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Clinical Trials/NCT05660590
NCT05660590
Completed
Not Applicable

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

Abant Izzet Baysal University1 site in 1 country21 target enrollmentJune 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lymphedema of Upper Limb
Sponsor
Abant Izzet Baysal University
Enrollment
21
Locations
1
Primary Endpoint
change from baseline residual volume with 4 weeks treatment and follow up
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
May 18, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elif Duygu

Research assistant

Abant Izzet Baysal University

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.

Outcomes

Primary Outcomes

change from baseline residual volume with 4 weeks treatment and follow up

Time Frame: baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)

Limb volume was determined by the overflowing water method. The volumetric vessel was filled with tap water up to the overflow point of the vessel. Subjects were asked to lean forward while standing and slowly dip their arms into the water until the bar at the base of the volumetric cup snapped between the 2nd and 3rd fingers. During immersion, he was asked to avoid movements that could increase the transport of water. The overflowing water was first taken into a container. Then, the overflow water was calculated by transferring it to the measuring cups. The amount of overflowing water was recorded in ml. Measurements were made bilaterally.

change from baseline skin and subcutanetous thickness with 4 weeks treatment and follow up

Time Frame: baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)

Evaluation of skin and subcutaneous tissue thickness and US evaluations were made by a radiologist using a 6-15 MHz linear probe with a LOGIQ US system. Skin and subcutaneous thickness were recorded as milimeter.

Secondary Outcomes

  • sleep quality(baseline, 4 weeks, 3 months (follow-up))
  • Comfort(baseline, 4 weeks, 3 months (follow-up))
  • Subjective benefit from treatment(4 weeks)

Study Sites (1)

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