Effect of Different Bandage Interface Pressures on Breast Cancer Related Lymphedema

Breast Cancer Lymphedema Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05660590
• Other study ID #: BAIBU-FTR-ED-001
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: May 18, 2022

Study information

• Verified date: December 2022
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 18, 2022
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Edema Arm
• Lymphedema
• Lymphedema of Upper Limb

Intervention

Other:
• 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)

Locations

Country	Name	City	State
Turkey	Abany Izzet Baysal University	Bolu	Center

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)
Primary	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.	baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)
Secondary	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	baseline, 4 weeks, 3 months (follow-up)
Secondary	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.	baseline, 4 weeks, 3 months (follow-up)
Secondary	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	4 weeks