Experimental Study About Physiotherapy Treatment vs Self-treatment In Axillary Web Syndrome After Axillary Dissection

Breast Neoplasms Clinical Trial

Official title:

Experimental Study About Efficacy Of Physiotherapy Treatment vs Self-treatment In Axillary Web Syndrome After Axillary Dissection In Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04990960
• Other study ID #: 78-2017-SPERIM_ALTRO-MN28
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 30, 2019

Study information

• Verified date: August 2021
• Source: Ospedale "Carlo Poma" - Mantova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

BACKGROUND Dissection and removal of Lymph nodes in the Axilla (ALND) remains a method used in breast cancer management across the world. Post- surgical scar tissue that forms in this dissection is therefore beyond the linear scar, is characterized by less elasticity than healthy tissue and can over time, because of the anatomical location, cause significant limitations of the Active Range of Motion (AROM) of the scapulohumeral joint. After this procedure it's possible that Axillary Web Syndrome (AWS) occurs. This study discusses the physiotherapy management of patients with AWS. The primary objective of the study was to verify direct and indirect changes to AWS cords with two treatment methods at a single breast cancer rehabilitation setting: Physiotherapist 's work Vs. Self-treatment.

Description:

Breast cancer is the most common form of cancer among women. Axillary surgical procedures have reported, with post-operative morbidity of bleeding, lymphedema and shoulder pain, also the rather underestimated Axillary Web Syndrome. The study shows that the reduction of the problems linked to the Syndrome such as pain in shoulder Abduction and Flexion and inability in everyday life is possible with an early and competent treatment. Two different approaches to the Syndrome were investigated. The patients were divided in two groups. Good results were obtained within 5 weeks since the appearance of AWS with both of them but if the Physiotherapist is able to teach the convenient exercises, the selftreatment seemed to have the best outcome. This fact can change the awareness that an early approach is necessary inside the path to recovery. In the last years the Axillary Web Syndrome was the topic of many studies: the etiology, its clinical diagnosis, the relation with lymphedema…But the treatment was often reported like a combination of different techniques without indications about kinds, times. Instead the investigators examined a detailed procedure, the same in both groups. The work was different only as regards the cords treatment. This fact shows the value of a comprehensive treatment for neck, shoulder, breast and two different but specific works on the Axillary Web Syndrome. For these reasons its publishing could be important for all the professionals working with women after Surgery for breast cancer and metastatic lymphnodes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Age > 18years;

2. Patients able to sign informed consent;

3. Patients who underwent ALND surgery for breast cancer;

4. Presence of cords associated with A.W.S.;

5. Surgeon examination carried no more than 10 days after the operation.

Exclusion Criteria:

1. Presence of cords after AD due to Melanoma metastasis.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• Physiotherapy
During each session (45 minutes)the patient was assessed and trained in self-treatment exercises assigned to treat their cords. This later method was chosen to ensure regular participation in their exercises and early correction of any inaccuracies in the implementation of the exercises regarding AWS treatment . Or the Physiotherapist worked actively on cords with soft or vigorous stretching.

Locations

Country	Name	City	State
Italy	Laura Mutti	Mantova

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale "Carlo Poma" - Mantova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average flexion	Starting position:the patient is laying on the table with the arm placed on the table and the hand opened touching the side with the palm (0° position).; Flexion: the patient raises the arm towards the headboard (complete at 180°) The movements had been measured with a standard goniometer.	5 weeks
Secondary	Average abduction	Abduction: from the same start-position (0°), the patient moves the arm away from the leg (complete at 180°)	5 weeks