Axillary Web SyndromePTawsNCT02224261
Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery
A study testing Physical Therapy protocol in people with Axillary Web Syndrome, run by University of Alcala at 1 site in Spain.
Trial summary
Objective: To determine the effectiveness of physical therapy on the axillary web syndrome in improving pain, reducing swelling and increasing mobility of the shoulder. Design: randomized single-blinded controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Axillary Web Syndrome
- What is being tested?
- Physical Therapy protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2016to 10 Dec 2019
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral breast cancer;
- Breast surgery with lymphadenectomy and / or sentinel lymph node biopsy;
- Axillary web syndrome in chest and / or upper limb of the operated side;
- VAS>3
- Consent to participate in the study;
- No contraindications for physical therapy (infection, metastasis);
Who cannot join
- Cognitive impairment;
- Visual impairment for reading;
- Lymphedema;
- Bilateral breast cancer;
- Systemic disease (metastases),
- Infection;
- Locoregional recurrence.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Physiotherapy in women´s health research group. University of Alcalà
Alcalà de Henares, Madrid, 28871
About this study
Official title: Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial
Objective: To determine the effectiveness of physical therapy on the axillary web syndrome in improving pain, reducing swelling and increasing mobility of the shoulder. Design: randomized single-blinded controlled trial. Follow-up: five physical therapy assessments: pre-intervention; post-intervention, 3 months post-intervention, 6 months post-intervention. Participants: Eighty consecutive women diagnosed with axillary web syndrome after undergoing unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two groups by EpiData 3.1 software. Interventions: Physical Therapy group: Physical Therapy composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises; Control group: standard progressive active and action-assisted arm exercises. 9 physical therapy sessions.
- Conditions
- Axillary Web Syndrome
- Being tested
- Physical Therapy protocol, Control
- Keywords
- Axillary web syndrome, cording, physical therapy, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy protocolOther
Also called PT-AWS
Physical therapy protocol includes manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises "stretching" cords, and patient education.
ControlOther
Also called CG
Control protocol includes standard progressive active and action-assisted arm exercises \& patient education.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy | Experimental | Physical therapy protocol includes manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises "stretching" cords and patient education. Receives: Other: Physical Therapy protocol |
| Control | Active comparator | Control protocol includes standard progressive active and action-assisted arm exercises \& patient education. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Subjective pain at one month (post-intervention); and 3 and 6 months post-intervention
Visual Analogue Scale
Measured: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
Secondary outcomes (1)
Change from baseline in Range of shoulder motion at one month (post-intervention); and 3 and 6 months post-intervention
Inclinometer
Measured: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study start10 Jan 2016
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Axillary Web SyndromeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Principe de Asturias
- Responsible party
- Principal investigator, Maria Torres Lacomba, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224261
- Sponsor's protocol ID
- 11/032
- Acronym
- PTaws
- Status last verified
- Sep 2023
- First submitted
- 20 Aug 2014
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Torres Lacomba M, Mayoral Del Moral O, Coperias Zazo JL, Yuste Sanchez MJ, Ferrandez JC, Zapico Goni A. Axillary web syndrome after axillary dissection in breast cancer: a prospective study. Breast Cancer Res Treat. 2009 Oct;117(3):625-30. doi: 10.1007/s10549-009-0371-8. Epub 2009 Mar 21.
PubMed 19306057Torres-Lacomba M, Prieto-Gomez V, Arranz-Martin B, Ferrandez JC, Yuste-Sanchez MJ, Navarro-Brazalez B, Romay-Barrero H. Manual Lymph Drainage With Progressive Arm Exercises for Axillary Web Syndrome After Breast Cancer Surgery: A Randomized Controlled Trial. Phys Ther. 2022 Mar 1;102(3):pzab314. doi: 10.1093/ptj/pzab314.
PubMed 35079831
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02224261
- Acronym / sponsor ID
- PTaws / 11/032
- Conditions
- Axillary Web Syndrome
- Keywords
- Axillary web syndrome, cording, physical therapy, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Collaborators
- Hospital Universitario Principe de Asturias
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 25 Aug 2014 (estimated)
- 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.
Objective: To determine the effectiveness of physical therapy on the axillary web syndrome in improving pain, reducing swelling and increasing mobility of the shoulder. Design: randomized single-blinded controlled trial. Follow-up: five physical therapy assessments: pre-intervention; post-intervention, 3 months post-intervention, 6 months post-intervention. Participants: Eighty consecutive women diagnosed with axillary web syndrome after undergoing unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two groups by EpiData 3.1 software. Interventions: Physical Therapy group: Physical Therapy composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises; Control group: standard progressive active and action-assisted arm exercises. 9 physical therapy sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy | Experimental | Other: Physical Therapy protocolPhysical therapy protocol includes manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises "stretching" cords and patient education. |
| Control | Active comparator | Other: ControlControl protocol includes standard progressive active and action-assisted arm exercises \& patient education. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral breast cancer;
- Breast surgery with lymphadenectomy and / or sentinel lymph node biopsy;
- Axillary web syndrome in chest and / or upper limb of the operated side;
- VAS>3
- Consent to participate in the study;
Key exclusion criteria (7 listed)
- Cognitive impairment;
- Visual impairment for reading;
- Lymphedema;
- Bilateral breast cancer;
- Systemic disease (metastases),
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 |
|---|---|---|
| Physical Therapy protocolAlso: PT-AWSPhysical therapy protocol includes manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises "stretching" cords, and patient education. | Other | Physical Therapy |
| ControlAlso: CGControl protocol includes standard progressive active and action-assisted arm exercises \& patient education. | Other | Control |
Primary outcome
Change from baseline in Subjective pain at one month (post-intervention); and 3 and 6 months post-intervention
Time frame: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
Visual Analogue Scale
1 secondary outcome
Change from baseline in Range of shoulder motion at one month (post-intervention); and 3 and 6 months post-intervention
Time frame: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
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 28 Sep 2023.
- Background: PubMed 19306057Torres Lacomba M, Mayoral Del Moral O, Coperias Zazo JL, Yuste Sanchez MJ, Ferrandez JC, Zapico Goni A. Axillary web syndrome after axillary dissection in breast cancer: a prospective study. Breast Cancer Res Treat. 2009 Oct;117(3):625-30. doi: 10.1007/s10549-009-0371-8. Epub 2009 Mar 21.
- Results publication: PubMed 35079831Torres-Lacomba M, Prieto-Gomez V, Arranz-Martin B, Ferrandez JC, Yuste-Sanchez MJ, Navarro-Brazalez B, Romay-Barrero H. Manual Lymph Drainage With Progressive Arm Exercises for Axillary Web Syndrome After Breast Cancer Surgery: A Randomized Controlled Trial. Phys Ther. 2022 Mar 1;102(3):pzab314. doi: 10.1093/ptj/pzab314.
Related trials for Axillary Web Syndrome
RecruitingObservational study
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Effects of Muscle Energy Techniques With and Without Manual Axial Distraction in Post-Mastectomy Patients With Axillary Web Syndrome
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy protocol in people with Axillary Web Syndrome, run by University of Alcala at 1 site in Spain.
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 6 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 28 Sep 2023. 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 Spain. 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?
Change from baseline in Subjective pain at one month (post-intervention); and 3 and 6 months post-intervention (time frame: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02224261, which also lists 2 linked publications.
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 28 Sep 2023.