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Trial registered on ANZCTR


Registration number
ACTRN12615000410550
Ethics application status
Approved
Date submitted
25/02/2015
Date registered
30/04/2015
Date last updated
30/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in the pressure pain threshold in the spine after manual pumping of liver by an osteopath.
Scientific title
Changes in the pressure pain threshold in the cervical and dorsal vertebrae after manual pumping of liver by an osteopath in patients with pathophysiology related to liver function
Secondary ID [1] 286273 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Any disorder whose pathophysiology has been related with the function of the liver 294339 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294655 294655 0 0
Physiotherapy

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
Intervention code [1] 291295 0
Treatment: Other
Comparator / control treatment
Subjects in the Control Group follow 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] 294412 0
Evaluate the effects of the liver pumping technique, onthe pain threshold to pressure on the cervical and dorsal vertebrae, using algometer
Timepoint [1] 294412 0
immediately following completion of treatment
Secondary outcome [1] 314136 0
Evaluate the effects of the liver pumping technique, onthe pain threshold to pressure on the cervical and dorsal vertebrae, using algometer
Timepoint [1] 314136 0
30 minute following completion of treatment

Eligibility
Key inclusion criteria
Inclusion criteria will be subjects of both sexes who seek an osteopathy consultation for any disorder whose pathophysiology has been related with the function of the liver (spinal pains, headaches, sprained ankle ...), 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 costal compression, (ii) psychotic problems, (iii) primary cancer or current metastases, (iv) current gastrointestinal bleeding, (v) liver transplants ( vi) polycystic liver or hepatobiliary infarction (vii) intra-abdominal infection or inflammation in acute phase, (viii) chronic liver disease of any etiology, (ix) decompensated heart failure (x) subjects who are receiving chemotherapy
and / or radiotherapy, (xi) 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, assigning to the Experimental Group (EG) those subjects who draw a ballot with the number 1, and to the Control Group (CG) those subjects who drew a ballot with the number 2. 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, being removed from the rest chosen on envelopes, sealed envelopes with numbers 1 and 2 written. Be so formed two groups: an intervention group and a control group. Assigning to the Experimental Group (EG) those subjects who draw a ballot with the number 1, and to the Control
Group (CG) those subjects who drew a ballot with the number 2
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
29/05/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment outside Australia
Country [1] 6691 0
Spain
State/province [1] 6691 0
Madrid

Funding & Sponsors
Funding source category [1] 290828 0
Self funded/Unfunded
Name [1] 290828 0
Elena Rodriguez
Country [1] 290828 0
Spain
Primary sponsor type
Individual
Name
Elena Rodriguez Lopez
Address
pza nicaragua, 9, 9 A
Mostoles
28936 Madrid
Country
Spain
Secondary sponsor category [1] 289518 0
Individual
Name [1] 289518 0
Angel Oliva Pascual Vaca
Address [1] 289518 0
pza nicaragua, 9, 9 A
Mostoles
28936 Madrid
Country [1] 289518 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292450 0
SEFO- scientific european federation osteopaths
Ethics committee address [1] 292450 0
C/ San Felix de Alcala 4
28807 Alcala de Henares
Madrid
Ethics committee country [1] 292450 0
Spain
Date submitted for ethics approval [1] 292450 0
02/02/2015
Approval date [1] 292450 0
24/02/2015
Ethics approval number [1] 292450 0

Summary
Brief summary
The osteopathic treatment of the liver has been recommended in several types of disorders in order to increase and improve the liver function.
However, there are no studies to support its effectiveness.
Therefore, through the algometer, we inten to evaluate the effect of the osteopathic manual pumping of liver technique on changes in the pain of cervical and dorsal vertebrae in patients with different symptoms.
The conceptual hypothesis of our study will be that "the manual treatment of the liver improves the pain of cervical and dorsal vertebrae", so that a visceral manual operation may change the neural function of the viscera itself.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55318 0
Dr Elena Sonsoles Rodriguez Lopez
Address 55318 0
pza nicaragua, 9, 9 A
Mostoles
28936 Madrid
Country 55318 0
Spain
Phone 55318 0
+34679336394
Fax 55318 0
Email 55318 0
[email protected]
Contact person for public queries
Name 55319 0
Elena Sonsoles Rodriguez Lopez
Address 55319 0
pza nicaragua, 9, 9 A
Mostoles
28936 Madrid
Country 55319 0
Spain
Phone 55319 0
+34679336394
Fax 55319 0
Email 55319 0
[email protected]
Contact person for scientific queries
Name 55320 0
Elena Sonsoles Rodriguez Lopez
Address 55320 0
pza nicaragua, 9, 9 A
Mostoles
28936 Madrid
Country 55320 0
Spain
Phone 55320 0
+34679336394
Fax 55320 0
Email 55320 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
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