Effectiveness of Cohesive Bandage on Axillary Web Syndrome After
- Conditions
- Axillary Web Syndrome
- Interventions
- Other: Cohesive bandaging & arm therapeutic exerciseOther: Manual drainage & arm therapeutic exercise
- Registration Number
- NCT04338334
- Lead Sponsor
- University of Alcala
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 90
- 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.
- Cognitive impairment;
- Visual impairment for reading;
- Lymphedema;
- Bilateral breast cancer;
- Systemic disease (metastases),
- Infection;
- Locoregional recurrence.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COHESIVE BANDAGE GROUP Cohesive bandaging & arm therapeutic exercise 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. CONTROL GROUP Manual drainage & arm therapeutic exercise 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.
- Primary Outcome Measures
Name Time Method Change from baseline in Subjective pain 4 assessments to evaluate change from baseline: at baseline, after the intervention period (6 weeks from baseline), 3 and 6 months after the intervention. Visual Analogue Scale (0-10 cm)
- Secondary Outcome Measures
Name Time Method Change from baseline in perceived shoulder disability 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. 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
Change from baseline in Range of shoulder motion 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. Inclinometer (measured in grades)
Change from baseline in QoL 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. 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.
Trial Locations
- Locations (1)
María Torres-Lacomba
🇪🇸Alcalá De Henares, Madrid, Spain