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

Not Applicable

Completed

• Conditions: Breast Neoplasms
• Interventions: Other: Physiotherapy

• Registration Number: NCT04990960
• Lead Sponsor: Ospedale "Carlo Poma" - Mantova

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-10-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-10-30
• Study First Submitted: 2021-04-28
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-02
• Last Update Submitted: 2021-08-02
• Study First Posted: 2021-08-05
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-treatment	Physiotherapy	The Physiotherapist worked on adhered breast scars, stiffness in neck and arm movements. During each session the patient was also assessed and trained in self-treatment exercises assigned to treat their cords. Subjects were trained to perform self-treatment extension exercises with four exercises selected by the Physiotherapist
Physiotherapist	Physiotherapy	The Physiotherapist worked on adhered breast scars, stiffness in neck and arm movements and actively worked on AWS cords with gentle extensions and / or energetic detachment maneuvers. No self-treatment methods were offered and required of the subject.

Primary Outcome Measures

Name	Time	Method
Average flexion	5 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Average abduction	5 weeks	Abduction: from the same start-position (0°), the patient moves the arm away from the leg (complete at 180°)

Trial Locations

Locations (1)

Laura Mutti; 🇮🇹 Mantova, Italy