Breast Cancer Lymphedema
Conditions
Keywords
Upper-limb lymphedema, Radial extracorporeal shock wave therapy, Complex decongestive therapy, Ultrasonography, Cancer rehabilitation, Arm function
Brief summary
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.
Detailed description
This single-center study evaluated a noninvasive addition to intensive rehabilitation for unilateral upper-limb lymphedema following breast cancer treatment. It was conducted at the Physical Medicine and Rehabilitation Clinic of Selcuk University Faculty of Medicine Hospital in Konya, Türkiye. The comparison was designed to examine the contribution of radial shock wave treatment separately from the decongestive program received by both groups. Overall limb measurements and regional ultrasound assessments were used to examine different aspects of the response to treatment. Questionnaires and joint measurements provided complementary information about symptoms, everyday arm use, and mobility. The assessment schedule included examinations before treatment and at the end of the four-week course. Circumference measurements were also obtained weekly during the intervention period. The same physician performed the objective assessments without knowledge of group assignment. Participants and the personnel providing treatment were aware of the assigned intervention. The Selcuk University Faculty of Medicine Local Ethics Committee approved the study on October 4, 2022, under decision number 2022/410. Each participant provided written consent. This record describes a study that had already been completed before its initial submission to ClinicalTrials.gov.
Interventions
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.
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.
Sponsors
Selcuk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older. * A history of breast cancer with unilateral upper-limb lymphedema established by clinical evaluation and lymphoscintigraphy. * Stage 2 or stage 3 lymphedema according to the International Society of Lymphology classification. * Availability of electronic medical records containing sex, age, weight, height, body mass index, occupation, comorbid conditions, medication use, and chemotherapy and radiotherapy history. * Written informed consent to participate.
Exclusion criteria
* Active malignancy. * Ongoing chemotherapy or radiotherapy. * Clinical evidence of infection in the affected upper limb. * Advanced cardiac or renal failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in calculated affected upper-limb volume | Before the first treatment session and at the end of the four-week treatment course. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Circumference of the affected arm was measured in centimeters at a level 10 cm proximal to the cubital fossa. The reduction was calculated as the pretreatment measurement minus the week-4 measurement. Positive values represent a smaller circumference after treatment. |
| 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. | Circumference of the affected forearm was recorded in centimeters at a level 10 cm distal to the cubital fossa. The week-4 measurement was subtracted from the pretreatment measurement. Positive values represent a decrease in circumference. |
| 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. | The thickness of the skin in the affected upper limb was measured 10 cm proximal to the cubital fossa by ultrasound using a linear-array transducer. Values were recorded in millimeters by the masked physician. Reduction was calculated as pretreatment thickness minus week-4 thickness; a positive value denotes thinning of the measured layer. |
| Reduction in skin thickness at the cubital fossa | Before the first treatment session and at the end of the four-week treatment course. | The thickness of the skin in the affected upper limb was measured at the cubital fossa by ultrasound using a linear-array transducer. Values were recorded in millimeters by the masked physician. Reduction was calculated as pretreatment thickness minus week-4 thickness; a positive value denotes thinning of the measured layer. |
| 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. | The thickness of the skin in the affected upper limb was measured 10 cm distal to the cubital fossa by ultrasound using a linear-array transducer. Values were recorded in millimeters by the masked physician. Reduction was calculated as pretreatment thickness minus week-4 thickness; a positive value denotes thinning of the measured layer. |
| Reduction in subcutaneous tissue thickness at 10 cm proximal to the cubital fossa | Before the first treatment session and at the end of the four-week treatment course. | The thickness of the subcutaneous tissue in the affected upper limb was measured 10 cm proximal to the cubital fossa by ultrasound using a linear-array transducer. Values were recorded in millimeters by the masked physician. Reduction was calculated as pretreatment thickness minus week-4 thickness; a positive value denotes thinning of the measured layer. |
| Reduction in subcutaneous tissue thickness at the cubital fossa | Before the first treatment session and at the end of the four-week treatment course. | The thickness of the subcutaneous tissue in the affected upper limb was measured at the cubital fossa by ultrasound using a linear-array transducer. Values were recorded in millimeters by the masked physician. Reduction was calculated as pretreatment thickness minus week-4 thickness; a positive value denotes thinning of the measured layer. |
| Reduction in subcutaneous tissue thickness at 10 cm distal to the cubital fossa | Before the first treatment session and at the end of the four-week treatment course. | The thickness of the subcutaneous tissue in the affected upper limb was measured 10 cm distal to the cubital fossa by ultrasound using a linear-array transducer. Values were recorded in millimeters by the masked physician. Reduction was calculated as pretreatment thickness minus week-4 thickness; a positive value denotes thinning of the measured layer. |
| Reduction in the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score | Before the first treatment session and at the end of the four-week treatment course. | The Turkish QuickDASH questionnaire was used to assess upper-limb symptoms and activity limitations. This 11-item instrument produces a score from 0 to 100, with higher values indicating greater disability. The reduction was calculated as the baseline score minus the week-4 score; a positive value indicates improvement. |
| Reduction in upper-limb pain on the Visual Analog Scale | Before the first treatment session and at the end of the four-week treatment course. | Participants rated pain in the affected upper limb using a Visual Analog Scale scored from 0, indicating no pain, to 10, indicating the most severe pain. Pain reduction was calculated by subtracting the week-4 score from the pretreatment score. Positive values indicate lower pain after treatment. |
| Reduction in the Lymphedema Quality of Life Questionnaire-Arm function domain score | Before the first treatment session and at the end of the four-week treatment course. | The function domain of the Turkish Lymphedema Quality of Life Questionnaire-Arm assessed limitations in daily activities attributable to arm lymphedema. Domain scores range from 1 to 4, with higher scores indicating greater impairment. The baseline domain score minus the week-4 domain score was calculated; positive values indicate improvement. |
| Reduction in the Lymphedema Quality of Life Questionnaire-Arm appearance domain score | Before the first treatment session and at the end of the four-week treatment course. | The appearance domain of the Turkish Lymphedema Quality of Life Questionnaire-Arm assessed the perceived effect of arm lymphedema on appearance. Domain scores range from 1 to 4, with higher scores indicating greater impairment. The baseline domain score minus the week-4 domain score was calculated; positive values indicate improvement. |
| Reduction in the Lymphedema Quality of Life Questionnaire-Arm symptoms domain score | Before the first treatment session and at the end of the four-week treatment course. | The symptoms domain of the Turkish Lymphedema Quality of Life Questionnaire-Arm assessed symptoms associated with arm lymphedema. Domain scores range from 1 to 4, with higher scores indicating greater impairment. The baseline domain score minus the week-4 domain score was calculated; positive values indicate improvement. |
| Reduction in the Lymphedema Quality of Life Questionnaire-Arm mood domain score | Before the first treatment session and at the end of the four-week treatment course. | The mood domain of the Turkish Lymphedema Quality of Life Questionnaire-Arm assessed the emotional impact of arm lymphedema. Domain scores range from 1 to 4, with higher scores indicating greater impairment. The baseline domain score minus the week-4 domain score was calculated; positive values indicate improvement. |
| Increase in active shoulder flexion, abduction, adduction, extension, external rotation, internal rotation | Before the first treatment session and at the end of the four-week treatment course. | Active shoulder flexion, abduction, adduction, extension, external rotation,internal rotation of the affected shoulder were measured in degrees with a standard goniometer by the masked physician. The pretreatment value was subtracted from the week-4 value. A positive result indicates an increase in the available range of motion. |
| Increase in active wrist flexion, extension, radial deviation, ulnar deviation | Before the first treatment session and at the end of the four-week treatment course. | Active flexion, extension, radial deviation,ulnar deviation of the affected wrist were measured in degrees with a standard goniometer by the masked physician. Changes were calculated as the week-4 value minus the pretreatment value. Positive values indicate a gain in range of motion. |
Countries
Turkey (Türkiye)
Outcome results
None listed