Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000272998
Ethics application status
Approved
Date submitted
2/03/2011
Date registered
15/03/2011
Date last updated
15/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Manual Lymphatic Drainage to treat leg edema at late pregnancy
Scientific title
The objective of the study was to evaluate the effectiveness and safety of the lymphatic manual drainage (LMD) in the treatment of women with edema of legs in the third quarter of pregnancy.
Secondary ID [1] 259723 0
nil
Universal Trial Number (UTN)
U1111-1119-7085
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
women with edema of legs in the third quarter of pregnancy 261301 0
Condition category
Condition code
Reproductive Health and Childbirth 259448 259448 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants had at least 28 weeks of gestation and clinical diagnosis of edema of legs. After signed an informed consent form the women initiate a drainage sessions of 40 minutes each by a physiotherapist who conducted the study.The sessions were scheduled at the same days of prenatal consultations until childbirth. The procedure of the drainage followed the standard technique chosen by the researcher:
Deep slip - with flat hands, the therapist exerts pressure and a displacement of it following the centripetal direction of lymphatic vessels.
Superficial slip - run the same way that the deep, but with less pressure.
Lymphatic pumping maneuver - three soft compressions performed with the palm side of second to fifth finger of the hands of the physiotherapist on the lymph nodes.

First, the woman is positioned in lateral recumbency with the limb to be drained, supported and relaxed on a soft roll of 20cm in diameter, while the other remains in flexion. Then the skin of the limb to be massaged is hydrated with oil.
The inguinal region is pumped. Superficial and deep slips are made in the thigh following the direction of the lymph vessels, moving the lymph towards the inguinal lymph nodes in the region. Again, the nodes are pumped. These sequences of moves are performed repeatedly with an average time spent from 3 to 5 minutes.
After draining the thigh, the popliteal lymph nodes are pumped and followed by deep and shallow landslides in the calf. Again, the lymph nodes (popliteal) get pumping. A new iteration of landslides is performed in the thigh causing the liquid to the groin, where it is pumped again. The same procedure is repeated with a mean time of 4 to 8 minutes
Finally, the slips are done on foot and the whole process done in the calf and thigh is sequentially repeated leading finally to the lymph nodes of inguinal region. In the feet, the procedure is repeated many times, this is a region where there are large concentrations of edema. The average duration of foot massage is 10 minutes.
The entire procedure is repeated in the contralateral lower limb.
Intervention code [1] 264147 0
Other interventions
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262255 0
5 circumference measures of extermities of the leg.
The local measures were chosen by the researcher:
1. measure circumference around the head of the metatarsal
2. circumference measured on the tarsal joint (from the measurement taken at one of the alignment between the fold of skin at the end of the tibia to the proximal phalanx of the 3rd tarsus)
3.circumference measured around the ankle on the medial malleolus
4.circumference measured on the region's most prominent calf (location determined from a point between the alignment between the lateral malleolus and lateral tibial condyle)
5.circumference measured 2 to 3 inches (previously determined) from the top edge of the patella

All data collected were completed in a record-set and stored by the researcher.
Timepoint [1] 262255 0
before and after massage
Primary outcome [2] 262256 0
arterial blood pressure
The measurement of blood pressure was measured with patient in left lateral position. The arm remains in mild flexion and relaxed. The sphygmomanometer Tycos ? is placed (2.5 cm) above the bend of the elbow, the stethoscope is positioned over the brachial artery identified digitally.
The cuff is inflated to approximately 180mmHg and then gradually deflate. With the stethoscope to the sound oscillation in the brachial artery is accompanied by the strongest disappear (Korotkoff sounds). At this point are recorded respectively the systolic (maximum) and diastolic (minimum), by viewing the unit of pressure values??.
Timepoint [2] 262256 0
before and after massage
Primary outcome [3] 262257 0
Qualitative questionnaire:
The questionnaires were created by the researcher. The questionnaires had engaged a visual analogue scale for evaluating pain. The same scale was adapted for the symptoms of tingling, heavy legs, swelling and discomfort caused by (not scientifically validated scales).
Timepoint [3] 262257 0
before and after each session.
Secondary outcome [1] 273412 0
none
Timepoint [1] 273412 0
none

Eligibility
Key inclusion criteria
All participants had at least 28 weeks of gestation and clinical diagnosis of edema of legs. All participants were deemed healthy.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
dermatologic desease, limphatic desease, high blood pressure, cardiac desease, infections on the leg, polyhydramnios, skin desease, kidney desease, thrombosis, varises,tumors.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
It was conducted a non controled study before/after with 20 pregnant women registered in the program of Prenatal Care at the Center of Integral Attention to the Woman's Health (CAISM) of Unicamp.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3283 0
Brazil
State/province [1] 3283 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 264603 0
University
Name [1] 264603 0
Universidade estadual de campinas - UNICAMP
Country [1] 264603 0
Brazil
Primary sponsor type
Commercial sector/Industry
Name
Fapesp
Address
Rua Pio XI, 1500 - Alto da Lapa - CEP 05468-901 - Sao Paulo/SP - Brasil
Country
Brazil
Secondary sponsor category [1] 263742 0
None
Name [1] 263742 0
Address [1] 263742 0
Country [1] 263742 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260597 0
Comite de Etica em pesquisa da Faculdade de Ciencias Medicas da UNICAMP
Ethics committee address [1] 260597 0
Ethics committee country [1] 260597 0
Brazil
Date submitted for ethics approval [1] 260597 0
06/10/2006
Approval date [1] 260597 0
04/12/2006
Ethics approval number [1] 260597 0
576/2006

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32304 0
Address 32304 0
Country 32304 0
Phone 32304 0
Fax 32304 0
Email 32304 0
Contact person for public queries
Name 15551 0
Cristina Wenderholm Spaggiari
Address 15551 0
R. Antonio Augusto de Almeida, 1272
Campinas, SP
CEP: 13083-755
Country 15551 0
Brazil
Phone 15551 0
55 19-91324894
Fax 15551 0
Email 15551 0
[email protected]
Contact person for scientific queries
Name 6479 0
JOAO LUIZ PINTO E SILVA
Address 6479 0
Universidade Estadual de Campinas . Faculdade de Educaçao Ciencias Medicas
Rua Tessalia Vieira de Camargo 126
CEP:13084971

Campinas - SP
Country 6479 0
Brazil
Phone 6479 0
55 19-35219304
Fax 6479 0
Email 6479 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.