Axillary Web SyndromeNCT05082597
Clinical Outcome of Extracorporeal Shock Wave Therapy in Patient With Axillary Web Syndrome
A study testing Low energy ESWT in people with Axillary Web Syndrome and Breast Cancer, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Axillary Web Syndrome, Breast Cancer, Lymphedema
- What is being tested?
- Low energy ESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Oct 2021to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taichung Veterans General Hospital
Taichung, Taichung City, 407219
About this study
Official title: Clinical Outcome of Extracorporeal Shock Wave Therapy in Patient With Axillary Web Syndrome-A Pilot Study
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.
Read the 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.
- Being tested
- Low energy ESWT
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low energy ESWTDevice
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
| Study group | Role | What they receive |
|---|---|---|
| ESWT | Experimental | Receive low energy extracorporeal shock wave therapy Receives: Device: Low energy ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder range of motion
Flexion, extension, external rotation, internal rotation, abduction over upper limbs
Measured: 2 months
Pain score
Visual Analogue Scale (0-10 points, higher score represented higher degree of pain)
Measured: 2 months
Secondary outcomes (2)
Muscle strength
Muscle strength of upper limb measured by ergometer
Measured: 2 months
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)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start13 Oct 2021
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axillary Web SyndromeStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Lin Tsai, MD, Study chair, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082597
- Sponsor's protocol ID
- CF21163B
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2021
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Extracorporeal Shock Wave Therapy in Patient With Axillary Web Syndrome-A Pilot Study
- ClinicalTrials.gov ID
- NCT05082597
- Acronym / sponsor ID
- CF21163B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESWT | Experimental | Device: Low energy ESWTReceive low energy extracorporeal shock wave therapy |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low energy ESWTTherapeutic 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 | Device | ESWT |
Primary outcome
Shoulder range of motion
Time frame: 2 months
Flexion, extension, external rotation, internal rotation, abduction over upper limbs
Pain score
Time frame: 2 months
Visual Analogue Scale (0-10 points, higher score represented higher degree of pain)
2 secondary outcomes
Muscle strength
Time frame: 2 months
Upper limb functional score
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Axillary Web Syndrome
RecruitingObservational study
Axillary Web Syndrome After Breast Cancer Surgery: Incidence, Risk Factors, and Functional Outcomes
Axillary Web Syndrome, Breast Cancer
RecruitingObservational study
Deep Learning for Musculoskeletal Complications in Breast Cancer
Postmastectomy Lymphedema Syndrome, Breast Cancer Surgery Pain
Not yet recruiting
Effects of Muscle Energy Techniques With and Without Manual Axial Distraction in Post-Mastectomy Patients With Axillary Web Syndrome
Axillary Web Syndrome, Post-mastectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Lin Tsai, MD study chair
Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low energy ESWT in people with Axillary Web Syndrome and Breast Cancer, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder range of motion (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.