Lymphedema
Conditions
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.
Interventions
DEVICEMultilayer bandage
See arm/group descriptions
DEVICEDouble compression bandage
See arm/group descriptions
DEVICECohesive bandage
See arm/group descriptions
DEVICEAdhesive compression bandage
See arm/group descriptions
DEVICEKinesiotaping bandage
See arm/group descriptions
OTHERManual 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.
OTHERUpper 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.
BEHAVIORALEducational 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.
Sponsors
University of Alcala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
5 goups: Multilayer bandage group; Double compression bandage group; Cohesive bandage group; Adhesive compression bandage group; Kinesiotaping bandage group
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
will be: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in arm volume | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in comfort of the bandage | 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 |
Countries
Spain
Outcome results
None listed