Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000495224
Ethics application status
Approved
Date submitted
21/12/2017
Date registered
5/04/2018
Date last updated
5/11/2019
Date data sharing statement initially provided
6/03/2019
Date results information initially provided
29/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Visceral osteopathy in patients with neck pain and bad digestion with the aim of reducing these troubles.
Scientific title
effects of visceral osteopathy and thoracic manipulation in patients with dyspepsia
Secondary ID [1] 293652 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
functional dyspepsia 305948 0
Condition category
Condition code
Alternative and Complementary Medicine 305142 305142 0 0
Other alternative and complementary medicine
Oral and Gastrointestinal 305143 305143 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 study is divided into two groups. The study is done in a private clinic ( " Clínica Manso " ) once a week for 4 weeks, the duration of each session is one hour and a half.

1. Experimental Group.
· first session: we give the patient the information about the study. He must complete the clinical history, sign the informed consent and perform two scales of quality of life ( Dyspepsia related health scale and Gastrointestinal quality of life scale ).
Then, the baropodometry and algometry in the spinous of the fourth, fifth and sixth thoracic vertebrae and the trigger points of the upper trapezius are performed. After the measurements we do the treatment.
The treatment consists of:
- 20 minutes of TENS currents.
We place 2 electrodes to the patient on both sides of the spine of the seventh cervical vertebra. The TENS current is continuous with a frequency of 100 Hertz. The patient's sensation will be tingling. The purpose of the TENS is to produce analgesia.
- dog technique in the fifth thoracic vertebrae: the patient is in the supine decubitus, he brings his right hand to his left shoulder and his left hand to his right shoulder so that his elbows form a V.
The therapist makes contact with his hand in the patient's fifth thoracic vertebra, his other hand and his abdomen rest on the elbows of the patient.
Finally, a single manipulative impulse is made at the end of the exhalation.
- 2 visceral osteopathy techniques ( stretch of the diaphragm and global hemodynamic abdomen technique )
When the treatment is finished the measurements of baropodometry and algometry are repeated.
· second and third session: we repeat the measurements before and after treatment as well as the treatment already described.
· fourth session: the patient completes " Gastrointestinal quality of life scale) and we makes the baropodometry and algometry. No treatment is done in this session.

The baropodometry is performed on a pressure platform by a podiatrist with more than 10 years of experience.
Algometry is performed with an analog meter by a physiotherapist and osteopath with more than 15 years of experience.
I do the treatment. I'm a physiotherapist and osteopath with 6 years of experience.

2. Control Group: the same procedure is followed.
The measurements are the same but we modify the treatment techniques.
In the vertebral manipulation we don't perform the final push. The techniques of visceral osteopathy are replaced by 10 deep breaths.
Intervention code [1] 299918 0
Treatment: Other
Intervention code [2] 299919 0
Rehabilitation
Comparator / control treatment
the control treatment is placebo because we do the manipulation technique of T5 without the final push and visceral osteopathy techniques are replaced by 10 deep breaths. So the placebo is a sham treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 304295 0
changes at the center of gravity. We measure it in a platform of pressures.
Timepoint [1] 304295 0
In the first session we measure the center of gravity immediately before and immediately after treatment.
We repeat the process:
-after a week of the first session.
-after two weeks of the first session.
-after 3 weeks of the first session (primary endpoint).
Primary outcome [2] 304296 0
pain in the dorsal spines ( T4, T5, T6). We measure it with an algometer.
Timepoint [2] 304296 0
In the first session we measure the pain in the dorsal spines immediately before and immediately after treatment.
we repeat the process:
-after a week of the first session.
-after two weeks of the first session.
-after 3 weeks of the first session (primary endpoint).
Primary outcome [3] 304297 0
pain in trigger points of upper trapezius. We measure it with an algometer.
Timepoint [3] 304297 0
In the first session we measure the pain in trigger points of upper trapezius immediately before and immediately after treatment.
we repeat the process:
-after a week of the first session.
-after two weeks of the first session.
-after 3 weeks of the first session (primary endpoint).
Secondary outcome [1] 341518 0
Gastrointestinal quality of life questionnaire.
Timepoint [1] 341518 0
immediately before of the treatment at the first session.
3 weeks after the first session.
Secondary outcome [2] 343897 0
Dyspepsia Related Health Scale.
Timepoint [2] 343897 0
It is done only in the first session.

Eligibility
Key inclusion criteria
Patients with functional dyspepsia.
patients with neck pain.
patients with index of body mass < 30.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Be pregnant.
have diagnosed medical pathology like hiatal hernia, helicobacter pylori, duodenal ulcers.... any infection, tumor, vascular or neurological involvement.
take medication
abdominal or dorsolumbar surgeries.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2018
Actual
30/04/2018
Date of last participant enrolment
Anticipated
Actual
3/05/2019
Date of last data collection
Anticipated
Actual
24/05/2019
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 9457 0
Spain
State/province [1] 9457 0
Asturias

Funding & Sponsors
Funding source category [1] 298269 0
Self funded/Unfunded
Name [1] 298269 0
Laura Argüelles Movillo
Country [1] 298269 0
Spain
Primary sponsor type
Individual
Name
Laura Argüelles Movillo
Address
Clínica Manso.
c/ ceán Bermúdez 22-24
33208
Gijón, Asturias
Country
Spain
Secondary sponsor category [1] 297388 0
None
Name [1] 297388 0
Address [1] 297388 0
Country [1] 297388 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299271 0
Comité de Ética de la Investigación del Principado de Asturias
Ethics committee address [1] 299271 0
Avda. de Roma, s/n
N-1, S3.19
H.U.C.A
33011 Oviedo
Ethics committee country [1] 299271 0
Spain
Date submitted for ethics approval [1] 299271 0
26/02/2018
Approval date [1] 299271 0
08/03/2018
Ethics approval number [1] 299271 0
82/18

Summary
Brief summary
The main purpose of the study is to determine the effectiveness of visceral osteopathic treatment in patients with functional dyspepsia assessing whether it improves their symptomatology as well as their posture when working directly on the abdomen.
I have chosen this topic because currently the treatments and diagnosis of dyspepsia are expensive and ineffective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79862 0
Miss laura argüelles movillo
Address 79862 0
Clínica Manso
c/ ceán Bermúdez 22-24
33208
Gijón, Asturias
Country 79862 0
Spain
Phone 79862 0
+34 654 71 78 35
Fax 79862 0
Email 79862 0
[email protected]
Contact person for public queries
Name 79863 0
Miss laura argüelles movillo
Address 79863 0
Clínica Manso
c/ ceán bermúdez 22-24
33208
Gijón, Asturias
Country 79863 0
Spain
Phone 79863 0
+34 654717835
Fax 79863 0
Email 79863 0
[email protected]
Contact person for scientific queries
Name 79864 0
Miss laura argüelles movillo
Address 79864 0
Clínica Manso
c/ ceán bermúdez 22-24
33208
Gijón, Asturias
Country 79864 0
Spain
Phone 79864 0
+34 654717835
Fax 79864 0
Email 79864 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
because the results will be show together by comparing the two study groups.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4415Ethical approval    374201-(Uploaded-28-08-2019-02-50-15)-Study-related document.pdf



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.