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Clinical Trials/NCT05082597
NCT05082597CompletedNot Applicable

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

Taichung Veterans General Hospital2 sites in 1 country20 target enrollmentStarted: October 13, 2021Last updated:
Conditions

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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