Lymphedema
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Residents in an endemic area of filariasis; of both sexes; age from 18 to 75 years old; who had lymphedema located in the leg, below the knee, unilaterally or bilaterally, ranked from stage II to stage V, according to Dreyer.
Exclusion criteria
Exclusion criteria: Will be excluded from the study patients with lymphedema above the knee (thigh), patients who are doing another treatment to reduce lymphedema, except patients on use of topical antifungal drugs and prophylactic antibiotics for secondary infections; have performed physical therapy for lymphedema in the three months prior to inclusion in the study; introduce infectious processes active and untreated during the project; present thrombophlebitis; have contraindications for manual lymphatic drainage (active neoplasms at the site of drainage, cellulitis, deep vein thrombosis in the acute phase, cardiac insufficiencies, liver and kidney desconpensada and uncontrolled hypertension); have contraindications for compressive bandaging (significant artery diseases in the lower limbs and neoplastic degeneration of lymphedema); present conditions that may compromise the sensitivity and also the functioning of the muscular system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome found: At the end of the study it was observed to reduce the volume of lymphedema in the intervention group in indirect measurement at all points of the circumference , obtaining the following reduction values ??(in centimeters) : zero : 0.72 ; Point 1 : 5.90 ; section 2 : 5.60; Section 3 : 5.90 ; Point 4 : 3.05 ; Section 5 : 0.70. Control group: the increase of lymphedema was found (and this outcome was not expected , but it was found): zero point : 0.98 ; Point 1 : 0.27; section 2 : 0.58; Section 3 : 0.52; Point 4 : 0.79; Section 5 : 0.30 . The volumes were no significant intra-group reduction, only between groups , yielding the following values ??: Group Intervention : 7.21% reduced volume and control group: 6.89% increased (this was not expected, but was found).;Primary outcome expected: Change in limb volume with lymphedema . Methods and parameters for measuring volume : Indirect measurement by perimetry ( using measuring tape drive in centimeters). It was established six perimetry points : apex of the patella (knee - zero point) , four circumference measurements every seven centimeters below this point , yet another measure in the foot, to seven cm in front of the medial malleolus . Direct measurement by volumetry , by calculating the truncated cone, in milliliters unit . In both measures were considered any change values ??( in numbers and percentage ) for both larger and for smaller. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1Expected secondary outcomes: . Change in quality of life. Methods and parameters to assess the quality of life assessed by the BREF Whoqol, developed by the World Health Organization and validated in Brazil, considering four domains: physical, psychological, social and environment. The total score for each domain ranges from 0 to 5, being interpreted as: between 1 and 2.9 mean poor quality of life (needs improvement); between 3 and 3.9 (regular); 4 of the 4,9 (good); and 5 (very good). Which they were considered either values ??and scores found, since the study was not known the quality of life of patients. . Change in functionality and mobility of the lower limbs. Methods and parameters to evaluate the functionality and mobility: was evaluated by the test Timed Up and Go (TUG-Test, the second unit and were considered any values ??found for both larger and for smaller.. . Change in body weight Methods and parameters to assess the body weight: the evaluation of body weight was made by weighing the anthropometric scale in kilograms unit.;Found secondary outcomes: Quality of life: There was an improvement in the quality of life values in the physical (within and between groups) and environment (intra group). Obtaining values: improvement of 0.36 in the physical domain score of 0.38 and the environment. And improves inter group in the physical domain of 0.64. No significant improvement in the rest of fields (psychological and social). Mobility and functionality of the lower limbs: it was no improvement in this outcome. Body weight: weight reduction was observed in the intervention group and 2.81% weight gain in the control group of 2.06%. The change in body weight was significant when comparing inter and intra group control group. And no significant intra group intervention. | — |
Countries
Brazil
Contacts
Fundação Oswaldo Cruz - Pernambuco