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Effect of Different Bandage Interface Pressures on Breast Cancer Related Lymphedema (BCRL)

Primary Purpose

Lymphedema of Upper Limb, Breast Cancer Lymphedema, Edema Arm

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
complex decongestive physiotherapy with low pressure compression bandage
complex decongestive physiotherapy with high pressure compression bandage
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema of Upper Limb focused on measuring compelex decongestive physiotherapy, bandage interface pressure, compression therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Abany Izzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low bandage pressure

high bandage pressure

Arm Description

Compression bandages applied with low pressure (20-30 mmHg)

Compression bandages applied with low pressure (45-55 mmHg)

Outcomes

Primary Outcome Measures

change from baseline skin and subcutanetous thickness with 4 weeks treatment and 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.
change from baseline residual volume with 4 weeks treatment and 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.

Secondary Outcome Measures

sleep quality
Sleep quality was assessed with the Pittsburgh Sleep Quality Index (PSQI). The scale that determines sleep quality consists of 18 questions and evaluates sleep quality in the last four weeks. PSQI has 7 components, and each component is evaluated between 0-3 points. The total score ranges from 0-21 (206). A total score higher than 5 indicates poor sleep quality (28). The sub-dimensions of PSQI are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction
Comfort
Patient comfort was evaluated with Visual Analogue Scale at the end of the treatment. It was explained to the individual that 0 point of a 10 cm line represents minimum comfort and 10 point represents maximum comfort. The individual was asked to mark the level of comfort he perceived during the treatment. The point marked by the individual was measured with a ruler and recorded in cm.
Subjective benefit from treatment
The benefit from the treatment was evaluated with the Patient Benefit Index-Lymphedema. It consists of two five-point Likert-type questionnaires containing the same 23 questions, the Patient Needs Questionnaire, and the Patient Benefit Questionnaire. Scores of Index are between 0-4. "0" means no benefit from treatment. "4" means maximum benefit from treatment. score

Full Information

First Posted
December 2, 2022
Last Updated
December 26, 2022
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT05660590
Brief Title
Effect of Different Bandage Interface Pressures on Breast Cancer Related Lymphedema
Acronym
BCRL
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
May 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Upper Limb, Breast Cancer Lymphedema, Edema Arm
Keywords
compelex decongestive physiotherapy, bandage interface pressure, compression therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised comparison trial
Masking
ParticipantOutcomes Assessor
Masking Description
radiologist who assessed soft tissue thickness assessment is masked and the patients did't know which group they belong to.
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low bandage pressure
Arm Type
Active Comparator
Arm Description
Compression bandages applied with low pressure (20-30 mmHg)
Arm Title
high bandage pressure
Arm Type
Active Comparator
Arm Description
Compression bandages applied with low pressure (45-55 mmHg)
Intervention Type
Other
Intervention Name(s)
complex decongestive physiotherapy with low pressure compression bandage
Other Intervention Name(s)
Low bandage interface pressure
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
complex decongestive physiotherapy with high pressure compression bandage
Other Intervention Name(s)
High bandage interface pressure
Intervention Description
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)
Primary Outcome Measure Information:
Title
change from baseline skin and subcutanetous thickness with 4 weeks treatment and follow up
Description
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.
Time Frame
baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)
Title
change from baseline residual volume with 4 weeks treatment and follow up
Description
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.
Time Frame
baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)
Secondary Outcome Measure Information:
Title
sleep quality
Description
Sleep quality was assessed with the Pittsburgh Sleep Quality Index (PSQI). The scale that determines sleep quality consists of 18 questions and evaluates sleep quality in the last four weeks. PSQI has 7 components, and each component is evaluated between 0-3 points. The total score ranges from 0-21 (206). A total score higher than 5 indicates poor sleep quality (28). The sub-dimensions of PSQI are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction
Time Frame
baseline, 4 weeks, 3 months (follow-up)
Title
Comfort
Description
Patient comfort was evaluated with Visual Analogue Scale at the end of the treatment. It was explained to the individual that 0 point of a 10 cm line represents minimum comfort and 10 point represents maximum comfort. The individual was asked to mark the level of comfort he perceived during the treatment. The point marked by the individual was measured with a ruler and recorded in cm.
Time Frame
baseline, 4 weeks, 3 months (follow-up)
Title
Subjective benefit from treatment
Description
The benefit from the treatment was evaluated with the Patient Benefit Index-Lymphedema. It consists of two five-point Likert-type questionnaires containing the same 23 questions, the Patient Needs Questionnaire, and the Patient Benefit Questionnaire. Scores of Index are between 0-4. "0" means no benefit from treatment. "4" means maximum benefit from treatment. score
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
elif duygu yıldız, Dr
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abany Izzet Baysal University
City
Bolu
State/Province
Center
ZIP/Postal Code
14030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Different Bandage Interface Pressures on Breast Cancer Related Lymphedema

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