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Trial record 13 of 288 for:    Lymphedema

Compression Bandages in Upper Limb Lymphedema (CB-ULL)

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ClinicalTrials.gov Identifier: NCT03250364
Recruitment Status : Active, not recruiting
First Posted : August 15, 2017
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Torres Lacomba, University of Alcala

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Lymphedema Device: Multilayer bandage Device: Double compression bandage Device: Cohesive bandage Device: Adhesive compression bandage Device: Kinesiotaping bandage Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression Other: Upper limb exercises Behavioral: Educational strategy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 5 goups: Multilayer bandage group; Double compression bandage group; Cohesive bandage group; Adhesive compression bandage group; Kinesiotaping bandage group
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compression Bandages in Upper Limb Lymphedema After Breast Cancer
Actual Study Start Date : August 10, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Experimental: Multilayer bandage group
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; and a final layer of short-stretch bandage of different sizes depending on the place of the upper limb (UL): 8 cm width for the forearm and 10 cm for the arm ("ComprilanTM"). 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.
Device: Multilayer bandage
See arm/group descriptions

Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression
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.

Other: Upper limb exercises
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.

Behavioral: Educational strategy
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.

Experimental: Double compression bandage group
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 X 4m "MedicaTM" 315 anti oedema; 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).
Device: Double compression bandage
See arm/group descriptions

Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression
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.

Other: Upper limb exercises
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.

Behavioral: Educational strategy
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.

Experimental: Cohesive bandage group
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 ("Medi-Rip TM LF Hartmann", Germany. Measures: 7,5 cm x 4,5 m). 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.
Device: Cohesive bandage
See arm/group descriptions

Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression
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.

Other: Upper limb exercises
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.

Behavioral: Educational strategy
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.

Experimental: Adhesive compression bandage group
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.
Device: Adhesive compression bandage
See arm/group descriptions

Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression
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.

Other: Upper limb exercises
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.

Behavioral: Educational strategy
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.

Experimental: Kinesiotaping bandage group
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.
Device: Kinesiotaping bandage
See arm/group descriptions

Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression
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.

Other: Upper limb exercises
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.

Behavioral: Educational strategy
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.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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 ]
    Numeric scale ranging from 0-10: 0 comfortable - 10: very uncomfortable



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women after breast cancer surgery undergoing upper limb lymphedema
  • 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 three months post-surgery or radiation to eliminate the possibility of being a post-chirurgical oedema

Exclusion criteria will be:

  • Bilateral breast cancer surgery
  • A lymphedema treatment in the last six months
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250364


Locations
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Spain
Physiotherapy in women´s health research group. University of Alcalà
Alcalà de Henares, Madrid, Spain, 28871
University of Alcalá. FPSM research group. HUPA
Alcalá de Henares, Madrid, Spain, 28805
Sponsors and Collaborators
University of Alcala

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Responsible Party: Maria Torres Lacomba, Professor, University of Alcala
ClinicalTrials.gov Identifier: NCT03250364     History of Changes
Other Study ID Numbers: 18/2010
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases