Effects of Rehabilitation and Kinesio Taping to Prevent Axillary Web Syndrome After Breast Cancer Surgery

Not Applicable

Completed

• Conditions: Axillary Web Syndrome
• Interventions: Other: Lymphatic drainage; Other: Kinesio taping, Lymphatic drainage

• Registration Number: NCT06269523
• Lead Sponsor: University of Palermo

Brief Summary

Axillary web syndrome (AWS) is a complication associated with breast cancer surgery, characterized by pain, functional limitation of the shoulder and decreased quality of life. There are several physical treatment options to reduce pain and improve the functionality of the upper limb in women with AWS. This study evaluates the effectiveness of an early rehabilitation approach to prevent axillary web syndrome consisting in functional and proprioceptive re-education, manual lymphatic drainage and kinesio taping after breast cancer surgery.

Detailed Description

Axillary web syndrome (AWS), is a complication associated with breast cancer surgery, characterized by pain, functional limitation of the shoulder and decreased quality of life. The pain is localized in the axillary area and along the arm, with the limitation of the glenohumeral joint (GO) and the presence of one or more "cords" of tissue visible or palpable with the abduction of the GO, at the level of the axilla , which can extend medially up to the wrist. Incidence, etiopathogenesis and ideal treatment of this condition are not yet clear.

The literature provides several physical treatment options for AWS. Physical therapy is effective in reducing pain and improving the functionality of the upper limb. Manual lymphatic drainage is indicated in forms of lymphedema due to axillary lymphadenectomy. The commonly used rehabilitation treatment consists of functional re-education of the shoulder, neuromotor and proprioceptive re-education of the upper limb, lymphatic drainage. Kinesio taping is rarely used and not in association with rehabilitation. This study evaluates the effectiveness of an early rehabilitation approach consisting of functional and proprioceptive re-education, manual lymphatic drainage and kinesio taping after quadrantectomy and lymphadenectoma surgery for breast cancer in the prevention of axillary web syndrome.

At the U.O.C. of Functional Recovery and Rehabilitation Department of the Paolo Giaccone University Hospital in Palermo, have been enrolled 18 women between the ages of 45 and 65 years old with a diagnosis of breast cancer, underwent to quadrantectomy and axillary lymphadenectomy.

Patients have been randomly divided into two groups: treatment group, in which kinesio taping has been applied, associated with a rehabilitation protocol lasting 18 sessions of functional and proprioceptive re-education and manual lymphatic drainage; control group, subjected to 18 sessions of functional and proprioceptive re-education, manual lymphatic drainage.

Patients have been evaluated: one week after surgery (T0), at the end of the 18 sessions (T1) and 3 months after surgery (T2).

The investigators evaluated: joint excursion shoulder's degree by a goniometer; the pain, using NRS scale; muscular strength of the upper limbs using a dynamometer (PINCH GAUGE); upper limbs circumference (cyrtometry) by a meter; and the functional capacity of the shoulder, using the Constant Murley scale.

Study Timeline

• Study Start: 2021-07-21
• Primary Completion: 2023-01-31
• Status Verified: 2023-11
• Study Completion: 2024-01-31
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-12
• Last Update Submitted: 2024-02-12
• Study First Posted: 2024-02-21
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

• women between the ages of 45 and 65 years with diagnosis of breast cancer underwent to quadrantectomy and axillary lymphadenectomy.

Exclusion Criteria

• metastatic disease, infections, past TVP, embolia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Lymphatic drainage	18 sessions of functional and proprioceptive re-education and manual lymphatic drainage.
Treatment group	Kinesio taping, Lymphatic drainage	18 sessions of functional and proprioceptive re-education, manual lymphatic drainage associated with kinesio taping.

Primary Outcome Measures

Name	Time	Method
NRS Scale	one week after surgery(T0)- 5 weeks after surgery(T1)-12 weeks after surgery (t2)	NRS scale is an 11-point unidimensional scale that evaluates the intensity of pain in adults.The scale is composed of a horizontal line, with an interval ranging from 0 to 10, corresponding respectively to "no pain" and "worst pain imaginable".
Muscular strength of the upper limbs	one week after surgery(T0)- 5 weeks after surgery(T1) -12 weeks after surgery (t2)	Distal strength can be semiquantitatively measured with a dynamometer. Dynamometry is a more precise measurement of the force that a muscle can exert and can allow for differences in strength to be recorded over time.
Joint excursion shoulder	one week after surgery(T0)-5 weeks after surgery(T1)- 12 weeks after surgery (t2)	Range of motion of the shoulder taken with the use of a goniometer

Secondary Outcome Measures

Name	Time	Method
Constant Murley Score	one week after surgery(T0)- 5 weeks after surgery(T1)-12 weeks after surgery(t2)	The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).The higher the score, the higher the quality of the function.
upper limbs circumferenze (cyrtometry)	one week after surgery(T0)- 5 weeks after surgery(T1)- 12 weeks after surgery (t2)	measurement of the circumference of the upper limb in some points(metacarpophalangeal joint, wrist, elbow, -14 cm from the lateral epicondyle of the elbow, -7 cm from the lateral epicondyle of the elbow), elbow (+7 cm from the lateral epicondyle, +14 cm from the lateral epicondyle) with a measuring tape in centimeters.

Trial Locations

Locations (1)

Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone; 🇮🇹 Palermo, Italy