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

Not Applicable

Recruiting

• Conditions: Axillary Web Syndrome; Lymphedema; Extracorporeal Shock Wave Therapy; Breast Cancer
• Interventions: Device: Low energy ESWT

• Registration Number: NCT05082597
• Lead Sponsor: Taichung Veterans General Hospital

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

Not available

Study Timeline

• Study First Submitted: 2021-09-24
• Study Start: 2021-10-13
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-19
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-18
• Primary Completion: 2022-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ESWT	Low energy ESWT	Receive low energy extracorporeal shock wave therapy

Primary Outcome Measures

Name	Time	Method
Pain score	2 months	Visual Analogue Scale (0-10 points, higher score represented higher degree of pain)
Shoulder range of motion	2 months	Flexion, extension, external rotation, internal rotation, abduction over upper limbs

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Republic Of China(R.O.C), Taiwan