Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000669493
Ethics application status
Approved
Date submitted
24/04/2016
Date registered
23/05/2016
Date last updated
23/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in the portal flow and elastography after manual pumping technique of the liver to individuals with hepatic fibrosis
Scientific title
Changes in the portal flow and elastography after manual pumping technique of the liver to individuals with hepatic fibrosis
Secondary ID [1] 289075 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatic fibrosis 298523 0
Condition category
Condition code
Oral and Gastrointestinal 298605 298605 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
The pumping technique: To such end, the subject place in a supine position with knees bent and the therapist standing on the left hand side of the patient, near the abdominal area. The left hand goes under the costal border to lift the costal chest. The right hand rests on the lower chest on the right side to compress the liver through the costal wall. The lower hand lifts the ribs while the upper hand exerts compression. The patient is asked to inhale deeply, and on exhaling the compression is performed with the hands, and during deep inspiration. This will be repeated for 10 respiratory cycles. Thus, through the anteroposterior contact on the liver, using the costal inspiration, which lowers the diaphragm, the liver is
pumped
The intervention will be delivered by an osteopath with minimum 10 years experience
The intervention will be delivered as four weekly sessions for one month
Intervention code [1] 294578 0
Treatment: Other
Comparator / control treatment
Subjects in the Control Group followed exactly the same process for measurements, positions, contacts and breathing as the Experimental Group, with the only exception being the pumping. In lieu of any force, the therapist's hands will limited to accompanying the respiratory movements with no compression.
Control group
Placebo

Outcomes
Primary outcome [1] 298100 0
Evaluate the effects of the isolated liver pumping technique, on portal venous flow, using Doppler ultrasound
Timepoint [1] 298100 0
immediately following completion of treatment
Secondary outcome [1] 323179 0
Evaluate the effects of the isolated liver pumping technique, on elastography
Timepoint [1] 323179 0
immediately following completion of treatment

Eligibility
Key inclusion criteria
Inclusion criteria will be subjects of both sexes who have hepatic fibrosis, aged between 18 and 65 years, must have fasted for at least 8 hours and tolerating the supine position
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects presenting the following could not participate in the study (i) contraindication or intolerance to coastal compression, (ii) psychotic problems, (iii) primary cancer or current metastases, (iv) current gastrointestinal bleeding, (v) liver transplants ( vi) polycystic liver or hepatobiliary infarction (vii) intraabdominal infection or inflammation in acute phase, (viii)
decompensated heart failure (ix) subjects who are receiving chemotherapy and / or radiotherapy, (x) pregnant women

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)
The subjects will be formed through random ballots in sealed envelopes. An outside co-worker safeguard the sequence for those participating in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This trial use simple randomisation. Participants randomly removed, sealed envelopes with numbers 1 and 2 written. Be so formed two groups: an intervention group and a control group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/09/2016
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] 7835 0
Spain
State/province [1] 7835 0
Madrid

Funding & Sponsors
Funding source category [1] 293450 0
University
Name [1] 293450 0
University Camilo Jose Cela
Country [1] 293450 0
Spain
Primary sponsor type
University
Name
University Camilo Jose Cela
Address
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Country
Spain
Secondary sponsor category [1] 292272 0
None
Name [1] 292272 0
Address [1] 292272 0
Country [1] 292272 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294895 0
Camilo Jose Cela University
Ethics committee address [1] 294895 0
Ethics committee country [1] 294895 0
Spain
Date submitted for ethics approval [1] 294895 0
04/04/2016
Approval date [1] 294895 0
15/04/2016
Ethics approval number [1] 294895 0

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

Contacts
Principal investigator
Name 65378 0
Dr Elena Sonsoles Rodriguez Lopez
Address 65378 0
Camilo Jose Cela University
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Country 65378 0
Spain
Phone 65378 0
+34679336394
Fax 65378 0
Email 65378 0
[email protected]
Contact person for public queries
Name 65379 0
Elena Sonsoles Rodriguez Lopez
Address 65379 0
Camilo Jose Cela University
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Country 65379 0
Spain
Phone 65379 0
+34679336394
Fax 65379 0
Email 65379 0
[email protected]
Contact person for scientific queries
Name 65380 0
Elena Sonsoles Rodriguez Lopez
Address 65380 0
Camilo Jose Cela University
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Country 65380 0
Spain
Phone 65380 0
+34679336394
Fax 65380 0
Email 65380 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.