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Completed

NCT Number: NCT03284008

Assessing Efficacy of Axillary Web Syndrome Treatment

The aim of this study is verify the effectiveness of manual maneuver associated with stretching exercises in the treatment of Axillary Web Syndrome.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Europeo di Oncologia

Milan, Lombardy, 20141, Italy

About this study

Axillary Web Syndrome (AWS) is one of the short / medium-term sequela of surgical treatment for breast cancer with axillary dissection (AD) or sentinel lymph node biopsy (SLNB), with incidence reported in literature between 28% and 72%. AWS could be described as a thrombophlebitis of veno-lymph vessels due to a trauma of the region subjected to surgery, with the same characteristics of "Mondor's disease" diagnosed in post-traumatic and surgical areas where is a large presence of veno-lymphatic capillaries.

The syndrome onset occur in approximately 2-4 weeks after the surgery and its complete regression happen in 3-6 months after the onset. The clinical signs frequently described are pain and tension during movement in the axillary region, elbow, forearm and wrist, following the arm lymphatic pathway. Moreover, patients report difficulties in moving the arm into activities that require a moderate range of motion and could feel and see in the affected arm cords similar to a tendon. Even if the impairment can cause disability for a limited period of time, rehabilitation is usually advice to prevent further complications such as frozen shoulder, articular impeachment syndrome and long-term chronic pain, complications that could worsen patient's quality of life with a significant increase in costs and time to recovery.

Nowadays there are no studies in the literature that demonstrate the effectiveness of physiotherapy in AWS, with just case reports describing different treatments techniques, without a scientifically defined experimented rehabilitation protocol.

This experimental, monocentric, randomized clinical trial wants verify the effectiveness of a manual maneuver associated with stretching exercises in the treatment of AWS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients with age between 18 and 70 years old
  • Axillary dissection with or without plastic reconstruction with prothesis
  • Positive diagnose of axillary web syndrome.
  • Patients without mental or psychological problems which could affect the proposed treatment execution.
  • Signed informed consensus form.

Exclusion criteria

  • Chronic or acute upper limb pathology which could affect the proposed treatment execution.
  • Patients with mental or psychological problems which could affect the proposed treatment execution.
  • Plastic reconstruction with abdominal (DIEP or TRAM) and dorsal grafts or with expander.
  • Previous head and neck, sentinel lymph node biopsy or axillary dissection surgery.
  • Previous breast, axillary or head and neck radiotherapy.
  • Halsted mastectomy.
  • Previous lymphedema.
  • Bilateral axillary dissection surgery
  • Physiotherapy treatment execute outside hospital during the study.

Treatment and study plan

Manual manoeuver + stretching

Other

Patients in experimental group will receive, after AWS diagnose, a manual manoeuver to snap the cord, follow by a demonstration and education of the exercise to be made at home.

stretching exercise

Other

Patients in control group will receive, after AWS diagnose, just a demonstration and education of the exercise to be made at home.

Primary outcomes

  1. Range of motion change overtime

    Time frame: Baseline, 7 days and 30 days after baseline measure

    Range of motion measured with a handheld goniometer, in degrees.

Secondary outcomes

  1. Lymphedema assessment

    Time frame: 3 years after baseline measure

    Lymphedema measured with centimetric and constant dielectric method

Other outcomes

  1. Pain change overtime

    Time frame: Baseline, 7 days and 30 days after baseline measure

    Pain measured with 0-10 numeric rate scale

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Collaborators

  • Fondazione Umberto Veronesi

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2019
First posted
Sep 15, 2017
Registry last updated
Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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