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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05082597
• Other study ID #: CF21163B
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2022
• Source: Taichung Veterans General Hospital
• Contact: Yuan Yang Cheng, MD,PhD
• Phone: +8864-2359-2525
• Email: yycheng[@]vghtc.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Axillary Web Syndrome
• Breast Cancer
• Lymphedema
• Shock
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung	Republic Of China(R.O.C)

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder range of motion	Flexion, extension, external rotation, internal rotation, abduction over upper limbs	2 months
Primary	Pain score	Visual Analogue Scale (0-10 points, higher score represented higher degree of pain)	2 months
Secondary	Muscle strength	Muscle strength of upper limb measured by ergometer	2 months
Secondary	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