Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001027909
Ethics application status
Not yet submitted
Date submitted
22/09/2011
Date registered
28/09/2011
Date last updated
28/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in the portal flow after Heiling`s pumping technique of liver to individuals with hemorrhoid syndrome
Scientific title
Changes in the portal flow after Heiling's pumping technique of liver to 50 individuals with hemorrhoid syndrome
Secondary ID [1] 263102 0
Nill
Universal Trial Number (UTN)
U1111-1124-7285
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemorrhoids 270841 0
Portal flow 270842 0
Condition category
Condition code
Oral and Gastrointestinal 271024 271024 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two groups: patients with hemorrhoidal syndrome is submitted to the pumping technique of the liver (Group 1) and patients with syndrome hemorrhoidal those who perform a maneuver placeblo (Group 2):

Group 1:
Subject position: supine (Tredelemburg) with knees bent
Position of Therapist: Standing at the patient's left, at the height of the abdomen.

Hand position:
The left hand goes below the costal margin to lift the chest wall
The right hand rests on the lower right side of the chest to compress the liver through the chest wall.

Running technique
The bottom hand up the ribs while the top has a compression
The manipulation is done by following the movement
breathing. In this study technique asking the patient to breathe deeply, during expiration to compress costal with our hands and let our contacts deep breath.
Be repeated for 10 respiratory cycles, the technique will last for 2 minutes.
Intervention code [1] 269441 0
Treatment: Other
Comparator / control treatment
Group 2: Maneuver placebo: Ask the patient to breathe, our lower and upper hand accompany respiratory motion without exerting any pressure on the rib cage.
Be repeated for 10 respiratory cycles, the technique will last for 2 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 279684 0
Demonstrate the variation of portal venous flow after technical
liver pumping hemorrhoidal syndrome Doppler ultrasound
Timepoint [1] 279684 0
Baseline
Secondary outcome [1] 294202 0
Determine differences vertebrae algometer pre and postintervention. Using a pressure algometer to measure pain intensity in the cervical and thoracic spinous processes.
The algometer is a measuring device calibrated with a pressure of 1 cm2 circular base, so that measurements are given in Kg/cm2 or Newton (Nw)
Timepoint [1] 294202 0
Baseline

Eligibility
Key inclusion criteria
Men and women aged between 18 and 65.
Subjects diagnosed with hemorrhoids.
Tolerating supine.
Informed consent signed.
Do not meet any criteria for exclusion
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with recent rib fractures who can not tolerate compression matter.
Pregnant women.
Cancer primitive or metastatic.
Intra-abdominal infection or inflammation in acute appendicitis, acute cholecystitis and hepatitis, gastrointestinal bleeding.
Polycystic liver or heart hepatobiliar.
Chronic liver disease of any cause: jaundice, hepatomegaly,
splenomegaly, portal hypertension.
Heart failure descompensada.
liver transplantation.
Subjects with chemotherapy and / or radiotherapy.
Subjects with psychotic problems.
Abdominal circumference greater than 88 cm in women and 102 cm in the man.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This trial is is randomised controlled trial.
Participants who meet the inclusion criteria were divided into groups through random sampling sealed envelope. Will be prepared "X" envelopes, which half will be the number 1 and half the number 2. Are mixed, and participants randomly removed, being removed from the rest chosen on envelopes. Be so formed two groups: an intervention group and a control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This trial use simple randomisation. Are mixed, and participants randomly removed, being removed from the rest chosen on envelopes. Be so formed two groups: an intervention group and a control group.
Ultimately obtained two groups: patients with hemorrhoidal syndrome is submitted to the pumping technique of the liver (Group 1) and patients with syndrome hemorrhoidal those who perform a maneuver placebo (Group 2)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A randomized clinical trial, ie an experimental study
intervention and random assignment (randomized) prospective,
longitudinal.
It aims to conduct a randomized clinical trial design
explanatory in nature, so experimental, triple blind, blind.
The masking technique used is the triple-blind
assessor blind strategy, the individual in any known
technique or group membership control or intervention, and
as the statistic ignores the subject's group assignment. On the other hand, there is any relationship between the evaluator and the
controller, giving this area more strength to the study.
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 3856 0
Spain
State/province [1] 3856 0
Madrid

Funding & Sponsors
Funding source category [1] 269915 0
Commercial sector/Industry
Name [1] 269915 0
Hitachi
Country [1] 269915 0
Spain
Primary sponsor type
Individual
Name
Elena Sonsoles Rodriguez L0pez
Address
C/ La zarza,20
Casarrubios del Monte
45950 Toledo
Country
Spain
Secondary sponsor category [1] 268925 0
Commercial sector/Industry
Name [1] 268925 0
Hitachi
Address [1] 268925 0
Sistemas integrales Medica. S.a.
Avda. Sistema Solar, 25
San Fernando de Henares
28030 Madrid
Country [1] 268925 0
Spain

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271882 0
Escuela de Osteopatia de Madrid
Ethics committee address [1] 271882 0
C/Saturnino Calleja, 1
28002 Madrid
Ethics committee country [1] 271882 0
Spain
Date submitted for ethics approval [1] 271882 0
28/09/2011
Approval date [1] 271882 0
Ethics approval number [1] 271882 0

Summary
Brief summary
For this study subjects were taken hemorrhoidal syndrome. Through ultrasound flow measurement algometry portal and the thoracic and cervical intended objectify the impact of pumping technique on liver portal flow.
So our hypothesis is that the osteopathic treatment of liver improves the speed of the portal vein flow, measured Doppler ultrasound, and modifies the tenderness of the vertebra cervical thoracic and correspondence, as measured algometry pressure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33192 0
Address 33192 0
Country 33192 0
Phone 33192 0
Fax 33192 0
Email 33192 0
Contact person for public queries
Name 16439 0
Elena rodriguez lopez
Address 16439 0
C/ La zarza, 20
Casarrubios del Monte
45950 Toledo
Country 16439 0
Spain
Phone 16439 0
0034-679336394
Fax 16439 0
Email 16439 0
elenasonsolesrodriguez@gmail.com
Contact person for scientific queries
Name 7367 0
elena rodriguez lopez
Address 7367 0
C/ La zarza, 20
Casarrubios del Monte
45950 Toledo
Country 7367 0
Spain
Phone 7367 0
0034-679336394
Fax 7367 0
Email 7367 0
elenasonsolesrodriguez@gmail.com

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

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