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

Abant Izzet Baysal University

Status: Completed

Conditions: Breast Cancer Lymphedema; Lymphedema of Upper Limb; Edema Arm

Treatments: Other: complex decongestive physiotherapy with low pressure compression bandage; Other: complex decongestive physiotherapy with high pressure compression bandage

Study type: Interventional

Funder types: Other

Identifiers

NCT05660590

BAIBU-FTR-ED-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

21 participants in 2 patient groups

Low bandage pressure

Active Comparator group

Description:

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

Treatment:

Other: complex decongestive physiotherapy with low pressure compression bandage

high bandage pressure

Active Comparator group

Description:

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

Treatment:

Other: complex decongestive physiotherapy with high pressure compression bandage