Clinical trial NCT01899482: Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial
Official title: Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Venous Insufficiency
Keywords: Venous Insufficiency
Physical Therapy Techniques
Manual Lymphatic Drainage
Lead sponsor: Technical University of Lisbon
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
name: Escola Superior de Saúde Dr. Lopes Dias, Portugal
First posted: 2013-07-15
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare functional status and quality of life of a group of patients with chronic venous insufficiency treated with manual lymphatic drainage with a group not treated with manual lymphatic drainage.

Investigators hypothesized that manual lymphatic drainage can improve:

* quality of life,
* functional status,
* calf muscle strength,
* ankle range of motion,
* edema,
* severity of disease,
* and symptoms.


Eligibility criteria: Inclusion Criteria:

* Diagnose of chronic venous insufficiency class C3-5 for Clinical-Etiological-Anatomical-Pathological classification (CEAP).

Exclusion Criteria:

* Severe cardiac insufficiency,
* Acute venous or arterial obstruction,
* Arterial insufficiency, renal insufficiency,
* Uncompensated thyroid dysfunction,
* Pregnancy, neoplastic pathology,
* Systemic or limb infection,
* Recent musculoskeletal injury in the lower limb,
* Peripheral neuropathy in the lower limb.

Primary outcomes:
measure: Quality of Life
timeFrame: Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days)
Secondary outcomes:
measure: Leg edema
timeFrame: Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days).
measure: Lower extremity symptoms
timeFrame: Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days).
measure: Hemodynamic evidence of severity of chronic venous disease
timeFrame: Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days).
measure: Clinical severity of chronic venous insufficiency
timeFrame: Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days).
measure: Calf muscle strength and ankle range of motion
timeFrame: Assessed at aseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days)
measure: Sel-reported functional status
timeFrame: Assessed at aseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days)
Other outcomes:
Locations:
city: Castelo Branco
country: Portugal
facility: Escola Superior de Saúde Dr. Lopes Dias
Study officials:
affiliation: Faculdade de Motricidade Humana, Estrada da Costa, 1499-002 Cruz Quebrada,Portugal, Phone number: +351214149248, parmada@fmh.utl.pt
name: Paulo AS Armada-da-Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References: