NCT07024134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 10, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2025

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

June 9, 2025

Last Update Submit

December 5, 2025

Conditions

Keywords

mastectomynerve glidetissue flossing

Outcome Measures

Primary Outcomes (2)

  • Shoulder Pain. Visual Analogic Scale (VAS):

    According to the National Cancer Institute (NIH), it is a tool used to help the professional assess the intensity of certain sensations and feelings, such as pain. The Visual Analog Scale in Arabic version for pain is composed of a straight line on which an extreme means no pain and the other extreme means the worst pain imaginable.

    at baseline and at 12 weeks

  • axillary cord thickness

    Ultrasonography, this device will be used for the assessment of axillary cord thickness, echogenicity and disorganization. One technique used in ultrasonography is utilizing a high-resolution ultrasound system with 18 MHz frequency, which provides high-definition superficial imaging. A gel technique is also used to reduce artifacts caused by tissue compression. This technique can be used to measure cord thickness, echogenicity, and disorganization.

    at baseline and at 12 weeks

Secondary Outcomes (2)

  • Shoulder Range of Movement (flexion, extension, abduction and external and internal rotation)

    at baseline and at 12 weeks

  • Quality of life. Barthel Scale:

    at baseline and at 12 weeks

Study Arms (4)

Shoulder flossing with ROM exercises

EXPERIMENTAL
Other: Shoulder flossing application

Nerve Glide exercises

EXPERIMENTAL
Other: Nerve glide application

Shoulder flossing with Nerve Glide

EXPERIMENTAL
Other: Shoulder flossing with Nerve Glide

Control group

NO INTERVENTION

Interventions

Select a floss band, typically made of latex, which is about 1-2 inches wide. Ensure the area to be wrapped is clean and dry to prevent slipping. Begin wrapping the floss band around the upper arm, just below the shoulder joint. Start at the deltoid's base. Leave about 2 inches of the band free at the start to tuck in the end when you finish wrapping. Wrap the band tightly but not to the point of causing discomfort or cutting off circulation, the band should be snug but not so tight that it causes numbness or tingling. Aim for about a 50% stretch of the band as you wrap. Continue wrapping down the arm, covering the entire upper arm and ending just above the elbow Overlap each layer by about 50% to ensure even coverage and compression. Once you reach the desired coverage area, tuck the end of the band under the last loop to secure it. Check the tightness to ensure it is snug but not overly constrictive.

Shoulder flossing with ROM exercises

With the band in place, perform slow and controlled arm movements. Start with shoulder abduction (lifting the arm sideways) and progress to external rotation (turning the arm outward) this is for axillary nerve glide, (extending your arm and fingers while tilting your head away from the affected side) this for median nerve glide and (Extend your arm out to the side at shoulder height-Rotate the arm so the palm faces upwards-Flex the wrist and fingers back gently-Tilt your head away from the extended arm to increase the stretch) this for radial nerve glide. Ensure movements are within a pain-free range. Stop if any discomfort occurs. Keep the floss band in place for 1-2 minutes while performing nerve glides. Remove the band after the exercise, allowing the skin to recover from compression.

Nerve Glide exercises

Procedures of Shoulder flossing application adding to Procedures of Nerve glide application.

Shoulder flossing with Nerve Glide

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale with post mastectomy axillary web syndrome
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy ,Cairo University

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant professor

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 17, 2025

Study Start

August 10, 2025

Primary Completion

December 1, 2025

Study Completion

December 5, 2025

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations