Assessing Efficacy of Axillary Web Syndrome Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Range of motion change overtime
Study Overview
Brief Summary
The aim of this study is verify the effectiveness of manual maneuver associated with stretching exercises in the treatment of Axillary Web Syndrome.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Manual manoeuver + stretching
Patients will receive a manual manoeuver treatment and education to perform stretching exercises at home.
Intervention: Manual manoeuver + stretching (Other)
stretching exercise
Patients will receive education to perform stretching exercises at home.
Intervention: stretching exercise (Other)
Outcomes
Primary Outcomes
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
- Lymphedema assessment(3 years after baseline measure)