Clinical Outcome of Extracorporeal Shock Wave Therapy in Patient With Axillary Web Syndrome-A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Pain score
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.
Detailed Description
Although the anticipated enrollment was 30 participants, the study was completed with 20 participants due to early attainment of statistical significance and recruitment feasibility.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •Oral anticoagulant using
Outcomes
Primary Outcomes
Pain score
Time Frame: 2 months
Visual Analogue Scale (0-10 points, higher score represented higher degree of pain)
Shoulder range of motion
Time Frame: 2 months
Flexion, extension, external rotation, internal rotation, abduction over upper limbs
Secondary Outcomes
- Muscle strength(2 months)
- Upper limb functional score(2 months)