Clinical trial NCT05660590: Effect of Different Bandage Interface Pressures on Breast Cancer Related Lymphedema
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema of Upper Limb
Breast Cancer Lymphedema
Edema Arm
Keywords: compelex decongestive physiotherapy
bandage interface pressure
compression therapy
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised comparison trial
Primary purpose: TREATMENT

Brief summary: The goal of this randomised comparison study is to compare different bandage interface pressures in individuals with breast cancer related lymphedema

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: The aim of this study was to evaluate the effect of compression bandage applied with different pressures on skin and subcutaneous thickness in individuals with breast cancer-related lymphedema.

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.

Eligibility criteria: Inclusion Criteria:

* Stage 2 unilateral BCRL involving whole extremity according to ISL
* To be volunteer.

Exclusion Criteria:

* Acute deep vein thrombosis
* 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.

Primary outcomes:
measure: change from baseline skin and subcutanetous thickness with 4 weeks treatment and follow up
timeFrame: baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)
measure: change from baseline residual volume with 4 weeks treatment and follow up
timeFrame: baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)
Secondary outcomes:
measure: sleep quality
timeFrame: baseline, 4 weeks, 3 months (follow-up)
measure: Comfort
timeFrame: baseline, 4 weeks, 3 months (follow-up)
measure: Subjective benefit from treatment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abany Izzet Baysal University
state: Center
Study officials:
affiliation: Abant Izzet Baysal University
name: elif duygu yıldız, Dr
role: PRINCIPAL_INVESTIGATOR
References: