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

Not Applicable

Completed

• Conditions: Axillary Web Syndrome
• Interventions: Other: Control; Other: Physical Therapy protocol

• Registration Number: NCT02224261
• Lead Sponsor: University of Alcala

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-25
• Study Start: 2016-01-10
• Primary Completion: 2019-12-10
• Study Completion: 2019-12-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Control protocol includes standard progressive active and action-assisted arm exercises \& patient education.
Physical Therapy	Physical Therapy protocol	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Physiotherapy in women´s health research group. University of Alcalà; 🇪🇸 Alcalà de Henares, Madrid, Spain