NCT05082597

Brief Summary

Axillary web syndrome(AWS) is common complication of breast cancer surgery. Overall, AWS affects more than a half of the patient receiving axillary lymph node dissection. The symptoms of AWS include pain, limited function and range of motion. Geater risk of secondary lymphedema was found if the patient developed AWS during the first postoperative year. ESWT was used for treating myofascial pain for decades. Low energy ESWT combined with complex decongestive therapy had a benefit on shoulder joint ROM and skin thickness improvement in patients with BCRL in recently studies. Investigators wonder if ESWT can also be applied to patients with axillary web syndrome for increasing ROM and relieving pain. The aim of this study was to evaluate the therapeutic effects of low energy ESWT in patients with axillary web syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

October 13, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

3.5 years

First QC Date

September 24, 2021

Last Update Submit

September 2, 2025

Conditions

Axillary Web SyndromeBreast CancerLymphedemaExtracorporeal Shock Wave Therapy

Outcome Measures

Primary Outcomes (2)

  • Shoulder range of motion

    Flexion, extension, external rotation, internal rotation, abduction over upper limbs

    2 months

  • Pain score

    Visual Analogue Scale (0-10 points, higher score represented higher degree of pain)

    2 months

Secondary Outcomes (2)

  • Muscle strength

    2 months

  • Upper limb functional score

    2 months

Study Arms (1)

ESWT

EXPERIMENTAL

Receive low energy extracorporeal shock wave therapy

Device: Low energy ESWT

Interventions

Low energy ESWTDEVICE

Therapeutic sessions: 4(once a week, for 4 weeks) Total dosage: 2500 shoots over axillary cord lesion (1000 over most fibrotic area, 500 over upper arm, 500 over forearm, 500 over other area) Energy: 0.056-0.065mJ/mm2

ESWT

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Axillary web syndrome patient
  • Unilateral breast cancer and received related operation(mastectomy/ALND/SLND)
  • Completion of beast related chemotherapy or radiotherapy
  • Age with 20-65 years old

You may not qualify if:

  • Ongoing metastasis or recurrence of the breast cancer
  • Other cancer history
  • Lymphatic transplantation or reconstruction
  • Wound, infection or trauma over affected arm
  • Coagulopathy or poor circulation
  • Pregnancy
  • Oral anticoagulant using

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taichung City, 407219, Taiwan

Location

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Yu Lin Tsai, MD

    Department of Physical Medicine and Rehabilitation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2021

First Posted

October 19, 2021

Study Start

October 13, 2021

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)