Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial

NCT01899482 | Completed DMC

• 1 other identifier: SFRH/BD/62673/2009
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Venous Insufficiency

Keywords

Venous Insufficiency; Physical Therapy Techniques; Manual Lymphatic Drainage

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  Evaluated by portuguese version of Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-2).

  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 (6)

• Leg edema

  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).

• Lower extremity symptoms

  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).

• Hemodynamic evidence of severity of chronic venous disease

  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).

• Clinical severity of chronic venous insufficiency

  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).

• Calf muscle strength and ankle range of motion

  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)

Study Arms (2)

Manual Lymphatic Drainage

EXPERIMENTAL

One educational session in group, and 10 individual sessions of manual lymphatic drainage in lower extremity, during approximately one month.

Other: Manual Lymphatic Drainage; Behavioral: Education

Control

ACTIVE COMPARATOR

One educational session in group.

Behavioral: Education

Interventions

Manual Lymphatic Drainage OTHER

Manual Lymphatic Drainage

Education BEHAVIORAL

Behavioral education.

Control; Manual Lymphatic Drainage

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Technical University of Lisbon: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• Escola Superior de Saúde Dr. Lopes Dias, Portugal: collaborator

Study Sites (1)

Escola Superior de Saúde Dr. Lopes Dias

Castelo Branco, 6000-270, Portugal

Location

MeSH Terms

Conditions

Venous Insufficiency

Interventions

Manual Lymphatic Drainage; Educational Status

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation; Socioeconomic Factors; Population Characteristics

Study Officials

• Paulo AS Armada-da-Silva, PhD

  Faculdade de Motricidade Humana, Estrada da Costa, 1499-002 Cruz Quebrada,Portugal, Phone number: +351214149248, parmada@fmh.utl.pt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 15, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 24, 2016

Record last verified: 2013-07

Data Sharing

• IPD Sharing: Will share

Locations

PT (1)