Clinical trial NCT07024134: Recovery Optimization: Adding Tissue Flossing to Nerve Glide on Axillary Web Syndrome Post Mastectomy
Official title: Recovery Optimization: Adding Tissue Flossing to Nerve Glide on Axillary Web Syndrome Post Mastectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Axillary Web Syndrome
Keywords: mastectomy
nerve glide
tissue flossing
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 155
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

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: Tissue flossing for the upper limb involves wrapping a floss band, typically made of elastic material, around the targeted area to provide compression and create a shearing effect on the tissue. This technique is utilized to enhance mobility, reduce pain, and improve recovery. The procedure begins by wrapping the band around the upper limb, starting from the distal part of the limb and moving proximally, ensuring a snug but not overly tight application that allows for some movement. The band is usually left in place for approximately 2-3 minutes. Physiologically, Tissue flossing for the upper limb, often referred to as compression wrapping, plays a significant role in enhancing physiological functions by improving joint mobility and reducing pain. This technique involves tightly wrapping a stretchable band around a muscle or joint to create compression. The compression temporarily restricts blood flow, which, upon release, results in a rush of blood back to the tissues. This process enhances circulation, promoting nutrient delivery and waste removal from the affected area.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 45 and 65 years with diagnosis of breast cancer underwent to quadrantectomy and axillary lymphadenectomy.
* No change of arm size.
* Females only will participate in the study.
* All patients have axillary web syndrome
* All patients' relatives enrolled to the study will have their informed consent

Exclusion Criteria:

* Metastatic disease, infections, past TVP, emboli.
* Lymphedema.
* Chemotherapy and Radiotherapy.
* Pregnant women.
* Patients who suffer from mental or psychological problems.
* Patients who have psoriasis, liver disease, diabetes mellitus, hypertensive patients and cardiac -robleme
* Patients have Genetic disease or deformity
* Who has previous injury or fracture in shoulder joint
* Rheumatoid arthritis
* Osteopenia
* Frozen shoulder
* metastases of any kind
* lymphedema,
* a traumatic injury to the targeted upper extremity
* a musculoskeletal disorder
* taking any anticoagulants
* had undergone bilateral breast cancer surgery
* experienced locoregional recurrence
* had vascular problems in the affected upper extremity

Primary outcomes:
measure: Shoulder Pain. Visual Analogic Scale (VAS):
timeFrame: at baseline and at 12 weeks
measure: axillary cord thickness
timeFrame: at baseline and at 12 weeks
Secondary outcomes:
measure: Shoulder Range of Movement (flexion, extension, abduction and external and internal rotation)
timeFrame: at baseline and at 12 weeks
measure: Quality of life. Barthel Scale:
timeFrame: at baseline and at 12 weeks
Other outcomes:
Locations:
Study officials:
References: