Clinical trial NCT04338334: Effectiveness of Cohesive Bandage on Axillary Web Syndrome After
Official title: Effectiveness of Cohesive Bandage on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Axillary Web Syndrome
Keywords: Cohesive bandage
Physical Therapy
Pain
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To determine the effectiveness of cohesive bandage on the axillary web syndrome in improving pain, reducing swelling and increasing mobility and functionality of the shoulder. Design: randomized single-blinded controlled trial. Follow-up: five physical therapy assessments: pre-intervention; post-intervention, 3 and 6 months post-intervention post-intervention. Participants: 90 consecutive women diagnosed with axillary web syndrome after undergoing unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two groups by EpiData 3.1 software. Interventions: Control group: Physical Therapy composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active arm therapeutic exercises; Intervention group: progressive active arm therapeutic exercises with cohesive bandage.


Eligibility criteria: Inclusion Criteria:

* Unilateral breast cancer;
* Breast surgery with lymphadenectomy and / or sentinel lymph node biopsy;
* Axillary web syndrome in upper limb of the operated side;
* Consent to participate in the study;
* No contraindications.

Exclusion Criteria:

* Cognitive impairment;
* Visual impairment for reading;
* Lymphedema;
* Bilateral breast cancer;
* Systemic disease (metastases),
* Infection;
* Locoregional recurrence.

Primary outcomes:
measure: Change from baseline in Subjective pain
timeFrame: 4 assessments to evaluate change from baseline: at baseline, after the intervention period (6 weeks from baseline), 3 and 6 months after the intervention.
Secondary outcomes:
measure: Change from baseline in Range of shoulder motion
timeFrame: 4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.
measure: Change from baseline in perceived shoulder disability
timeFrame: 4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.
measure: Change from baseline in QoL
timeFrame: 4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: María Torres-Lacomba
state: Madrid
Study officials:
affiliation: University of Alcalá
name: María Torres-Lacomba, PhD
role: PRINCIPAL_INVESTIGATOR
References: