---
title: Effect of Different Bandage Interface Pressures on Breast Cancer Related Lymphedema
nct_id: NCT05660590
overall_status: COMPLETED
phase: NA
sponsor: Abant Izzet Baysal University
study_type: INTERVENTIONAL
primary_condition: Lymphedema of Upper Limb
countries: Turkey (Türkiye)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05660590.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05660590"
ct_last_update_post_date: 2022-12-29
last_seen_at: "2026-05-12T06:05:44.414Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT05660590](https://clinicaltrials.gov/study/NCT05660590)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 21
- **Lead Sponsor:** Abant Izzet Baysal University
- **Conditions:** Lymphedema of Upper Limb, Breast Cancer Lymphedema, Edema Arm
- **Start Date:** 2019-06-01
- **Completion Date:** 2022-05-18
- **CT.gov Last Update:** 2022-12-29

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Low bandage pressure** (ACTIVE_COMPARATOR) — Compression bandages applied with low pressure (20-30 mmHg)
- **high bandage pressure** (ACTIVE_COMPARATOR) — Compression bandages applied with low pressure (45-55 mmHg)

## Interventions

- **complex decongestive physiotherapy with low pressure compression bandage** (OTHER) — 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** (OTHER) — 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 Outcomes

- **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.
- **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.

## Secondary Outcomes

- **sleep quality** _(time frame: baseline, 4 weeks, 3 months (follow-up))_
- **Comfort** _(time frame: baseline, 4 weeks, 3 months (follow-up))_
- **Subjective benefit from treatment** _(time frame: 4 weeks)_

## Locations (1)

- Abany Izzet Baysal University, Bolu, Center, Turkey (Türkiye)

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.abany izzet baysal university|bolu|center|turkey (türkiye)` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05660590.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05660590*  
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