everyday activities. Decongestive care combines several approaches to manage this swelling. This study examined whether adding radial shock wave treatment changed short-term outcomes compared with decongestive care alone. Twenty-one adults with stage 2 or stage 3 lymphedema affecting one arm were assigned to two treatment groups. Both groups were allocated to a four-week decongestive program. The combined-treatment schedule also included twelve shock wave sessions. Assessments before and after treatment covered arm size, the thickness of the skin and the tissue beneath it, pain, difficulty using the arm, lymphedema-related quality of life, and shoulder and wrist movement. A physician who did not know the treatment assignment performed the physical and ultrasound measurements.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2024
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 5, 2022
Actual (reported)April 1, 2024
Actual (reported)April 1, 2024
Actual (reported)October 1, 2026
Actual (reported)October 7, 2026
Actual (reported)Reduction in calculated affected upper-limb volume
Volume of the affected upper limb was estimated from circumference measurements using the truncated-cone method and expressed in liters. The week-4 volume was subtracted from the pretreatment volume. A positive value indicates a reduction in calculated limb volume.
Before the first treatment session and at the end of the four-week treatment course.
Reduction in arm circumference 10 cm above the cubital fossa
Before the first treatment session and at the end of the four-week treatment course.
Reduction in forearm circumference 10 cm below the cubital fossa
Before the first treatment session and at the end of the four-week treatment course.
Reduction in skin thickness at 10 cm proximal to the cubital fossa
Before the first treatment session and at the end of the four-week treatment course.
Reduction in skin thickness at the cubital fossa
Before the first treatment session and at the end of the four-week treatment course.
Reduction in skin thickness at 10 cm distal to the cubital fossa
Before the first treatment session and at the end of the four-week treatment course.
Participants were allocated to a four-week course of complex decongestive therapy with additional radial extracorporeal shock wave treatment. Decongestive sessions were scheduled on five days each week, and shock wave sessions on three days each week.
Participants were allocated to the same four-week complex decongestive program, without shock wave treatment. The planned schedule consisted of five treatment days per week.
The planned course comprised four weeks of treatment on five days per week. Components included manual lymphatic drainage, multilayer short-stretch bandaging, skin care, and therapeutic exercise. Exercise activities addressed breathing, posture, shoulder-girdle movement, gentle stretching, and low-intensity active movement of the upper limb and fingers. Movements were performed slowly within a pain-free range while the compression bandages were in place.
Selcuk University Faculty of Medicine Hospital
Konya, Konya, 42250, Turkey (Türkiye)
21 participants (actual enrollment reported by the registry).
First Submitted
October 1, 2026
First Posted
October 7, 2026
Study Start
October 5, 2022
Actual (reported)An Intelect RPW Lite system (Chattanooga) was used to deliver radial pressure pulses with the participant lying supine. The scheduled regimen consisted of three sessions per week for four weeks. Each session used a pressure setting of 2 bar and a frequency of 4 Hz, with 2,500 pulses in total. Of these, 750 were directed to the axillary region and 250 to the cubital region; the remaining 1,500 were distributed across the arm, forearm, and hand.
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Primary Completion
April 1, 2024
Actual (reported)Study Completion
April 1, 2024
Actual (reported)Last Updated
October 7, 2026
Record last verified: 2026-10
De-identified participant-level data supporting the published findings will be made available to researchers following approval of a reasonable request submitted to the corresponding author. Requests will be assessed by the study team. Any data transfer will be subject to applicable institutional and ethical requirements and must be consistent with participant consent and the protection of participant confidentiality.
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Source: ClinicalTrials.gov.
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