Skip to main content
OpenTrials
Completed

NCT Number: NCT02224261

Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Axillary Web Syndrome Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy in women´s health research group. University of Alcalà

Alcalà de Henares, Madrid, 28871, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Therapy protocol

Other

Physical therapy protocol includes 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 "stretching" cords, and patient education.

Other names: PT-AWS

Control

Other

Control protocol includes standard progressive active and action-assisted arm exercises & patient education.

Other names: CG

Primary outcomes

  1. Change from baseline in Subjective pain at one month (post-intervention); and 3 and 6 months post-intervention

    Time frame: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention

    Visual Analogue Scale

Secondary outcomes

  1. Change from baseline in Range of shoulder motion at one month (post-intervention); and 3 and 6 months post-intervention

    Time frame: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention

    Inclinometer

Other outcomes

  1. Change from baseline in QoL related to shoulder pain at one month (post-intervention); and 3 and 6 months post-intervention

    Time frame: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention

    Oxford Shoulder Score

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Collaborators

  • Hospital Universitario Principe de Asturias

Registry information

Official study title

Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial

Acronym: PTaws

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 25, 2014
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.