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

NCT02224261 | Completed DMC

• 1 other identifier: 11/032
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Axillary Web Syndrome

Keywords

Axillary web syndrome; cording; physical therapy; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

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

Other Outcomes (1)

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

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

Study Arms (2)

Physical Therapy

EXPERIMENTAL

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: Physical Therapy protocol

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

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.

Also known as: PT-AWS

Physical Therapy

Control OTHER

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

Also known as: CG

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

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

Sponsors & Collaborators

• University of Alcala: lead
• Hospital Universitario Principe de Asturias: collaborator

Study Sites (1)

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

Alcalà de Henares, Madrid, 28871, Spain

Location

Related 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.

  PMID: 19306057 BACKGROUND

• 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.

  PMID: 35079831 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 25, 2014
• Study Start: January 10, 2016
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

ES (1)