Clinical Outcome of Extracorporeal Shock Wave Therapy in Patient With Axillary Web Syndrome
Primary Purpose
Axillary Web Syndrome, Breast Cancer, Lymphedema
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Low energy ESWT
Sponsored by
About this trial
This is an interventional treatment trial for Axillary Web Syndrome
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
Sites / Locations
- Taichung Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ESWT
Arm Description
Receive low energy extracorporeal shock wave therapy
Outcomes
Primary Outcome Measures
Shoulder range of motion
Flexion, extension, external rotation, internal rotation, abduction over upper limbs
Pain score
Visual Analogue Scale (0-10 points, higher score represented higher degree of pain)
Secondary Outcome Measures
Muscle strength
Muscle strength of upper limb measured by ergometer
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)
Full Information
NCT ID
NCT05082597
First Posted
September 24, 2021
Last Updated
July 14, 2022
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05082597
Brief Title
Clinical Outcome of Extracorporeal Shock Wave Therapy in Patient With Axillary Web Syndrome
Official Title
Clinical Outcome of Extracorporeal Shock Wave Therapy in Patient With Axillary Web Syndrome-A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axillary Web Syndrome, Breast Cancer, Lymphedema, Extracorporeal Shock Wave Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESWT
Arm Type
Experimental
Arm Description
Receive low energy extracorporeal shock wave therapy
Intervention Type
Device
Intervention Name(s)
Low energy ESWT
Intervention Description
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
Primary Outcome Measure Information:
Title
Shoulder range of motion
Description
Flexion, extension, external rotation, internal rotation, abduction over upper limbs
Time Frame
2 months
Title
Pain score
Description
Visual Analogue Scale (0-10 points, higher score represented higher degree of pain)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Muscle strength
Description
Muscle strength of upper limb measured by ergometer
Time Frame
2 months
Title
Upper limb functional score
Description
quick Disabilities of the Arm, Shoulder and Hand Score(qDASH) (0-100 points, higher score indicated higher level of upper limb impairment)
Time Frame
2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Yang Cheng, MD,PhD
Phone
+8864-2359-2525
Ext
3500
Email
yycheng@vghtc.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Chun Lee, MD, MHA
Phone
+8864-2359-2525
Ext
3507
Email
lyczoj@vghtc.gov.tw
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
State/Province
Republic Of China(R.O.C)
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Yang Cheng, MD, PhD
Phone
+886423592525
Ext
3500
Email
yycheng@vghtc.gov.tw
First Name & Middle Initial & Last Name & Degree
Yu Chun Lee, MD, MHA
Phone
+886423592525
Ext
3507
Email
lyczoj@vghtc.gov.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Outcome of Extracorporeal Shock Wave Therapy in Patient With Axillary Web Syndrome
We'll reach out to this number within 24 hrs