Effectiveness of Cohesive Bandage on Axillary Web Syndrome After

Study Overview
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Brief Summary
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Objective: To determine the effectiveness of cohesive bandage on the axillary web syndrome in improving pain, reducing swelling and increasing mobility and functionality of the shoulder. Design: randomized single-blinded controlled trial. Follow-up: five physical therapy assessments: pre-intervention; post-intervention, 3 and 6 months post-intervention post-intervention. Participants: 90 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: Control 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 arm therapeutic exercises; Intervention group: progressive active arm therapeutic exercises with cohesive bandage.

Official Title
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Effectiveness of Cohesive Bandage 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: Manual drainage & arm therapeutic exercise
* Other: Cohesive bandaging & arm therapeutic exercise


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 upper limb of the operated side; Consent to participate in the study; No contraindications. 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CONTROL GROUP<br>Control group includes physical therapy protocol 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 arm therapeutic exercises. | Other: Manual drainage & arm therapeutic exercise<br>* See arm/group descriptions.<br>|
| Experimental: COHESIVE BANDAGE GROUP<br>Cohesive bandage is a self-adherent lightweight bandage, made of a porous nonwoven polyester material. A single self-adherent inelastic bandage will be directly applied at full stretch on cleaned and dried skin (10cm 3M CobanTM Minnesota Mining and Manufacturing Co, United States) in a spiral method around the limb, starting at the hand and a layer overlap of 50%, so that the greatest compression was located at the distal points, gradually decreasing toward the proximal shoulder part. Cohesive latex-free bandages will be available for those allergic women. Women will do progressive active arm therapeutic exercises with bandaging. | Other: Cohesive bandaging & arm therapeutic exercise<br>* See arm/group descriptions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Subjective pain | Visual Analogue Scale (0-10 cm) | 4 assessments to evaluate change from baseline: at baseline, after the intervention period (6 weeks from baseline), 3 and 6 months after the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Range of shoulder motion | Inclinometer (measured in grades) | 4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention. | 
| Change from baseline in perceived shoulder disability | Oxford Shoulder Score. The OSS is a unidimensional score comprising 12 questions about pain and disability involving activities of daily routine. Thus, each of the 12 questions is scored from 0 to 4, with 4 representing best outcome/least symptoms. Scores from each question are summed so the overall score run from 0 to 48 with 48 being the best outcome; so that the lower scores indicate more pain and disability. The OSS Spanish version is applicable, reliable, valid, and responsive to assess shoulder disability in Spanish women after breast cancer treatment | 4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention. | 
| Change from baseline in QoL | FACTB+4. Health-related quality of life (HRQoL): HRQoL was measured with the Functional Assessment of Cancer Therapy-Breast (FACT-B) Spanish version 4. FACT-Bv4 is a 40-item questionnaire designed to measure multidimensional HRQoL in women with breast cancer. The 40 items cover four generic scales of well-being (Physical, Emotional, Social, and Functional) and two side-specific subscales: Breast Cancer (9 items) and Arm (4 items). The Arm-specific subscale assesses arm morbidity: 1) pain, 2) poor range of arm movements, 3) numbness, and 4) stiffness. The Breast Cancer subscale plus the arm subscale range from 0 to 56 points. The Trial Outcome Index (TOI) is the sum of Physical and Functional wellbeing plus Breast Cancer Subscale (range 0-92 points). The FACT-B total score can range from 0 to 144, with a higher score indicating better HRQoL. | 4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cohesive bandage, Physical Therapy, Pain