Effect of Different Bandage Interface Pressures on Breast Cancer Related Lymphedema
NCT ID: NCT05660590
Last Updated: 2022-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2019-06-01
2022-05-18
Brief Summary
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The main questions it aims to answer are:
* Is high or low bandage pressure effective in reducing edema and soft tissue thickness?
* do bandages applied with high or low bandage pressure comprimise sleep, comfort or subjective benefit from treatment?
Participants will recieve complex decongestive physiotherapy. Bandage will apply high or low pressure. Effects of high and low bandage interface pressures will compare
Detailed Description
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individuals with stage 2 unilateral lymphedema participated in the study. Skin and subcutaneous thicknesses, extremity volumes, sleep quality, treatment benefit, comfort during treatment were evaluated respectively by ultrasound from 6 reference points as dorsum of hand, wrist volar, forearm dorsum, forearm volar, arm dorsum, arm volar, volumetric measurement, Pittsburgh Sleep Quality Index, Patient Benefit Index-Lymphedema, and visual analog scale. Complex decongestive physiotherapy was applied to individuals randomly divided into two groups: low (20-30 mmHg) and high bandage pressure (45-55 mmHg). Individuals were evaluated before treatment, at 1st, 10th session, end of treatment, and at 3 months follow-up.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low bandage pressure
Compression bandages applied with low pressure (20-30 mmHg)
complex decongestive physiotherapy with low pressure compression bandage
both group received complex decongestive physiotherapy consist of manual lymph dranaige, skin care, exercise and compression bandage. Every component except compression bandage applied exacly the same to both group. Compression bandage applied with low bandage interface pressure (20-30 mmHg)
high bandage pressure
Compression bandages applied with low pressure (45-55 mmHg)
complex decongestive physiotherapy with high pressure compression bandage
complex decongestive physiotherapy consist of manual lymph dranaige, skin care, exercise and compression bandage. Every component except compression bandage applied exacly the same to both group. Compression bandage applied with high bandage interface pressure (45-55 mmHg)
Interventions
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complex decongestive physiotherapy with low pressure compression bandage
both group received complex decongestive physiotherapy consist of manual lymph dranaige, skin care, exercise and compression bandage. Every component except compression bandage applied exacly the same to both group. Compression bandage applied with low bandage interface pressure (20-30 mmHg)
complex decongestive physiotherapy with high pressure compression bandage
complex decongestive physiotherapy consist of manual lymph dranaige, skin care, exercise and compression bandage. Every component except compression bandage applied exacly the same to both group. Compression bandage applied with high bandage interface pressure (45-55 mmHg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* To be volunteer.
Exclusion Criteria
* Acute soft tissue infection
* Peripheral artery disease in upper extremity
* Systemic diseases with peripheral edema (kidney, hearth insufficiency etc.),
* Allergy to materials used for treatment
* Mental diseases effect cooperation
* Sensory loss in the effected limb
* Open wound in the effected limb.
18 Years
85 Years
FEMALE
No
Sponsors
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Abant Izzet Baysal University
OTHER
Responsible Party
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Elif Duygu
Research assistant
Principal Investigators
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elif duygu yıldız, Dr
Role: PRINCIPAL_INVESTIGATOR
Abant Izzet Baysal University
Locations
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Abany Izzet Baysal University
Bolu, Center, Turkey (Türkiye)
Countries
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References
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Duygu-Yildiz E, Bakar Y, Hizal M. The effect of complex decongestive physiotherapy applied with different compression pressures on skin and subcutaneous tissue thickness in individuals with breast cancer-related lymphedema: a double-blinded randomized comparison trial. Support Care Cancer. 2023 Jun 7;31(7):383. doi: 10.1007/s00520-023-07843-y.
Other Identifiers
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BAIBU-FTR-ED-001
Identifier Type: -
Identifier Source: org_study_id