Axillary Web Syndrome
Conditions
Keywords
Axillary web syndrome, cording, physical therapy, breast cancer
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.
Interventions
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.
OTHERControl
Control protocol includes standard progressive active and action-assisted arm exercises & patient education.
Sponsors
Hospital Universitario Principe de Asturias
University of Alcala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Subjective 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 | Visual Analogue Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Inclinometer |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | Oxford Shoulder Score |
Countries
Spain
Outcome results
None listed