Breathing ExercisesECOPORTANCT03516344
Effect of Osteopathic Manipulations on Portal Venous Flow
A study testing Liver pumping and Spinal manipulation in people with Breathing Exercises and Manipulation, Osteopathic, run by Universidad Antonio de Nebrija at 1 site in Spain.
Trial summary
Since osteopathy it is considered that the alterations in the mobility of the different structures of the organism could cause a decrease in the blood circulation of the tissue causing a functional disorder and, with time, the appearance of a disease. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breathing Exercises, Manipulation, Osteopathic, Physical Therapy
- What is being tested?
- Liver pumping and Spinal manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2018to 30 Sep 2018
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women
- No history of abdominal surgery or liver disease
Who cannot join
- Fear or apprehension of techniques
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Osteopathic Manipulations on Portal Venous Flow: Randomized Clinical Trial
Since osteopathy it is considered that the alterations in the mobility of the different structures of the organism could cause a decrease in the blood circulation of the tissue causing a functional disorder and, with time, the appearance of a disease.
In visceral osteopathy, the treatment of liver dysfunctions it is important due to their interrelation with the functioning of the rest of the abdominal and pelvic viscera and, especially, through the hepatic portal system. However, there are few studies showing whether a manual therapeutic intervention can affect the mobility, function or vascularization of a viscera.
Read more
Ultrasonography is an appropriate tool for validating some of these intervention procedures given their safety, repeatability, autonomy and the low cost of the procedures and technical equipment which, in a non-invasive manner, will allow the effects of the different therapeutic interventions to be verified.
Hypothesis:
- Vertebral manipulations and pumping of the liver improve the flow of the portal vein in front of the diaphragmatic breathing and the contraction of the psoas iliac muscle.
- The accuracy of ultrasound to assess venous flow may be useful as an outcome measure.
Objectives: To describe the immediate changes of different manipulative interventions on portal vein flow in healthy women and to obtain baseline measurements for future research.
Sample description: Pilot randomized controlled clinical trial with a sample of 50 healthy adult women recruited intentionally sampled that will be pseudo-randomly forcing equality of groups: control, chest manipulation, liver manipulation, abdominal breathing and iliac psoas muscle contraction.
The minimum size required has been calculated using the program G*Power 3.1.3 for Windows (University Kiel, Germany, 2008) based on an effect size of 0.5, type I error of 5%,type II error of 10% and an effect size of f=0.45.
Read the detailed description
The non-invasive intervention procedure in each of the groups is as follows:
- Control group (CG): Subjects will remain at rest in supine position for one minute.
- Thoracic manipulation group (GMT): A semi-direct vertebral manipulation will be performed, type Dog Technique in extension, above level D8.
- Liver manipulation group (HMG): A supine hepatic pumping technique will be performed, performing simultaneous compression in the right hypochondrium and epigastrium, in the opposite direction, during the inspiratory phase, stopping during the expiratory phase and repeating the maneuver for five respiratory cycles.
- Abdominal breathing group (GRA): Subjects will be asked to perform five cycles of diaphragmatic breathing in the supine position.
- Psoas exercise group (GPS): In the supine position with a high density foam cushion under the feet of the subject, it will be asked to make a push in the caudal direction, against the cushion, alternating between both feet with the knees stretched, for one minute.
After informed consent and recording of personal data, participants will be placed in a constant and regulated temperature room where they will be placed in supine position for 5 minutes for cardiocirculatory normalization, at least 2 hours after the last meal. The room where the explorations will be carried out is conditioned to keep the ambient temperature constant.
The study will be carried out with independent recruitment and triple blinding: the patient will not know the intervention group, the sonographer will not know the technique applied to the patients, the researcher responsible for recording the flows and diameters and the temperature will also be masked and the data analyst will be masked during the statistical analysis process.
For statistical analysis, a descriptive analysis using means and standard deviations will be performed, as well as ranges and quartiles for quantitative measurements. Qualitative variables shall be summarised by counts and frequencies. The assumption of normality (Shapiro-Wilks test) and equality of variances (Levene's test) prior to the analysis of variance (ANOVA) will be checked for repeated measurements in which the intra-unit factors (three time measurements) will be the dependent variables (velocity, diameter and temperature) and the inter-subject factor, the study group. If it is not possible to assume the application assumptions, the corresponding non-parametric tests will be chosen. Pair comparisons were made with the Dunn-Bonferroni correction for type I erro and the age and BMI variables were entered into the model as covariates to estimate their possible effect on the dependent variables. The percentages of change from the baseline values in the intra-group comparison and from the control group in the intergroup comparison shall be calculated. The effect size will be estimated with the Hedges g statistic.
The significance level will be set to p<0.05 and calculations will be performed with SPSS 19.0
- Conditions
- Breathing Exercises, Manipulation, Osteopathic, Physical Therapy, Ultrasonography, Portal Vein
- Being tested
- Liver pumping and Spinal manipulation
- Keywords
- Breathing Exercises, Manipulation, Osteopathic, Quantitative Ultrasonography, Therapy, Soft Tissue, Portal Vein, Venous flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver pumping and Spinal manipulationProcedure or surgery
Also called Vertebral manipulation, Soft tissues mobilization
Interventions are described in group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects will remain at rest in supine position for one minute. |
| Iliac psoas muscle | Experimental | In supine position with a high-density foam cushion under the subject's feet, they will be asked to make a push in the caudal direction, against the cushion, alternating between both feet with their knees stretched out, for one minute Receives: Procedure: Liver pumping and Spinal manipulation |
| Diaphragmatic Breathing | Experimental | Subjects perform five cycles of diaphragmatic breathing in the supine position. Receives: Procedure: Liver pumping and Spinal manipulation |
| Liver pumping | Experimental | A technique of hepatic supine pumping is performed by simultaneous compression in the right hypochondrium and epigastrium, in the opposite direction, during the inspiratory phase, stopping during the expiratory phase and repeating the maneuver for five respiratory cycles. Receives: Procedure: Liver pumping and Spinal manipulation |
| Spinal manipulation | Experimental | A semi-direct vertebral manipulation, type Dog Technique in extension, will be performed on level D8 Receives: Procedure: Liver pumping and Spinal manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow velocity of the portal vein
In cm/s, FV is obtained from ultrasound scans (General Electric LogiqE ultrasound scanner model with the 4C-RS convex probe with a working frequency of 2-5 MHz.).
All image optimization parameters remained constant for all patients and scans. The records will be made by a researcher with 15 years of ultrasound experience.
Measured: Pre-intervention, immediately post-intervention and 5-minutes-post-intervention
Diameter of the portal vein
In mm, DIA is obtained from ultrasound scans (General Electric LogiqE ultrasound scanner model with the 4C-RS convex probe with a working frequency of 2-5 MHz.).
All image optimization parameters remained constant for all patients and scans. The records will be made by a researcher with 15 years of ultrasound experience.
Measured: Pre-intervention, immediately post-intervention and 5-minutes-post-intervention
Secondary outcomes (1)
Temperature of D7-D8 dermatome
The temperature of the dermatome D7-D8, in relation metameric to the liver, is recorded at the xiphoid process level with an infrared thermometer (ºC)
Measured: Pre-intervention, immediately post-intervention and 5-minutes-post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start1 Aug 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breathing ExercisesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Antonio de Nebrija
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Ríos-Díaz, Universidad Antonio de Nebrija
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516344
- Sponsor's protocol ID
- Eco_Porta
- Acronym
- ECOPORTA
- Status last verified
- Oct 2018
- First submitted
- 23 Mar 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Allan PL, Ph.D WNM, Pozniak MA, Dubbins PA. Ecografía doppler clínica. Elsevier España; 2008.
Allan PLP, Baxter GM, Weston M. Clinical Ultrasound. 3rd ed. Philadelphia: Churchill Livingstone Elsevier, 2011
Baert AL, Brady LW, Heilmann HP, Molls M, Sartor K. Duplex and color doppler imaging of the venous system. Springer; 2014.
Harris W, Wagnon RJ. The effects of chiropractic adjustments on distal skin temperature. J Manipulative Physiol Ther. 1987 Apr;10(2):57-60.
PubMed 3585197Hebgen E. Osteopatía Visceral. Fundamentos y técnicas. 2ª edición ed. Madrid: McGraw-Hill. Interamericana; 2005
Korr IM. Bases fisiologicas de la osteopatía. 1ª ed.: Mandala; 2004
Martínez-Payá JJ, de-Groot-Ferrando A, Ríos-Díaz J, del-Baño-Aledo ME. Sonoanatomy of the musculoskeletal system. En: Valera F, Minaya F, editores. Advanced Techniques in Musculoskeletal Medicine & Physiotherapy. Edinburgh: Churchill Livingstone; 2016. p.147-70.
Resende C, Lessa A, Goldenberg RCS. Ultrasonic Imaging in Liver Disease: From Bench to Bedside. Rijeka, Croatia: INTECH Open Access Publisher; 2011.p.127-56.
Ricard F. Tratado de osteopatía visceral y medicina interna. Tomo 2: Sistema digestivo. 1ª edición ed. Madrid: Editorial Médica Panamericana; 2008
Welch A, Boone R. Sympathetic and parasympathetic responses to specific diversified adjustments to chiropractic vertebral subluxations of the cervical and thoracic spine. J Chiropr Med. 2008 Sep;7(3):86-93. doi: 10.1016/j.jcm.2008.04.001.
PubMed 19646369
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Osteopathic Manipulations on Portal Venous Flow: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03516344
- Acronym / sponsor ID
- ECOPORTA / Eco_Porta
- Conditions
- Breathing Exercises, Manipulation, Osteopathic, Physical Therapy, Ultrasonography, Portal Vein
- Keywords
- Breathing Exercises, Manipulation, Osteopathic, Quantitative Ultrasonography, Therapy, Soft Tissue, Portal Vein, Venous flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Antonio de NebrijaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 4 May 2018 (actual)
- 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.
Since osteopathy it is considered that the alterations in the mobility of the different structures of the organism could cause a decrease in the blood circulation of the tissue causing a functional disorder and, with time, the appearance of a disease.
In visceral osteopathy, the treatment of liver dysfunctions it is important due to their interrelation with the functioning of the rest of the abdominal and pelvic viscera and, especially, through the hepatic portal system. However, there are few studies showing whether a manual therapeutic intervention can affect the mobility, function or vascularization of a viscera.
Ultrasonography is an appropriate tool for validating some of these intervention procedures given their safety, repeatability, autonomy and the low cost of the procedures and technical equipment which, in a non-invasive manner, will allow the effects of the different therapeutic interventions to be verified.
Hypothesis:
- Vertebral manipulations and pumping of the liver improve the flow of the portal vein in front of the diaphragmatic breathing and the contraction of the psoas iliac muscle.
- The accuracy of ultrasound to assess venous flow may be useful as an outcome measure.
Objectives: To describe the immediate changes of different manipulative interventions on portal vein flow in healthy women and to obtain baseline measurements for future research.
Sample description: Pilot randomized controlled clinical trial with a sample of 50 healthy adult women recruited intentionally sampled that will be pseudo-randomly forcing equality of groups: control, chest manipulation, liver manipulation, abdominal breathing and iliac psoas muscle contraction.
The minimum size required has been calculated using the program G*Power 3.1.3 for Windows (University Kiel, Germany, 2008) based on an effect size of 0.5, type I error of 5%,type II error of 10% and an effect size of f=0.45.
Detailed description
The non-invasive intervention procedure in each of the groups is as follows:
- Control group (CG): Subjects will remain at rest in supine position for one minute.
- Thoracic manipulation group (GMT): A semi-direct vertebral manipulation will be performed, type Dog Technique in extension, above level D8.
- Liver manipulation group (HMG): A supine hepatic pumping technique will be performed, performing simultaneous compression in the right hypochondrium and epigastrium, in the opposite direction, during the inspiratory phase, stopping during the expiratory phase and repeating the maneuver for five respiratory cycles.
- Abdominal breathing group (GRA): Subjects will be asked to perform five cycles of diaphragmatic breathing in the supine position.
- Psoas exercise group (GPS): In the supine position with a high density foam cushion under the feet of the subject, it will be asked to make a push in the caudal direction, against the cushion, alternating between both feet with the knees stretched, for one minute.
After informed consent and recording of personal data, participants will be placed in a constant and regulated temperature room where they will be placed in supine position for 5 minutes for cardiocirculatory normalization, at least 2 hours after the last meal. The room where the explorations will be carried out is conditioned to keep the ambient temperature constant.
The study will be carried out with independent recruitment and triple blinding: the patient will not know the intervention group, the sonographer will not know the technique applied to the patients, the researcher responsible for recording the flows and diameters and the temperature will also be masked and the data analyst will be masked during the statistical analysis process.
For statistical analysis, a descriptive analysis using means and standard deviations will be performed, as well as ranges and quartiles for quantitative measurements. Qualitative variables shall be summarised by counts and frequencies. The assumption of normality (Shapiro-Wilks test) and equality of variances (Levene's test) prior to the analysis of variance (ANOVA) will be checked for repeated measurements in which the intra-unit factors (three time measurements) will be the dependent variables (velocity, diameter and temperature) and the inter-subject factor, the study group. If it is not possible to assume the application assumptions, the corresponding non-parametric tests will be chosen. Pair comparisons were made with the Dunn-Bonferroni correction for type I erro and the age and BMI variables were entered into the model as covariates to estimate their possible effect on the dependent variables. The percentages of change from the baseline values in the intra-group comparison and from the control group in the intergroup comparison shall be calculated. The effect size will be estimated with the Hedges g statistic.
The significance level will be set to p<0.05 and calculations will be performed with SPSS 19.0
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects will remain at rest in supine position for one minute. |
| Iliac psoas muscle | Experimental | Procedure: Liver pumping and Spinal manipulationIn supine position with a high-density foam cushion under the subject's feet, they will be asked to make a push in the caudal direction, against the cushion, alternating between both feet with their knees stretched out, for one minute |
| Diaphragmatic Breathing | Experimental | Procedure: Liver pumping and Spinal manipulationSubjects perform five cycles of diaphragmatic breathing in the supine position. |
| Liver pumping | Experimental | Procedure: Liver pumping and Spinal manipulationA technique of hepatic supine pumping is performed by simultaneous compression in the right hypochondrium and epigastrium, in the opposite direction, during the inspiratory phase, stopping during the expiratory phase and repeating the maneuver for five respiratory cycles. |
| Spinal manipulation | Experimental | Procedure: Liver pumping and Spinal manipulationA semi-direct vertebral manipulation, type Dog Technique in extension, will be performed on level D8 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women
- No history of abdominal surgery or liver disease
Key exclusion criteria (1 listed)
- Fear or apprehension of techniques
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 |
|---|---|---|
| Liver pumping and Spinal manipulationAlso: Vertebral manipulation, Soft tissues mobilizationInterventions are described in group descriptions | Procedure or surgery | Diaphragmatic Breathing, Iliac psoas muscle, Liver pumping, Spinal manipulation |
Primary outcome
Flow velocity of the portal vein
Time frame: Pre-intervention, immediately post-intervention and 5-minutes-post-intervention
In cm/s, FV is obtained from ultrasound scans (General Electric LogiqE ultrasound scanner model with the 4C-RS convex probe with a working frequency of 2-5 MHz.). All image optimization parameters remained constant for all patients and scans. The records will be made by a researcher with 15 years of ultrasound experience.
Diameter of the portal vein
Time frame: Pre-intervention, immediately post-intervention and 5-minutes-post-intervention
In mm, DIA is obtained from ultrasound scans (General Electric LogiqE ultrasound scanner model with the 4C-RS convex probe with a working frequency of 2-5 MHz.). All image optimization parameters remained constant for all patients and scans. The records will be made by a researcher with 15 years of ultrasound experience.
1 secondary outcome
Temperature of D7-D8 dermatome
Time frame: Pre-intervention, immediately post-intervention and 5-minutes-post-intervention
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 10 Oct 2018.
- BackgroundAllan PL, Ph.D WNM, Pozniak MA, Dubbins PA. Ecografía doppler clínica. Elsevier España; 2008.
- BackgroundAllan PLP, Baxter GM, Weston M. Clinical Ultrasound. 3rd ed. Philadelphia: Churchill Livingstone Elsevier, 2011
- BackgroundBaert AL, Brady LW, Heilmann HP, Molls M, Sartor K. Duplex and color doppler imaging of the venous system. Springer; 2014.
- Background: PubMed 3585197Harris W, Wagnon RJ. The effects of chiropractic adjustments on distal skin temperature. J Manipulative Physiol Ther. 1987 Apr;10(2):57-60.
- BackgroundHebgen E. Osteopatía Visceral. Fundamentos y técnicas. 2ª edición ed. Madrid: McGraw-Hill. Interamericana; 2005
- BackgroundKorr IM. Bases fisiologicas de la osteopatía. 1ª ed.: Mandala; 2004
- BackgroundMartínez-Payá JJ, de-Groot-Ferrando A, Ríos-Díaz J, del-Baño-Aledo ME. Sonoanatomy of the musculoskeletal system. En: Valera F, Minaya F, editores. Advanced Techniques in Musculoskeletal Medicine & Physiotherapy. Edinburgh: Churchill Livingstone; 2016. p.147-70.
- BackgroundResende C, Lessa A, Goldenberg RCS. Ultrasonic Imaging in Liver Disease: From Bench to Bedside. Rijeka, Croatia: INTECH Open Access Publisher; 2011.p.127-56.
- BackgroundRicard F. Tratado de osteopatía visceral y medicina interna. Tomo 2: Sistema digestivo. 1ª edición ed. Madrid: Editorial Médica Panamericana; 2008
- Background: PubMed 19646369Welch A, Boone R. Sympathetic and parasympathetic responses to specific diversified adjustments to chiropractic vertebral subluxations of the cervical and thoracic spine. J Chiropr Med. 2008 Sep;7(3):86-93. doi: 10.1016/j.jcm.2008.04.001.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver pumping and Spinal manipulation in people with Breathing Exercises and Manipulation, Osteopathic, run by Universidad Antonio de Nebrija at 1 site in Spain.
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 2 inclusion and 1 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 10 Oct 2018. 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 Spain. 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?
Flow velocity of the portal vein (time frame: Pre-intervention, immediately post-intervention and 5-minutes-post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03516344, which also lists 10 linked publications.
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 10 Oct 2018.