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

Study Overview
=================
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.

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

Conditions
-----------------
Axillary Web Syndrome, Breast Cancer, Lymphedema, Extracorporeal Shock Wave Therapy

Intervention / Treatment
-----------------
* Device: Low energy ESWT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESWT<br>Receive low energy extracorporeal shock wave therapy | Device: Low energy ESWT<br>* 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<br>|

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 |