Axillary Web SyndromeNCT06269523
Effects of Rehabilitation and Kinesio Taping to Prevent Axillary Web Syndrome After Breast Cancer Surgery
A study testing Kinesio taping, Lymphatic drainage and Lymphatic drainage in people with Axillary Web Syndrome, run by University of Palermo at 1 site in Italy.
Trial summary
Axillary web syndrome (AWS) is a complication associated with breast cancer surgery, characterized by pain, functional limitation of the shoulder and decreased quality of life. There are several physical treatment options to reduce pain and improve the functionality of the upper limb in women with AWS. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Axillary Web Syndrome
- What is being tested?
- Kinesio taping, Lymphatic drainage and Lymphatic drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jul 2021to 31 Jan 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women between the ages of 45 and 65 years with diagnosis of breast cancer underwent to quadrantectomy and axillary lymphadenectomy.
Who cannot join
- metastatic disease, infections, past TVP, embolia.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
Palermo, 90127
About this study
Axillary web syndrome (AWS) is a complication associated with breast cancer surgery, characterized by pain, functional limitation of the shoulder and decreased quality of life. There are several physical treatment options to reduce pain and improve the functionality of the upper limb in women with AWS. This study evaluates the effectiveness of an early rehabilitation approach to prevent axillary web syndrome consisting in functional and proprioceptive re-education, manual lymphatic drainage and kinesio taping after breast cancer surgery.
Read the detailed description
Axillary web syndrome (AWS), is a complication associated with breast cancer surgery, characterized by pain, functional limitation of the shoulder and decreased quality of life. The pain is localized in the axillary area and along the arm, with the limitation of the glenohumeral joint (GO) and the presence of one or more "cords" of tissue visible or palpable with the abduction of the GO, at the level of the axilla , which can extend medially up to the wrist. Incidence, etiopathogenesis and ideal treatment of this condition are not yet clear.
The literature provides several physical treatment options for AWS. Physical therapy is effective in reducing pain and improving the functionality of the upper limb. Manual lymphatic drainage is indicated in forms of lymphedema due to axillary lymphadenectomy. The commonly used rehabilitation treatment consists of functional re-education of the shoulder, neuromotor and proprioceptive re-education of the upper limb, lymphatic drainage. Kinesio taping is rarely used and not in association with rehabilitation. This study evaluates the effectiveness of an early rehabilitation approach consisting of functional and proprioceptive re-education, manual lymphatic drainage and kinesio taping after quadrantectomy and lymphadenectoma surgery for breast cancer in the prevention of axillary web syndrome.
At the U.O.C. of Functional Recovery and Rehabilitation Department of the Paolo Giaccone University Hospital in Palermo, have been enrolled 18 women between the ages of 45 and 65 years old with a diagnosis of breast cancer, underwent to quadrantectomy and axillary lymphadenectomy.
Patients have been randomly divided into two groups: treatment group, in which kinesio taping has been applied, associated with a rehabilitation protocol lasting 18 sessions of functional and proprioceptive re-education and manual lymphatic drainage; control group, subjected to 18 sessions of functional and proprioceptive re-education, manual lymphatic drainage.
Patients have been evaluated: one week after surgery (T0), at the end of the 18 sessions (T1) and 3 months after surgery (T2).
The investigators evaluated: joint excursion shoulder's degree by a goniometer; the pain, using NRS scale; muscular strength of the upper limbs using a dynamometer (PINCH GAUGE); upper limbs circumference (cyrtometry) by a meter; and the functional capacity of the shoulder, using the Constant Murley scale.
- Conditions
- Axillary Web Syndrome
- Being tested
- Kinesio taping, Lymphatic drainage, Lymphatic drainage
- Keywords
- Axillary Web Syndrome, Kinesio taping, Lymphatic drainage, Breast cancer surgery, Proprioceptive re-education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio taping, Lymphatic drainageOther
Kinesio tape, is an elastic cotton strip with an acrylic adhesive that is purported to ease pain and disability from athletic injuries and a variety of other physical disorders. The application of Kinesio Tex Tape facilitates the opening of microvalves due to a dynamic pressure variation due to alteration in skin density. This decompression activates lymphatics in the dermis and improves lymphatic flow. The end result is a tissue inflammation and swelling reduction.It has been applied at the end over every session after lymphatic dreinage (see below).
Lymphatic drainageOther
Lymphatic drainage is a type of manual manipulation of the skin based on the hypothesis that it will encourage the natural drainage of the lymph, which carries waste products away from the tissues back toward the heart. The lymph system depends on intrinsic contractions of the smooth muscle cells in the walls of lymph vessels (peristalsis) and the movement of skeletal muscles to propel lymph through the vessels to lymph nodes and then to the lymph ducts, which return lymph to the cardiovascular system. Manual lymph drainage uses a specific amount of pressure and rhythmic circular movements to stimulate lymph flow.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | 18 sessions of functional and proprioceptive re-education, manual lymphatic drainage associated with kinesio taping. Receives: Other: Kinesio taping, Lymphatic drainage |
| Control group | Active comparator | 18 sessions of functional and proprioceptive re-education and manual lymphatic drainage. Receives: Other: Lymphatic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS Scale
NRS scale is an 11-point unidimensional scale that evaluates the intensity of pain in adults.The scale is composed of a horizontal line, with an interval ranging from 0 to 10, corresponding respectively to "no pain" and "worst pain imaginable".
Measured: one week after surgery(T0)- 5 weeks after surgery(T1)-12 weeks after surgery (t2)
Joint excursion shoulder
Range of motion of the shoulder taken with the use of a goniometer
Measured: one week after surgery(T0)-5 weeks after surgery(T1)- 12 weeks after surgery (t2)
Muscular strength of the upper limbs
Distal strength can be semiquantitatively measured with a dynamometer. Dynamometry is a more precise measurement of the force that a muscle can exert and can allow for differences in strength to be recorded over time.
Measured: one week after surgery(T0)- 5 weeks after surgery(T1) -12 weeks after surgery (t2)
Secondary outcomes (2)
Constant Murley Score
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).The higher the score, the higher the quality of the function.
Measured: one week after surgery(T0)- 5 weeks after surgery(T1)-12 weeks after surgery(t2)
upper limbs circumferenze (cyrtometry)
measurement of the circumference of the upper limb in some points(metacarpophalangeal joint, wrist, elbow, -14 cm from the lateral epicondyle of the elbow, -7 cm from the lateral epicondyle of the elbow), elbow (+7 cm from the lateral epicondyle, +14 cm from the lateral epicondyle) with a measuring tape in centimeters.
Measured: one week after surgery(T0)- 5 weeks after surgery(T1)- 12 weeks after surgery (t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start21 Jul 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.ssa Giulia Letizia Mauro, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269523
- Sponsor's protocol ID
- MFR032024
- Status last verified
- Nov 2023
- First submitted
- 1 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Moskovitz AH, Anderson BO, Yeung RS, Byrd DR, Lawton TJ, Moe RE. Axillary web syndrome after axillary dissection. Am J Surg. 2001 May;181(5):434-9. doi: 10.1016/s0002-9610(01)00602-x.
PubMed 11448437Agostini F, Attanasi C, Bernetti A, Mangone M, Paoloni M, Del Monte E, Mammucari M, Maggiori E, Russo D, Marzo RD, Migliore A, Paolucci T. Web Axillary Pain Syndrome-Literature Evidence and Novel Rehabilitative Suggestions: A Narrative Review. Int J Environ Res Public Health. 2021 Oct 2;18(19):10383. doi: 10.3390/ijerph181910383.
PubMed 34639683Dinas K, Kalder M, Zepiridis L, Mavromatidis G, Pratilas G. Axillary web syndrome: Incidence, pathogenesis, and management. Curr Probl Cancer. 2019 Dec;43(6):100470. doi: 10.1016/j.currproblcancer.2019.02.002. Epub 2019 Mar 15.
PubMed 30898366Ezzo J, Manheimer E, McNeely ML, Howell DM, Weiss R, Johansson KI, Bao T, Bily L, Tuppo CM, Williams AF, Karadibak D. Manual lymphatic drainage for lymphedema following breast cancer treatment. Cochrane Database Syst Rev. 2015 May 21;2015(5):CD003475. doi: 10.1002/14651858.CD003475.pub2.
PubMed 25994425Kasawara KT, Mapa JMR, Ferreira V, Added MAN, Shiwa SR, Carvas N Jr, Batista PA. Effects of Kinesio Taping on breast cancer-related lymphedema: A meta-analysis in clinical trials. Physiother Theory Pract. 2018 May;34(5):337-345. doi: 10.1080/09593985.2017.1419522. Epub 2018 Jan 8.
PubMed 29308967
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rehabilitation and Kinesio Taping to Prevent Axillary Web Syndrome After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT06269523
- Acronym / sponsor ID
- MFR032024
- Conditions
- Axillary Web Syndrome
- Keywords
- Axillary Web Syndrome, Kinesio taping, Lymphatic drainage, Breast cancer surgery, Proprioceptive re-education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 21 Feb 2024 (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 a complication associated with breast cancer surgery, characterized by pain, functional limitation of the shoulder and decreased quality of life. There are several physical treatment options to reduce pain and improve the functionality of the upper limb in women with AWS. This study evaluates the effectiveness of an early rehabilitation approach to prevent axillary web syndrome consisting in functional and proprioceptive re-education, manual lymphatic drainage and kinesio taping after breast cancer surgery.
Detailed description
Axillary web syndrome (AWS), is a complication associated with breast cancer surgery, characterized by pain, functional limitation of the shoulder and decreased quality of life. The pain is localized in the axillary area and along the arm, with the limitation of the glenohumeral joint (GO) and the presence of one or more "cords" of tissue visible or palpable with the abduction of the GO, at the level of the axilla , which can extend medially up to the wrist. Incidence, etiopathogenesis and ideal treatment of this condition are not yet clear.
The literature provides several physical treatment options for AWS. Physical therapy is effective in reducing pain and improving the functionality of the upper limb. Manual lymphatic drainage is indicated in forms of lymphedema due to axillary lymphadenectomy. The commonly used rehabilitation treatment consists of functional re-education of the shoulder, neuromotor and proprioceptive re-education of the upper limb, lymphatic drainage. Kinesio taping is rarely used and not in association with rehabilitation. This study evaluates the effectiveness of an early rehabilitation approach consisting of functional and proprioceptive re-education, manual lymphatic drainage and kinesio taping after quadrantectomy and lymphadenectoma surgery for breast cancer in the prevention of axillary web syndrome.
At the U.O.C. of Functional Recovery and Rehabilitation Department of the Paolo Giaccone University Hospital in Palermo, have been enrolled 18 women between the ages of 45 and 65 years old with a diagnosis of breast cancer, underwent to quadrantectomy and axillary lymphadenectomy.
Patients have been randomly divided into two groups: treatment group, in which kinesio taping has been applied, associated with a rehabilitation protocol lasting 18 sessions of functional and proprioceptive re-education and manual lymphatic drainage; control group, subjected to 18 sessions of functional and proprioceptive re-education, manual lymphatic drainage.
Patients have been evaluated: one week after surgery (T0), at the end of the 18 sessions (T1) and 3 months after surgery (T2).
The investigators evaluated: joint excursion shoulder's degree by a goniometer; the pain, using NRS scale; muscular strength of the upper limbs using a dynamometer (PINCH GAUGE); upper limbs circumference (cyrtometry) by a meter; and the functional capacity of the shoulder, using the Constant Murley scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Other: Kinesio taping, Lymphatic drainage18 sessions of functional and proprioceptive re-education, manual lymphatic drainage associated with kinesio taping. |
| Control group | Active comparator | Other: Lymphatic drainage18 sessions of functional and proprioceptive re-education and manual lymphatic drainage. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women between the ages of 45 and 65 years with diagnosis of breast cancer underwent to quadrantectomy and axillary lymphadenectomy.
Key exclusion criteria (1 listed)
- metastatic disease, infections, past TVP, embolia.
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 |
|---|---|---|
| Kinesio taping, Lymphatic drainageKinesio tape, is an elastic cotton strip with an acrylic adhesive that is purported to ease pain and disability from athletic injuries and a variety of other physical disorders. The application of Kinesio Tex Tape facilitates the opening of microvalves due to a dynamic pressure variation due to alteration in skin density. This decompression activates lymphatics in the dermis and improves lymphatic flow. The end result is a tissue inflammation and swelling reduction.It has been applied at the end over every session after lymphatic dreinage (see below). | Other | Treatment group |
| Lymphatic drainageLymphatic drainage is a type of manual manipulation of the skin based on the hypothesis that it will encourage the natural drainage of the lymph, which carries waste products away from the tissues back toward the heart. The lymph system depends on intrinsic contractions of the smooth muscle cells in the walls of lymph vessels (peristalsis) and the movement of skeletal muscles to propel lymph through the vessels to lymph nodes and then to the lymph ducts, which return lymph to the cardiovascular system. Manual lymph drainage uses a specific amount of pressure and rhythmic circular movements to stimulate lymph flow. | Other | Control group |
Primary outcome
NRS Scale
Time frame: one week after surgery(T0)- 5 weeks after surgery(T1)-12 weeks after surgery (t2)
NRS scale is an 11-point unidimensional scale that evaluates the intensity of pain in adults.The scale is composed of a horizontal line, with an interval ranging from 0 to 10, corresponding respectively to "no pain" and "worst pain imaginable".
Joint excursion shoulder
Time frame: one week after surgery(T0)-5 weeks after surgery(T1)- 12 weeks after surgery (t2)
Range of motion of the shoulder taken with the use of a goniometer
Muscular strength of the upper limbs
Time frame: one week after surgery(T0)- 5 weeks after surgery(T1) -12 weeks after surgery (t2)
Distal strength can be semiquantitatively measured with a dynamometer. Dynamometry is a more precise measurement of the force that a muscle can exert and can allow for differences in strength to be recorded over time.
2 secondary outcomes
Constant Murley Score
Time frame: one week after surgery(T0)- 5 weeks after surgery(T1)-12 weeks after surgery(t2)
upper limbs circumferenze (cyrtometry)
Time frame: one week after surgery(T0)- 5 weeks after surgery(T1)- 12 weeks after surgery (t2)
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 21 Feb 2024.
- Background: PubMed 11448437Moskovitz AH, Anderson BO, Yeung RS, Byrd DR, Lawton TJ, Moe RE. Axillary web syndrome after axillary dissection. Am J Surg. 2001 May;181(5):434-9. doi: 10.1016/s0002-9610(01)00602-x.
- Background: PubMed 34639683Agostini F, Attanasi C, Bernetti A, Mangone M, Paoloni M, Del Monte E, Mammucari M, Maggiori E, Russo D, Marzo RD, Migliore A, Paolucci T. Web Axillary Pain Syndrome-Literature Evidence and Novel Rehabilitative Suggestions: A Narrative Review. Int J Environ Res Public Health. 2021 Oct 2;18(19):10383. doi: 10.3390/ijerph181910383.
- Background: PubMed 30898366Dinas K, Kalder M, Zepiridis L, Mavromatidis G, Pratilas G. Axillary web syndrome: Incidence, pathogenesis, and management. Curr Probl Cancer. 2019 Dec;43(6):100470. doi: 10.1016/j.currproblcancer.2019.02.002. Epub 2019 Mar 15.
- Background: PubMed 25994425Ezzo J, Manheimer E, McNeely ML, Howell DM, Weiss R, Johansson KI, Bao T, Bily L, Tuppo CM, Williams AF, Karadibak D. Manual lymphatic drainage for lymphedema following breast cancer treatment. Cochrane Database Syst Rev. 2015 May 21;2015(5):CD003475. doi: 10.1002/14651858.CD003475.pub2.
- Background: PubMed 29308967Kasawara KT, Mapa JMR, Ferreira V, Added MAN, Shiwa SR, Carvas N Jr, Batista PA. Effects of Kinesio Taping on breast cancer-related lymphedema: A meta-analysis in clinical trials. Physiother Theory Pract. 2018 May;34(5):337-345. doi: 10.1080/09593985.2017.1419522. Epub 2018 Jan 8.
- Individual participant dataSharing planned: Yes
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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 Kinesio taping, Lymphatic drainage and Lymphatic drainage in people with Axillary Web Syndrome, run by University of Palermo at 1 site in Italy.
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 1 inclusion and 1 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 21 Feb 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 Italy. 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?
NRS Scale (time frame: one week after surgery(T0)- 5 weeks after surgery(T1)-12 weeks after surgery (t2)). The study lists 3 primary outcomes in all. 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 NCT06269523, which also lists 5 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 21 Feb 2024.