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Completed

NCT Number: NCT05082597

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

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.

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Key information

Conditions

Axillary Web Syndrome Breast Cancer Breast Diseases Breast Neoplasms Extracorporeal Shock Wave Therapy Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital

Taichung, Taichung City, 407219, Taiwan

About this study

Although the anticipated enrollment was 30 participants, the study was completed with 20 participants due to early attainment of statistical significance and recruitment feasibility.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low energy ESWT

Device

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 outcomes

  1. Shoulder range of motion

    Time frame: 2 months

    Flexion, extension, external rotation, internal rotation, abduction over upper limbs

  2. Pain score

    Time frame: 2 months

    Visual Analogue Scale (0-10 points, higher score represented higher degree of pain)

Secondary outcomes

  1. Muscle strength

    Time frame: 2 months

    Muscle strength of upper limb measured by ergometer

  2. Upper limb functional score

    Time frame: 2 months

    quick Disabilities of the Arm, Shoulder and Hand Score(qDASH) (0-100 points, higher score indicated higher level of upper limb impairment)

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 19, 2021
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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