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| Name | Class |
|---|---|
| Fondazione Umberto Veronesi | OTHER |
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The aim of this study is verify the effectiveness of manual maneuver associated with stretching exercises in the treatment of Axillary Web Syndrome.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual manoeuver + stretching | Experimental | Patients will receive a manual manoeuver treatment and education to perform stretching exercises at home. |
|
| stretching exercise | Active Comparator | Patients will receive education to perform stretching exercises at home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Range of motion change overtime | Range of motion measured with a handheld goniometer, in degrees. | Baseline, 7 days and 30 days after baseline measure |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphedema assessment | Lymphedema measured with centimetric and constant dielectric method | 3 years after baseline measure |
| Measure | Description | Time Frame |
|---|---|---|
| Pain change overtime | Pain measured with 0-10 numeric rate scale | Baseline, 7 days and 30 days after baseline measure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabio Sandrin | European Institute of Oncolgy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Europeo di Oncologia | Milan | Lombardy | 20141 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21987036 | Background | Bergmann A, Mendes VV, de Almeida Dias R, do Amaral E Silva B, da Costa Leite Ferreira MG, Fabro EA. Incidence and risk factors for axillary web syndrome after breast cancer surgery. Breast Cancer Res Treat. 2012 Feb;131(3):987-92. doi: 10.1007/s10549-011-1805-7. Epub 2011 Oct 11. | |
| 17457830 | Background | Cheville AL, Tchou J. Barriers to rehabilitation following surgery for primary breast cancer. J Surg Oncol. 2007 Apr 1;95(5):409-18. doi: 10.1002/jso.20782. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| 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. |
|
| 27704260 | Background | Wariss BR, Costa RM, Pereira AC, Koifman RJ, Bergmann A. Axillary web syndrome is not a risk factor for lymphoedema after 10 years of follow-up. Support Care Cancer. 2017 Feb;25(2):465-470. doi: 10.1007/s00520-016-3424-7. Epub 2016 Oct 4. |
| 19306057 | Background | Torres Lacomba M, Mayoral Del Moral O, Coperias Zazo JL, Yuste Sanchez MJ, Ferrandez JC, Zapico Goni A. Axillary web syndrome after axillary dissection in breast cancer: a prospective study. Breast Cancer Res Treat. 2009 Oct;117(3):625-30. doi: 10.1007/s10549-009-0371-8. Epub 2009 Mar 21. |
| 11448437 | Background | Moskovitz AH, Anderson BO, Yeung RS, Byrd DR, Lawton TJ, Moe RE. Axillary web syndrome after axillary dissection. Am J Surg. 2001 May;181(5):434-9. doi: 10.1016/s0002-9610(01)00602-x. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |