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

NCT ID: NCT05082597

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-13
• Study Completion Date: 2025-03-31

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.

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.

Conditions

Axillary Web Syndrome; Breast Cancer; Lymphedema; Extracorporeal Shock Wave Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ESWT

Receive low energy extracorporeal shock wave therapy

Group Type: EXPERIMENTAL

Low energy ESWT

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Taichung Veterans General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu Lin Tsai, MD

Role: STUDY_CHAIR

Department of Physical Medicine and Rehabilitation

Locations

Taichung Veterans General Hospital

Taichung, Taichung City, Taiwan

Countries

Taiwan

Other Identifiers

CF21163B

Identifier Type: -

Identifier Source: org_study_id