Clinical trial NCT02224261: Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery
Official title: Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Axillary Web Syndrome
Keywords: Axillary web syndrome
cording
physical therapy
breast cancer
Lead sponsor: University of Alcala
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Principe de Asturias
First posted: 2014-08-25
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 physical therapy on the axillary web syndrome in improving pain, reducing swelling and increasing mobility of the shoulder. Design: randomized single-blinded controlled trial. Follow-up: five physical therapy assessments: pre-intervention; post-intervention, 3 months post-intervention, 6 months post-intervention. Participants: Eighty 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: Physical Therapy 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 and action-assisted arm exercises; Control group: standard progressive active and action-assisted arm exercises. 9 physical therapy sessions.


Eligibility criteria: Inclusion Criteria:

* Unilateral breast cancer;
* Breast surgery with lymphadenectomy and / or sentinel lymph node biopsy;
* Axillary web syndrome in chest and / or upper limb of the operated side;
* VAS\>3
* Consent to participate in the study;
* No contraindications for physical therapy (infection, metastasis);

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 at one month (post-intervention); and 3 and 6 months post-intervention
timeFrame: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
Secondary outcomes:
measure: Change from baseline in Range of shoulder motion at one month (post-intervention); and 3 and 6 months post-intervention
timeFrame: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
Other outcomes:
measure: Change from baseline in QoL related to shoulder pain at one month (post-intervention); and 3 and 6 months post-intervention
timeFrame: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
Locations:
city: Alcalà de Henares
country: Spain
facility: Physiotherapy in women´s health research group. University of Alcalà
state: Madrid
Study officials:
References:
citation: Torres Lacomba M, Mayoral Del Moral O, Coperias Zazo JL, Yuste Sanchez MJ, Ferrandez JC, Zapico Goni A. Axillary web syndrome after axillary dissection in breast cancer: a prospective study. Breast Cancer Res Treat. 2009 Oct;117(3):625-30. doi: 10.1007/s10549-009-0371-8. Epub 2009 Mar 21.
citation: Torres-Lacomba M, Prieto-Gomez V, Arranz-Martin B, Ferrandez JC, Yuste-Sanchez MJ, Navarro-Brazalez B, Romay-Barrero H. Manual Lymph Drainage With Progressive Arm Exercises for Axillary Web Syndrome After Breast Cancer Surgery: A Randomized Controlled Trial. Phys Ther. 2022 Mar 1;102(3):pzab314. doi: 10.1093/ptj/pzab314.