Chronic Venous InsufficiencyMLDCVINCT01899482
Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial
A study testing Manual Lymphatic Drainage and Education in people with Chronic Venous Insufficiency, run by Technical University of Lisbon at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- Manual Lymphatic Drainage and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 sitePortugal
- Study dates
- Jul 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnose of chronic venous insufficiency class C3-5 for Clinical-Etiological-Anatomical-Pathological classification (CEAP).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Saúde Dr. Lopes Dias
Castelo Branco, 6000-270
About this study
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
- Being tested
- Manual Lymphatic Drainage, Education
- Keywords
- Venous Insufficiency, Physical Therapy Techniques, Manual Lymphatic Drainage
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Lymphatic DrainageOther
EducationBehavioural
Behavioral education.
| Study group | Role | What they receive |
|---|---|---|
| Manual Lymphatic Drainage | Experimental | One educational session in group, and 10 individual sessions of manual lymphatic drainage in lower extremity, during approximately one month. Receives: Other: Manual Lymphatic Drainage; Behavioral: Education |
| Control | Active comparator | One educational session in group. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Evaluated by portuguese version of Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-2).
Measured: 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 by leg perimeter.
Measured: 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
With Visual Analogue Scale was assessed: pain, fatigue, heaviness, itching, sKin irritation, cramps and other.
Measured: 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
Venous reflux and anterograde flow during manual leg compression, by duplex ultrasound in femoral vein, great saphenous vein, popliteal vein and small saphenous vein.
Measured: 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 by Venous Clinical Severity Score.
Measured: 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
Evaluated by Biodex system 3 pro isokinetic dynamometer.
Measured: 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)
Sel-reported functional status
Evaluated by Portuguese version of Functional Status Questionnaire (FSQ).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Lisbon
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, Escola Superior de Saúde Dr. Lopes Dias, Portugal
- Responsible party
- Principal investigator, Rute Sofia dos Santos Crisóstomo, Technical University of Lisbon
- Investigators
- Paulo AS Armada-da-Silva, PhD, Principal investigator, Faculdade de Motricidade Humana, Estrada da Costa, 1499-002 Cruz Quebrada,Portugal, Phone number: +351214149248, parmada@fmh.utl.pt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899482
- Sponsor's protocol ID
- SFRH/BD/62673/2009
- Acronym
- MLDCVI
- Status last verified
- Jul 2013
- First submitted
- 10 Jul 2013
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: http://www.archives-pmr.org/article/S0003-9993(14)01127-7/abstract
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01899482
- Acronym / sponsor ID
- MLDCVI / SFRH/BD/62673/2009
- Conditions
- Chronic Venous Insufficiency
- Keywords
- Venous Insufficiency, Physical Therapy Techniques, Manual Lymphatic Drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Technical University of LisbonUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, Escola Superior de Saúde Dr. Lopes Dias, Portugal
- Study start
- Jul 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Lymphatic Drainage | Experimental | Other: Manual Lymphatic Drainage, Behavioral: EducationOne educational session in group, and 10 individual sessions of manual lymphatic drainage in lower extremity, during approximately one month. |
| Control | Active comparator | Behavioral: EducationOne educational session in group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnose of chronic venous insufficiency class C3-5 for Clinical-Etiological-Anatomical-Pathological classification (CEAP).
Key exclusion criteria (8 listed)
- Severe cardiac insufficiency,
- Acute venous or arterial obstruction,
- Arterial insufficiency, renal insufficiency,
- Uncompensated thyroid dysfunction,
- Pregnancy, neoplastic pathology,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Lymphatic Drainage | Other | Manual Lymphatic Drainage |
| EducationBehavioral education. | Behavioural | Control, Manual Lymphatic Drainage |
Primary outcome
Quality of Life
Time frame: 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)
Evaluated by portuguese version of Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-2).
6 secondary outcomes
Leg edema
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Sel-reported functional status
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Individual participant dataSharing planned: Yes. http://www.archives-pmr.org/article/S0003-9993(14)01127-7/abstract
Related trials for Chronic Venous Insufficiency
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
Active, not recruitingObservational study
Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty
Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo AS Armada-da-Silva, PhD principal investigator
Faculdade de Motricidade Humana, Estrada da Costa, 1499-002 Cruz Quebrada,Portugal, Phone number: +351214149248, parmada@fmh.utl.pt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Lymphatic Drainage and Education in people with Chronic Venous Insufficiency, run by Technical University of Lisbon at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.