Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001381875
Ethics application status
Approved
Date submitted
15/01/2021
Date registered
11/10/2021
Date last updated
12/09/2022
Date data sharing statement initially provided
11/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changes in the Autonomous Nervous System and in the cranio-facial pain threshold after applying visceral manual therapy in patients with chronic migraine and functional gastrointestinal disorders.
Scientific title
Changes in the Autonomous Nervous System and in the cranio-facial pain threshold after applying visceral manual therapy in patients with chronic migraine and functional gastrointestinal disorders.
Secondary ID [1] 302464 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary chronic migraine headaches 319294 0
Functional gastrointestinal disorders 319295 0
Condition category
Condition code
Physical Medicine / Rehabilitation 317293 317293 0 0
Physiotherapy
Neurological 320202 320202 0 0
Other neurological disorders
Oral and Gastrointestinal 320203 320203 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
Manual therapy applied by expert physiotherapist with minimum 15 years experience.
Maneuvers aiming to improve the functional status of the diaphragm and gastrointestinal areas will be applied. These maneuvers pretend to mobilize and stretch the diaphragm and gastrointestinal areas, as well as relax them by means of pressure.
Maneuvers are controlled, soft and painless.
Subjects will remain lying down, lying side and seated.
Intervention is applied once during 10 minutes in neuroscience laboratory of the Balearic Island University
Interventors will use a cronometer and a list of the maneuvers to apply a repeatable methodology
Intervention code [1] 318779 0
Rehabilitation
Intervention code [2] 320993 0
Treatment: Other
Comparator / control treatment
Hands will be applied on the skin of subject without applying any pressure or movement
Interventors will be solving mathematical operation consisting of mentally adding 2 by 2 to divert their attention from the intervention
Control group
Active

Outcomes
Primary outcome [1] 325351 0
Time domain and frecuency domain parameters of heart rate variability will be taken using Biopac.
Timepoint [1] 325351 0
Before and immediately after intervention.
Secondary outcome [1] 387596 0
Craneofacial pain using digital algometer.
3 reference points will be measured: occipitomastoid suture, neural supraorbitary point of I branch trigeminal nerve and superior fibers trapezium muscle trigger point.
Timepoint [1] 387596 0
Before and immediately after intervention
Secondary outcome [2] 387597 0
Composite cervical mobility: flexo-extension, lateroflexion and bilateral rotacion mobility with inclinometer.
Timepoint [2] 387597 0
Before and immediately after intervention
Secondary outcome [3] 389455 0
Actual rest pain using VAS scale (visual analogue scale)
Timepoint [3] 389455 0
Before and immediately after intervention
Secondary outcome [4] 389457 0
Blood pressure measured using a sphygmomanometer
Timepoint [4] 389457 0
Before and immediately after intervention
Secondary outcome [5] 390044 0
Somatic sensitivity of I branch trigeminal nerve through Von Frey filaments.
Timepoint [5] 390044 0
Before and inmediately after intervention

Eligibility
Key inclusion criteria
Functional gastrointestinal disorders according Rome IV elegibility criteria.
Chronic migraine
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cervical surgery
Malformations of the cranio-cervical region
Recent fractures or trauma to the cranio-cervical region
Recent tumors and / or metastases.
Pregnancy
Bowel disease with risk of perforation: Chron, diverticulitis or gastroduodenal ulcer
Gastric surgery
Degenerative neurological diseases
Psychiatric illnesses
Hipertensive patients
Manual treatment in the last week
Intake of AINES, Triptans (asociated to acute episode of migraine) or Botolinum toxium last 24 hours
Intake of chronic beta blockers

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)
Allocation concealment will be guaranteed by sequentially numbered, opaque, sealed envelopes. an outside coworker will safeguard the sequence for those participating in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (https://www.randomizer.org)
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
Sample size will be estimated according to the results obtained in the first 10 patients per group, to dispose of data in order to make the statistical assumptions supporting the calculations.
Descriptive statistics will include mean, standard deviations and 95% confidence interval for continuous measures, or percentages for categorical responses.
The two-sample t-test or U Mann Whitney test will be used to examine potential differences in baseline values, demographic variables and outcome measures between the two groups.
The normality of distributions will be assessed according to Shapiro-Wilk or Kolmogorov-Smirnov test, depending on the final sample size.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/04/2021
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
40
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 23053 0
Spain
State/province [1] 23053 0
Balearic Island

Funding & Sponsors
Funding source category [1] 306892 0
University
Name [1] 306892 0
University institute for research in health sciences (IUNICS)
Country [1] 306892 0
Spain
Primary sponsor type
University
Name
University institute for research in health sciences (IUNICS)
Address
Edifici Cientificotècnic.
Campus Universitari.
Universitat de les Illes Balears
Carretera de Valldemossa Km. 7.5
E-07122 Palma de Mallorca
Country
Spain
Secondary sponsor category [1] 307449 0
None
Name [1] 307449 0
Address [1] 307449 0
Country [1] 307449 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307048 0
Research Ethics Committee of the Balearic Islands University
Ethics committee address [1] 307048 0
Universitat de les Illes Balears.
Cra. de Valldemossa, km 7.5. Palma (Illes Balears).
Ethics committee country [1] 307048 0
Spain
Date submitted for ethics approval [1] 307048 0
Approval date [1] 307048 0
25/09/2020
Ethics approval number [1] 307048 0
155CER20

Summary
Brief summary
The objective is to assess the changes produced by manual visceral treatment in a homogeneous group of patients with chronic migraine and functional gastrointestinal disorders.
These changes produced will be measured at the level of the Autonomous Nervous System (heart rate variability), in cervical mobility, sensitive threshold and in the pressure pain threshold on the sutural cranial point, a neural point (Valleix supraorbital neural point ) and a muscular trigger point (upper fibers of the Trapezius muscle) after performing manual visceral techniques on the diaphragm and some gastrointestinal areas.
The hypothesis is that visceral manual maneuvers should have influence on craneofacial pain by modulating the autonomic nervous system
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105842 0
Prof Antonio S. Jaume Llinás
Address 105842 0
Universitat de les Illes Balears. Cra. de Valldemossa, km 7.5. 07122 Palma (Illes Balears).
Country 105842 0
Spain
Phone 105842 0
+0034696487581
Fax 105842 0
Email 105842 0
[email protected]
Contact person for public queries
Name 105843 0
Prof Antonio S. Jaume Llinás
Address 105843 0
Universitat de les Illes Balears. Cra. de Valldemossa, km 7.5. 07122 Palma (Illes Balears).
Country 105843 0
Spain
Phone 105843 0
+0034696487581
Fax 105843 0
Email 105843 0
[email protected]
Contact person for scientific queries
Name 105844 0
Prof Antonio S. Jaume Llinás
Address 105844 0
Universitat de les Illes Balears. Cra. de Valldemossa, km 7.5. 07122 Palma (Illes Balears).
Country 105844 0
Spain
Phone 105844 0
+0034696487581
Fax 105844 0
Email 105844 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
None


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9415Ethical approval  [email protected] 380696-(Uploaded-12-10-2020-16-56-44)-Study-related document.pdf



Results publications and other study-related documents

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Documents added automatically
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