Axillary Web Syndrome, Breast Cancer, Lymphedema, Extracorporeal Shock Wave Therapy
Conditions
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.
Interventions
DEVICELow 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
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder range of motion | 2 months | Flexion, extension, external rotation, internal rotation, abduction over upper limbs |
| Pain score | 2 months | Visual Analogue Scale (0-10 points, higher score represented higher degree of pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Taiwan
Outcome results
None listed