Clinical trial NCT06269523: Effects of Rehabilitation and Kinesio Taping to Prevent Axillary Web Syndrome After Breast Cancer Surgery
Official title: Effects of Rehabilitation and Kinesio Taping to Prevent Axillary Web Syndrome After Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Axillary Web Syndrome
Keywords: Axillary Web Syndrome
Kinesio taping
Lymphatic drainage
Breast cancer surgery
Proprioceptive re-education
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 18
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: NRS Scale
timeFrame: one week after surgery(T0)- 5 weeks after surgery(T1)-12 weeks after surgery (t2)
measure: Joint excursion shoulder
timeFrame: one week after surgery(T0)-5 weeks after surgery(T1)- 12 weeks after surgery (t2)
measure: Muscular strength of the upper limbs
timeFrame: one week after surgery(T0)- 5 weeks after surgery(T1) -12 weeks after surgery (t2)
Secondary outcomes:
measure: Constant Murley Score
timeFrame: one week after surgery(T0)- 5 weeks after surgery(T1)-12 weeks after surgery(t2)
measure: upper limbs circumferenze (cyrtometry)
timeFrame: one week after surgery(T0)- 5 weeks after surgery(T1)- 12 weeks after surgery (t2)
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
Study officials:
References:
citation: Moskovitz AH, Anderson BO, Yeung RS, Byrd DR, Lawton TJ, Moe RE. Axillary web syndrome after axillary dissection. Am J Surg. 2001 May;181(5):434-9. doi: 10.1016/s0002-9610(01)00602-x.
citation: Agostini F, Attanasi C, Bernetti A, Mangone M, Paoloni M, Del Monte E, Mammucari M, Maggiori E, Russo D, Marzo RD, Migliore A, Paolucci T. Web Axillary Pain Syndrome-Literature Evidence and Novel Rehabilitative Suggestions: A Narrative Review. Int J Environ Res Public Health. 2021 Oct 2;18(19):10383. doi: 10.3390/ijerph181910383.
citation: Dinas K, Kalder M, Zepiridis L, Mavromatidis G, Pratilas G. Axillary web syndrome: Incidence, pathogenesis, and management. Curr Probl Cancer. 2019 Dec;43(6):100470. doi: 10.1016/j.currproblcancer.2019.02.002. Epub 2019 Mar 15.
citation: Ezzo J, Manheimer E, McNeely ML, Howell DM, Weiss R, Johansson KI, Bao T, Bily L, Tuppo CM, Williams AF, Karadibak D. Manual lymphatic drainage for lymphedema following breast cancer treatment. Cochrane Database Syst Rev. 2015 May 21;2015(5):CD003475. doi: 10.1002/14651858.CD003475.pub2.
citation: Kasawara KT, Mapa JMR, Ferreira V, Added MAN, Shiwa SR, Carvas N Jr, Batista PA. Effects of Kinesio Taping on breast cancer-related lymphedema: A meta-analysis in clinical trials. Physiother Theory Pract. 2018 May;34(5):337-345. doi: 10.1080/09593985.2017.1419522. Epub 2018 Jan 8.