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

Axillary Web Syndrome Clinical Trial

— PTaws  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224261
• Other study ID #: 11/032
• Status: Completed
• Phase: N/A
• Start date: January 10, 2016
• Est. completion date: December 10, 2019

Study information

• Verified date: September 2023
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Axillary Web Syndrome
• Syndrome

Intervention

Other:
• Physical Therapy protocol
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.
• Control
Control protocol includes standard progressive active and action-assisted arm exercises & patient education.

Locations

Country	Name	City	State
Spain	Physiotherapy in women´s health research group. University of Alcalà	Alcalà de Henares	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
University of Alcala	Hospital Universitario Principe de Asturias

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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 Tri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in QoL related to shoulder pain at one month (post-intervention); and 3 and 6 months post-intervention	Oxford Shoulder Score	Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
Primary	Change from baseline in Subjective pain at one month (post-intervention); and 3 and 6 months post-intervention	Visual Analogue Scale	Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
Secondary	Change from baseline in Range of shoulder motion at one month (post-intervention); and 3 and 6 months post-intervention	Inclinometer	Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention