Clinical Outcome of Extracorporeal Shock Wave Therapy in Patient With Axillary Web Syndrome

Clinical Outcome of Extracorporeal Shock Wave Therapy in Patient With Axillary Web Syndrome-A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lymphedema; Axillary Web Syndrome; Extracorporeal Shock Wave Therapy
• Intervention / Treatment: Device: Low energy ESWT

Detailed Description

Although the anticipated enrollment was 30 participants, the study was completed with 20 participants due to early attainment of statistical significance and recruitment feasibility.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung City
    • Taichung, Taichung City, Taiwan, 407219
      • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Ongoing metastasis or recurrence of the breast cancer
2. Other cancer history
3. Lymphatic transplantation or reconstruction
4. Wound, infection or trauma over affected arm
5. Coagulopathy or poor circulation
6. Pregnancy
7. Oral anticoagulant using

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESWT; Receive low energy extracorporeal shock wave therapy	Device: Low energy ESWT; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	Muscle strength of upper limb measured by ergometer	2 months
Upper limb functional score	quick Disabilities of the Arm, Shoulder and Hand Score(qDASH) (0-100 points, higher score indicated higher level of upper limb impairment)	2 months

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Study Chair: Yu Lin Tsai, MD, Department of Physical Medicine and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Lymphatic Diseases; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: CF21163B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No