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

NCT ID: NCT02224261

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-10
• Study Completion Date: 2019-12-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical Therapy

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.

Group Type: EXPERIMENTAL

Physical Therapy protocol

Intervention Type: 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.

Control

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

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Control

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

Intervention Type: OTHER

Other Intervention Names

PT-AWS; CG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Principe de Asturias

OTHER

Sponsor Role: collaborator

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Maria Torres Lacomba

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Alcalà de Henares, Madrid, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 19306057 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35079831 (View on PubMed)

Other Identifiers

11/032

Identifier Type: -

Identifier Source: org_study_id