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

Primary Purpose

Axillary Web Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical Therapy protocol
Control
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axillary Web Syndrome focused on measuring Axillary web syndrome, cording, physical therapy, breast cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical Therapy

Control

Arm Description

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

Outcomes

Primary Outcome Measures

Change from baseline in Subjective pain at one month (post-intervention); and 3 and 6 months post-intervention
Visual Analogue Scale

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2014
Last Updated
September 25, 2023
Sponsor
University of Alcala
Collaborators
Hospital Universitario Principe de Asturias
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1. Study Identification

Unique Protocol Identification Number
NCT02224261
Brief Title
Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery
Acronym
PTaws
Official Title
Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2016 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
Collaborators
Hospital Universitario Principe de Asturias

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axillary Web Syndrome
Keywords
Axillary web syndrome, cording, physical therapy, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control protocol includes standard progressive active and action-assisted arm exercises & patient education.
Intervention Type
Other
Intervention Name(s)
Physical Therapy protocol
Other Intervention Name(s)
PT-AWS
Intervention Description
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
Intervention Name(s)
Control
Other Intervention Name(s)
CG
Intervention Description
Control protocol includes standard progressive active and action-assisted arm exercises & patient education.
Primary Outcome Measure Information:
Title
Change from baseline in Subjective pain at one month (post-intervention); and 3 and 6 months post-intervention
Description
Visual Analogue Scale
Time Frame
Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
Secondary Outcome Measure Information:
Title
Change from baseline in Range of shoulder motion at one month (post-intervention); and 3 and 6 months post-intervention
Description
Inclinometer
Time Frame
Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
Other Pre-specified Outcome Measures:
Title
Change from baseline in QoL related to shoulder pain at one month (post-intervention); and 3 and 6 months post-intervention
Description
Oxford Shoulder Score
Time Frame
Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Physiotherapy in women´s health research group. University of Alcalà
City
Alcalà de Henares
State/Province
Madrid
ZIP/Postal Code
28871
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19306057
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.
Results Reference
background
PubMed Identifier
35079831
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.
Results Reference
result

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

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