Clinical trial NCT04990960: Experimental Study About Physiotherapy Treatment vs Self-treatment In Axillary Web Syndrome After Axillary Dissection
Official title: Experimental Study About Efficacy Of Physiotherapy Treatment vs Self-treatment In Axillary Web Syndrome After Axillary Dissection In Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Axillary Web Syndrome
Lead sponsor: Ospedale "Carlo Poma" - Mantova
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 19
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Average flexion
timeFrame: 5 weeks
Secondary outcomes:
measure: Average abduction
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Mantova
country: Italy
facility: Laura Mutti
Study officials:
affiliation: Hospital "Carlo Poma" - Mantova - Italy
name: Laura Mutti
role: PRINCIPAL_INVESTIGATOR
References: