Axillary Web SyndromeCBawsNCT04338334
Effectiveness of Cohesive Bandage on Axillary Web Syndrome After
A study testing Manual drainage & arm therapeutic exercise and Cohesive bandaging & arm therapeutic exercise in people with Axillary Web Syndrome, run by University of Alcala at 1 site in Spain.
Trial summary
Objective: To determine the effectiveness of cohesive bandage on the axillary web syndrome in improving pain, reducing swelling and increasing mobility and functionality 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?
- Manual drainage & arm therapeutic exercise and Cohesive bandaging & arm therapeutic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2019to Dec 2024
- 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 upper limb of the operated side;
- Consent to participate in the study;
- No contraindications.
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.
Beatriz Navarro-Brazález, PhD contact
Spain1 site, 1 recruiting
- Recruiting
María Torres-Lacomba
Alcalá de Henares, Madrid, 28005
María Torres-Lacomba, PhD, 678900061, maria.torres@uah.es
Beatriz Navarro-Brazález, PhD, b.navarrobrazalez@gmail.com
About this study
Official title: Effectiveness of Cohesive Bandage on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial
Objective: To determine the effectiveness of cohesive bandage on the axillary web syndrome in improving pain, reducing swelling and increasing mobility and functionality of the shoulder. Design: randomized single-blinded controlled trial. Follow-up: five physical therapy assessments: pre-intervention; post-intervention, 3 and 6 months post-intervention post-intervention. Participants: 90 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: Control 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 arm therapeutic exercises; Intervention group: progressive active arm therapeutic exercises with cohesive bandage.
- Conditions
- Axillary Web Syndrome
- Being tested
- Manual drainage & arm therapeutic exercise, Cohesive bandaging & arm therapeutic exercise
- Keywords
- Cohesive bandage, Physical Therapy, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual drainage & arm therapeutic exerciseOther
See arm/group descriptions.
Cohesive bandaging & arm therapeutic exerciseOther
See arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | Active comparator | Control group includes physical therapy protocol 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 arm therapeutic exercises. Receives: Other: Manual drainage & arm therapeutic exercise |
| COHESIVE BANDAGE GROUP | Experimental | Cohesive bandage is a self-adherent lightweight bandage, made of a porous nonwoven polyester material. A single self-adherent inelastic bandage will be directly applied at full stretch on cleaned and dried skin (10cm 3M CobanTM Minnesota Mining and Manufacturing Co, United States) in a spiral method around the limb, starting at the hand and a layer overlap of 50%, so that the greatest compression was located at the distal points, gradually decreasing toward the proximal shoulder part. Cohesive latex-free bandages will be available for those allergic women. Women will do progressive active arm therapeutic exercises with bandaging. Receives: Other: Cohesive bandaging & arm therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Subjective pain
Visual Analogue Scale (0-10 cm)
Measured: 4 assessments to evaluate change from baseline: at baseline, after the intervention period (6 weeks from baseline), 3 and 6 months after the intervention.
Secondary outcomes (3)
Change from baseline in Range of shoulder motion
Inclinometer (measured in grades)
Measured: 4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.
Change from baseline in perceived shoulder disability
Oxford Shoulder Score. The OSS is a unidimensional score comprising 12 questions about pain and disability involving activities of daily routine. Thus, each of the 12 questions is scored from 0 to 4, with 4 representing best outcome/least symptoms. Scores from each question are summed so the overall score run from 0 to 48 with 48 being the best outcome; so that the lower scores indicate more pain and disability. The OSS Spanish version is applicable, reliable, valid, and responsive to assess shoulder disability in Spanish women after breast cancer treatment
Measured: 4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.
Change from baseline in QoL
FACTB+4. Health-related quality of life (HRQoL): HRQoL was measured with the Functional Assessment of Cancer Therapy-Breast (FACT-B) Spanish version 4. FACT-Bv4 is a 40-item questionnaire designed to measure multidimensional HRQoL in women with breast cancer. The 40 items cover four generic scales of well-being (Physical, Emotional, Social, and Functional) and two side-specific subscales: Breast Cancer (9 items) and Arm (4 items). The Arm-specific subscale assesses arm morbidity: 1) pain, 2) poor range of arm movements, 3) numbness, and 4) stiffness. The Breast Cancer subscale plus the arm subscale range from 0 to 56 points. The Trial Outcome Index (TOI) is the sum of Physical and Functional wellbeing plus Breast Cancer Subscale (range 0-92 points). The FACT-B total score can range from 0 to 144, with a higher score indicating better HRQoL.
Measured: 4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start10 Jan 2019
- Primary completion10 Sep 2024 (estimated)
- Study completionDec 2024 (estimated)
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.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Torres Lacomba, University of Alcala
- Investigators
- María Torres-Lacomba, PhD, Principal investigator, University of Alcalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338334
- Sponsor's protocol ID
- OE20/2020
- Acronym
- CBaws
- Status last verified
- Jan 2024
- First submitted
- 4 Apr 2020
- Last updated
- 19 Jan 2024
- 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 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cohesive Bandage on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04338334
- Acronym / sponsor ID
- CBaws / OE20/2020
- Conditions
- Axillary Web Syndrome
- Keywords
- Cohesive bandage, Physical Therapy, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Apr 2020 (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.
Objective: To determine the effectiveness of cohesive bandage on the axillary web syndrome in improving pain, reducing swelling and increasing mobility and functionality of the shoulder. Design: randomized single-blinded controlled trial. Follow-up: five physical therapy assessments: pre-intervention; post-intervention, 3 and 6 months post-intervention post-intervention. Participants: 90 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: Control 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 arm therapeutic exercises; Intervention group: progressive active arm therapeutic exercises with cohesive bandage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | Active comparator | Other: Manual drainage & arm therapeutic exerciseControl group includes physical therapy protocol 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 arm therapeutic exercises. |
| COHESIVE BANDAGE GROUP | Experimental | Other: Cohesive bandaging & arm therapeutic exerciseCohesive bandage is a self-adherent lightweight bandage, made of a porous nonwoven polyester material. A single self-adherent inelastic bandage will be directly applied at full stretch on cleaned and dried skin (10cm 3M CobanTM Minnesota Mining and Manufacturing Co, United States) in a spiral method around the limb, starting at the hand and a layer overlap of 50%, so that the greatest compression was located at the distal points, gradually decreasing toward the proximal shoulder part. Cohesive latex-free bandages will be available for those allergic women. Women will do progressive active arm therapeutic exercises with bandaging. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral breast cancer;
- Breast surgery with lymphadenectomy and / or sentinel lymph node biopsy;
- Axillary web syndrome in upper limb of the operated side;
- Consent to participate in the study;
- No contraindications.
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 |
|---|---|---|
| Manual drainage & arm therapeutic exerciseSee arm/group descriptions. | Other | CONTROL GROUP |
| Cohesive bandaging & arm therapeutic exerciseSee arm/group descriptions. | Other | COHESIVE BANDAGE GROUP |
Primary outcome
Change from baseline in Subjective pain
Time frame: 4 assessments to evaluate change from baseline: at baseline, after the intervention period (6 weeks from baseline), 3 and 6 months after the intervention.
Visual Analogue Scale (0-10 cm)
3 secondary outcomes
Change from baseline in Range of shoulder motion
Time frame: 4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.
Change from baseline in perceived shoulder disability
Time frame: 4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.
Change from baseline in QoL
Time frame: 4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Axillary Web Syndrome
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Postmastectomy Lymphedema Syndrome, Breast Cancer Surgery Pain
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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.
Beatriz Navarro-Brazález, PhD contact
María Torres-Lacomba, PhD principal investigator
University of Alcalá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual drainage & arm therapeutic exercise and Cohesive bandaging & arm therapeutic exercise 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 5 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: status not confirmed, as of the sponsor's last update on 19 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Torres-Lacomba, PhD (+34678900061, maria.torres@uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Subjective pain (time frame: 4 assessments to evaluate change from baseline: at baseline, after the intervention period (6 weeks from baseline), 3 and 6 months after the intervention.). 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 19 Jan 2024.