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

NCT04990960 | Completed

• 1 other identifier: 78-2017-SPERIM_ALTRO-MN28
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Axillary Web Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Average abduction

  5 weeks

Study Arms (2)

Physiotherapist

ACTIVE COMPARATOR

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.

Other: Physiotherapy

Self-treatment

EXPERIMENTAL

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

Other: Physiotherapy

Interventions

Physiotherapy 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.

Also known as: Selftreatment

Physiotherapist; Self-treatment

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18years;
• Patients able to sign informed consent;
• Patients who underwent ALND surgery for breast cancer;
• Presence of cords associated with A.W.S.;
• Surgeon examination carried no more than 10 days after the operation.

You may not qualify if:

• \. Presence of cords after AD due to Melanoma metastasis.

Sponsors & Collaborators

• Ospedale "Carlo Poma" - Mantova: lead

Study Sites (1)

Laura Mutti

Mantova, 46100, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Laura Mutti

  Hospital "Carlo Poma" - Mantova - Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: August 5, 2021
• Study Start: October 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: October 30, 2019
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)