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

NCT ID: NCT04990960

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-10-30

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physiotherapist

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.

Group Type: ACTIVE_COMPARATOR

Physiotherapy

Intervention Type: OTHER

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.

Self-treatment

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

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Selftreatment

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ospedale "Carlo Poma" - Mantova

OTHER

Sponsor Role: lead

Responsible Party

Laura Mutti

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Mutti

Role: PRINCIPAL_INVESTIGATOR

Hospital "Carlo Poma" - Mantova - Italy

Locations

Laura Mutti

Mantova, , Italy

Countries

Italy

Other Identifiers

78-2017-SPERIM_ALTRO-MN28

Identifier Type: -

Identifier Source: org_study_id