Overview

This trial is active, not recruiting.

Condition axillary web syndrome
Treatments physical therapy protocol, control
Sponsor University of Alcala
Collaborator Hospital Universitario Principe de Asturias
Start date September 2011
End date September 2014
Trial size 80 participants
Trial identifier NCT02224261, 11/032

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: progressive active and action-assisted arm exercises. 9 physical therapy sessions.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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
physical therapy protocol
(Active Comparator)
Control protocol includes same progressive active and action-assisted arm exercises than the experimental group.
control

Primary Outcomes

Measure
Change from baseline in Subjective pain at one month (post-intervention); and 3 and 6 months post-intervention
time frame: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention

Secondary Outcomes

Measure
Change from baseline in Range of shoulder motion at one month (post-intervention); and 3 and 6 months post-intervention
time frame: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention

Eligibility Criteria

Female participants from 18 years up to 70 years old.

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; - 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.

Additional Information

Official title Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by University of Alcala.