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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuan Yang Cheng, MD,PhD; Phone Number: 3500 +8864-2359-2525; Email: yycheng@vghtc.gov.tw
• Study Contact Backup: Name: Yu Chun Lee, MD, MHA; Phone Number: 3507 +8864-2359-2525; Email: lyczoj@vghtc.gov.tw

Study Locations

• Taiwan
  • Republic Of China(R.O.C)
    • Taichung, Republic Of China(R.O.C), Taiwan, 40705
      • Recruiting
      • Taichung Veterans General Hospital
      • Contact: Yuan Yang Cheng, MD, PhD; Phone Number: 3500 +886423592525; Email: yycheng@vghtc.gov.tw
      • Contact: Yu Chun Lee, MD, MHA; Phone Number: 3507 +886423592525; Email: lyczoj@vghtc.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 13, 2021
• Primary Completion (ANTICIPATED): August 31, 2022
• Study Completion (ANTICIPATED): August 31, 2024

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 (ACTUAL): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Lymphatic Diseases; Disease; Syndrome; Lymphedema; Shock
• 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