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

Study Overview
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Brief Summary
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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.

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

Conditions
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Axillary Web Syndrome

Intervention / Treatment
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* Other: Physical Therapy protocol
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Therapy<br>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<br>* 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.<br>* Other names: PT-AWS;|
| Active Comparator: Control<br>Control protocol includes standard progressive active and action-assisted arm exercises & patient education. | Other: Control<br>* Control protocol includes standard progressive active and action-assisted arm exercises & patient education.<br>* Other names: CG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Axillary web syndrome, cording, physical therapy, breast cancer