LymphedemaCB-ULLNCT03250364
Compression Bandages in Upper Limb Lymphedema
A study testing Multilayer bandage, Double compression bandage and Cohesive bandage in people with Lymphedema, run by University of Alcala at 2 sites in Spain.
Trial summary
Despite different types of bandages are using in the lymphedema treatment, numerous of them have not been directly compared. The aim of this study is to compare the efficacy of five different kinds of bandages on limb volume and lymphedema-related symptoms. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- Multilayer bandage, Double compression bandage and Cohesive bandage
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSpain
- Study dates
- 10 Aug 2014to 10 Jan 2020
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women after breast cancer surgery undergoing upper limb lymphedema not previously treated
- Having more than two centimeters between two adjacent measurements between the lymphedematous and the contralateral upper limb
- The presence of heaviness, tension or fovea in the affected limb
- More than six months post-surgery or radiation to eliminate the possibility of being a post-chirurgical oedema
Who cannot join
- Bilateral breast cancer surgery
- Only hand lymphedema
- Active cutaneous infection
- A loco-regional cancer recurrence
- The impossibility of complete all the physical therapy sessions
- A primary lymphedema
- Women with lymphedema symptoms like thickness and heaviness in the upper limb but without a difference of two centimeters in two adjacent points
- Any contraindication to physiotherapy
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University of Alcalá. FPSM research group. HUPA
Alcalá de Henares, Madrid, 28805
Physiotherapy in women´s health research group. University of Alcalà
Alcalà de Henares, Madrid, 28871
About this study
Official title: Compression Bandages in Upper Limb Lymphedema After Breast Cancer
Despite different types of bandages are using in the lymphedema treatment, numerous of them have not been directly compared. The aim of this study is to compare the efficacy of five different kinds of bandages on limb volume and lymphedema-related symptoms. It was also measured as secondary variables the comfort of the bandage related by the participants and the directly cost of each kind of bandage during the treatment.
- Conditions
- Lymphedema
- Being tested
- Multilayer bandage, Double compression bandage, Cohesive bandage, Adhesive compression bandage, Kinesiotaping bandage
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilayer bandageDevice
See arm/group descriptions
Double compression bandageDevice
See arm/group descriptions
Cohesive bandageDevice
See arm/group descriptions
Adhesive compression bandageDevice
See arm/group descriptions
Kinesiotaping bandageDevice
See arm/group descriptions
Manual lymphatic drainage (MLD) + Intermittent Pneumatic CompressionOther
MLD using a modification of the strokes described by Leduc will be applied to lymphedema "resorption". It will be included resorption maneuver in the oedematous areas of the affected limb, in cranial to caudal direction, since the physiotherapist seeing a change in the tissue qualities of the oedema. Then, the subjects will be received thirty minutes of Intermittent Pneumatic Compression ("EureducTM") with a pression of 40 mmHg.
Upper limb exercisesOther
After the bandage will be put, proprioceptive neuromuscular facilitation exercises without resistance in two diagonal in asymmetrical reciprocal patterns with the affected limb will be taught. The first diagonal into flexion from hitch hike to swat fly, and into extension from swat fly to hitch hike, and the second diagonal from hand in opposite pocket to carry tray, and into extension from carry tray to hand in opposite pocket. These exercises must be done at home two times per day, ten repetitions each exercise.
Educational strategyBehavioural
Instructions about lymphatic system anatomy and pato-physiology, the prevention and identification of possible lymphedema complication or infection, how to use and exercise this arm, avoidance of trauma, injury, an excess of heat and arm constriction.
| Study group | Role | What they receive |
|---|---|---|
| Multilayer bandage group | Experimental | Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + multilayer bandage consisting of three layers. The first was a 100% cotton tubular bandage which will be directly placed on the skin to prevent any injury ("Tubinylex TM"). The second layer is a paddle with the purpose of unify and increase pressure (Emulsified Latex FoamTM 8mm, Thuasne, France); and the third layer of inelastic bandages (6, 8 and/or 10 cm Rosidal K Short Stretch Bandage, Germany). All the bandage layers will be placed from caudal to cranial in a circular disposition, overlapping in one third the previous layer for a correctly cover of the limb and not to leave open spaces. The cotton tubular bandage and the short-stretch bandage could be cleaned without losing their material properties. Receives: Device: Multilayer bandage; Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression; Other: Upper limb exercises; Behavioral: Educational strategy |
| Simplified multilayer bandage group | Experimental | Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + double compression bandage consisting of two layers, made up of a first rigid cotton bandage (11 cm Bande coton Short Stretch; Thuasne, France) and a second elastic bandage ("BiflexTM" 16 light; Thuasne, France). The two layers will be placed caudal to cranial in a circular manner, overlapping in one third the previous layer. The elastic bandage have squares drawn to help to the physiotherapist to control the stretch they given to the bandage. The two bandages could be cleaning without losing their properties. If there was any oedema concentration or a fibrous place, a paddle pad will be put in these places ("Mobiderm TM", Thuasne, France). Receives: Device: Double compression bandage; Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression; Other: Upper limb exercises; Behavioral: Educational strategy |
| Cohesive bandage group | Experimental | Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + cohesive bandage consisting of a single short-stretched layer that will be put directly on the subject skin and stick on itself (10cm 3M CobanTM Minnesota Mining and Manufacturing Co, United States). It will be placed in a circular manner distal to cranial with a paddle pad in the elbow fold not to damage this moving part. This bandage will be reused twice in the same subject. Receives: Device: Cohesive bandage; Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression; Other: Upper limb exercises; Behavioral: Educational strategy |
| Adhesive compression bandage group | Experimental | Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + adhesive compression bandage consisting of an elastic bandage ("BiplastTM" Thuasne, France. Measures: 10cm x 2,5 m) which will put over a pre-tape bandage not to damage the skin. It will be placed in a circular disposition from distal to cranial. In each physiotherapy session, the bandage has to be replaced with a new one. Receives: Device: Adhesive compression bandage; Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression; Other: Upper limb exercises; Behavioral: Educational strategy |
| Kinesiotaping bandage group | Experimental | Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + kinesiotaping bandage consisting of K-Active" Tape. The k-tape will be pasted directly on the skin and put longitudinally in thin bands in a cranio-caudal disposition. The width of the bandage will be of 5cm, and will be cut in four bands that will cover all the upper limb cranial to caudal in a spiral way surrounded it. The bandage will be placed moving the limb into internal and external rotation for putting the skin in a little stretch without lengthen the tape. Receives: Device: Kinesiotaping bandage; Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression; Other: Upper limb exercises; Behavioral: Educational strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arm volume
To assess the volume of the limb it will be used the circumference measurement. The assessment will be with the subject in upright position with the arm placed on a table, the forearm relaxed on the table, the shoulder in a neutral rotation, a flexion of 45º of the elbow, and forearms in supine position. The reference will be the elbow fold where was measure the circumference of the limb in 5cm intervals. The circumference measurements will be converted into volume values with the truncated cone formula in each 5 centimeters long.
Measured: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
Change in heath related quality of life lymphedema
It will be assessed by Lymphedema specific PRO instrument: Upper Limb Lymphedema (ULL)27 spanish validated version
Measured: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
Secondary outcomes (1)
Change in comfort of the bandage
Numeric scale ranging from 0-10: 0 comfortable - 10: very uncomfortable
Measured: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start10 Aug 2014
- Primary completionSep 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies 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
- Model description
- 5 goups: Multilayer bandage group; Double compression bandage group; Cohesive bandage group; Adhesive compression bandage group; Kinesiotaping bandage group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Torres Lacomba, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250364
- Sponsor's protocol ID
- 18/2010
- Acronym
- CB-ULL
- Status last verified
- Jun 2020
- First submitted
- 4 Aug 2017
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Bandages in Upper Limb Lymphedema After Breast Cancer
- ClinicalTrials.gov ID
- NCT03250364
- Acronym / sponsor ID
- CB-ULL / 18/2010
- Conditions
- Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 10 Aug 2014 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 15 Aug 2017 (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.
Despite different types of bandages are using in the lymphedema treatment, numerous of them have not been directly compared. The aim of this study is to compare the efficacy of five different kinds of bandages on limb volume and lymphedema-related symptoms. It was also measured as secondary variables the comfort of the bandage related by the participants and the directly cost of each kind of bandage during the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- 5 goups: Multilayer bandage group; Double compression bandage group; Cohesive bandage group; Adhesive compression bandage group; Kinesiotaping bandage group
| Arm | Type | Receives |
|---|---|---|
| Multilayer bandage group | Experimental | Device: Multilayer bandage, Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression, Other: Upper limb exercises, Behavioral: Educational strategyManual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + multilayer bandage consisting of three layers. The first was a 100% cotton tubular bandage which will be directly placed on the skin to prevent any injury ("Tubinylex TM"). The second layer is a paddle with the purpose of unify and increase pressure (Emulsified Latex FoamTM 8mm, Thuasne, France); and the third layer of inelastic bandages (6, 8 and/or 10 cm Rosidal K Short Stretch Bandage, Germany). All the bandage layers will be placed from caudal to cranial in a circular disposition, overlapping in one third the previous layer for a correctly cover of the limb and not to leave open spaces. The cotton tubular bandage and the short-stretch bandage could be cleaned without losing their material properties. |
| Simplified multilayer bandage group | Experimental | Device: Double compression bandage, Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression, Other: Upper limb exercises, Behavioral: Educational strategyManual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + double compression bandage consisting of two layers, made up of a first rigid cotton bandage (11 cm Bande coton Short Stretch; Thuasne, France) and a second elastic bandage ("BiflexTM" 16 light; Thuasne, France). The two layers will be placed caudal to cranial in a circular manner, overlapping in one third the previous layer. The elastic bandage have squares drawn to help to the physiotherapist to control the stretch they given to the bandage. The two bandages could be cleaning without losing their properties. If there was any oedema concentration or a fibrous place, a paddle pad will be put in these places ("Mobiderm TM", Thuasne, France). |
| Cohesive bandage group | Experimental | Device: Cohesive bandage, Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression, Other: Upper limb exercises, Behavioral: Educational strategyManual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + cohesive bandage consisting of a single short-stretched layer that will be put directly on the subject skin and stick on itself (10cm 3M CobanTM Minnesota Mining and Manufacturing Co, United States). It will be placed in a circular manner distal to cranial with a paddle pad in the elbow fold not to damage this moving part. This bandage will be reused twice in the same subject. |
| Adhesive compression bandage group | Experimental | Device: Adhesive compression bandage, Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression, Other: Upper limb exercises, Behavioral: Educational strategyManual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + adhesive compression bandage consisting of an elastic bandage ("BiplastTM" Thuasne, France. Measures: 10cm x 2,5 m) which will put over a pre-tape bandage not to damage the skin. It will be placed in a circular disposition from distal to cranial. In each physiotherapy session, the bandage has to be replaced with a new one. |
| Kinesiotaping bandage group | Experimental | Device: Kinesiotaping bandage, Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression, Other: Upper limb exercises, Behavioral: Educational strategyManual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + kinesiotaping bandage consisting of K-Active" Tape. The k-tape will be pasted directly on the skin and put longitudinally in thin bands in a cranio-caudal disposition. The width of the bandage will be of 5cm, and will be cut in four bands that will cover all the upper limb cranial to caudal in a spiral way surrounded it. The bandage will be placed moving the limb into internal and external rotation for putting the skin in a little stretch without lengthen the tape. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women after breast cancer surgery undergoing upper limb lymphedema not previously treated
- Having more than two centimeters between two adjacent measurements between the lymphedematous and the contralateral upper limb
- The presence of heaviness, tension or fovea in the affected limb
- More than six months post-surgery or radiation to eliminate the possibility of being a post-chirurgical oedema
Key exclusion criteria (8 listed)
- Bilateral breast cancer surgery
- Only hand lymphedema
- Active cutaneous infection
- A loco-regional cancer recurrence
- The impossibility of complete all the physical therapy sessions
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 |
|---|---|---|
| Multilayer bandageSee arm/group descriptions | Device | Multilayer bandage group |
| Double compression bandageSee arm/group descriptions | Device | Simplified multilayer bandage group |
| Cohesive bandageSee arm/group descriptions | Device | Cohesive bandage group |
| Adhesive compression bandageSee arm/group descriptions | Device | Adhesive compression bandage group |
| Kinesiotaping bandageSee arm/group descriptions | Device | Kinesiotaping bandage group |
| Manual lymphatic drainage (MLD) + Intermittent Pneumatic CompressionMLD using a modification of the strokes described by Leduc will be applied to lymphedema "resorption". It will be included resorption maneuver in the oedematous areas of the affected limb, in cranial to caudal direction, since the physiotherapist seeing a change in the tissue qualities of the oedema. Then, the subjects will be received thirty minutes of Intermittent Pneumatic Compression ("EureducTM") with a pression of 40 mmHg. | Other | Adhesive compression bandage group, Cohesive bandage group, Kinesiotaping bandage group, Multilayer bandage group, Simplified multilayer bandage group |
| Upper limb exercisesAfter the bandage will be put, proprioceptive neuromuscular facilitation exercises without resistance in two diagonal in asymmetrical reciprocal patterns with the affected limb will be taught. The first diagonal into flexion from hitch hike to swat fly, and into extension from swat fly to hitch hike, and the second diagonal from hand in opposite pocket to carry tray, and into extension from carry tray to hand in opposite pocket. These exercises must be done at home two times per day, ten repetitions each exercise. | Other | Adhesive compression bandage group, Cohesive bandage group, Kinesiotaping bandage group, Multilayer bandage group, Simplified multilayer bandage group |
| Educational strategyInstructions about lymphatic system anatomy and pato-physiology, the prevention and identification of possible lymphedema complication or infection, how to use and exercise this arm, avoidance of trauma, injury, an excess of heat and arm constriction. | Behavioural | Adhesive compression bandage group, Cohesive bandage group, Kinesiotaping bandage group, Multilayer bandage group, Simplified multilayer bandage group |
Primary outcome
Change in arm volume
Time frame: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
To assess the volume of the limb it will be used the circumference measurement. The assessment will be with the subject in upright position with the arm placed on a table, the forearm relaxed on the table, the shoulder in a neutral rotation, a flexion of 45º of the elbow, and forearms in supine position. The reference will be the elbow fold where was measure the circumference of the limb in 5cm intervals. The circumference measurements will be converted into volume values with the truncated cone formula in each 5 centimeters long.
Change in heath related quality of life lymphedema
Time frame: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
It will be assessed by Lymphedema specific PRO instrument: Upper Limb Lymphedema (ULL)27 spanish validated version
1 secondary outcome
Change in comfort of the bandage
Time frame: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after 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 4 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Lymphedema
RecruitingObservational study
A Prospective Natural History Study of Lymphatic Anomalies
Lymphatic Diseases, Lymphatic Abnormalities
RecruitingObservational study
Use of Reconstructive Microsurgery for the Treatment of Lymphedema
Lymphedema
Recruiting
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
Lymphedema, Breast Cancer
Recruiting
Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery
Breast Cancer
Active, not recruitingPhase 3
Hypofractionated LocoRegional Radiotherapy in Breast Cancer
Breast Neoplasms, Radiotherapy
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multilayer bandage, Double compression bandage and Cohesive bandage in people with Lymphedema, run by University of Alcala at 2 sites 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 4 inclusion and 8 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 in arm volume (time frame: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention). 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 4 Jun 2020.