Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000540617
Ethics application status
Approved
Date submitted
28/02/2023
Date registered
22/05/2023
Date last updated
16/11/2023
Date data sharing statement initially provided
22/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of craniofacial manual therapy on the masseter muscle morphology and postural stability in healthy adults
Scientific title
Effects of craniofacial manual therapy on the masseter muscle morphology and elasticity in healthy population
Secondary ID [1] 291692 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
healthy volunteers - effects of craniofacial manual therapy on the masseter muscle morphology, thickness, elasticity for treatment temporal-mandibular disorders 329174 0
Condition category
Condition code
Physical Medicine / Rehabilitation 326146 326146 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in each group (arm 1, 2 an 3) will deliver face to face intervention in 3 sets of 10 minutes manual therapy technics in 7 days interval (10 minutes session once a week for a 3 weeks). Each session will be performed by the same physiotherapist (early stage physiotherapist who passed some courses in craniofacial therapy). Interventions will occur at Musculoskeletal Elastography and Ultrasonography Laboratory, Institute of Physiotherapy and Health Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice. POLAND.

Arm 1 - Extraoral Therapy
- 30 finger movements along the fibers of the masseter muscle from the outside – along the belly of the masseter muscle from the zygomatic arch to the angle and lateral surface of ramus of mandible.
- 15 finger movements along the zygomatic arch (from nose to lateral)
- 15 finger movements along the fibers of musculus temporalis
- 15 finger movements along the ramus of mandible- submandibular region

Arm 2 - Intraoral Therapy
- 30 finger movements along the fibers of the masseter muscle from the inside- The therapist's thumb inside the patient's mouth, the rest of the fingers on the outside of the cheek. Therapist in disposable gloves.
- 15 seconds pressure of the Lateral Pterygoid muscle at 4 different angles (15 seconds each)- the index finger upward and backward past the upper last mollar x 2

Arm 3 - Extraoral and intraoral Therapy
- 15 finger movements along the fibers of the masseter muscle from the outside – along the belly of the masseter muscle from the zygomatic arch to the angle and lateral surface of ramus of mandible.
- 15 finger movements along the zygomatic arch (from nose to lateral)
- 15 finger movements along the fibers of musculus temporalis
- 15 finger movements along the ramus of mandible- submandibular region
- 15 finger movements along the fibers of the masseter muscle from the inside- The therapist's thumb inside the patient's mouth, the rest of the fingers on the outside of the cheek. Therapist in disposable gloves.
- 15 seconds pressure of the Lateral Pterygoid muscle at 4 different angles (10 seconds each)- the index finger upward and backward past the upper last mollar
Intervention code [1] 325545 0
Rehabilitation
Intervention code [2] 325948 0
Treatment: Other
Comparator / control treatment
Extraoral group - ARM 1
Control group
Active

Outcomes
Primary outcome [1] 334020 0
Thickness of the masseter muscle [in mm]

Thickness of the masseter muscle will be assessed using USI Aixplorer (Product Version 12.2.0., Software Version 12.2.0.808, Supersonic Imagine, Aix-en-Provence, France), linear-array transducer (2–10 MHz; SuperLinear 10– 2, Vermon, Tours, France)
Timepoint [1] 334020 0
Before each intervention, after each intervention, 24h after each intervention, 7 days after each intervention
Primary outcome [2] 334021 0
Elasticity of the masseter muscle [in kPa]

Elasticity of the masseter muscle will be assesed using USI Aixplorer (Product Version 12.2.0., Software Version 12.2.0.808, Supersonic Imagine, Aix-en-Provence, France), linear-array transducer (2–10 MHz; SuperLinear 10– 2, Vermon, Tours, France)
Timepoint [2] 334021 0
Before each intervention, after each intervention, 24h after each intervention, 7 days after each intervention
Secondary outcome [1] 419109 0
Dynamic stability test Y-Balance Test [cm, asymmetry]


The device consists of a single central plastic plate and three attached tubes arranged in anterior, posteromedial and posterolateral positions. A measure is positioned on each of the tubes, with an interval of 0.5 cm. The subjects, while standing on one leg (barefoot) in a central location on the Y-Balance Test instrument, with hands placed on the wing of ilium, will be ask to move the pointer as far as possible, using the lower limb opposite to the support limb, in three directions e anterior, posteromedial, posterolateral.” - „Reliability and number of trials of Y Balance Test in adolescent athletes” P.Linek et. al. 2017
Timepoint [1] 419109 0
Before first intervention, after last intervention
Secondary outcome [2] 419110 0
2. Romberg’s test on the Platform Human Balance [percent,cm,cm/s]

For evaluation of dynamic stabilization: Stability score (%), path leght (cm), average velocity (cm/s)
„the patient is asked to remove shoes and stand with both feet together on the platform. Next, the examiner instructs the patient to hold his/her arms next to the body or crossed in front of the body. The first stage of the test involves asking the patient to keep their eyes open while the examiner assesses the patient's body movement relative to balance.
The second stage involves instructing the patient to stand erect with their eyes closed while the examiner notes any balance impairment for a duration of one minute. Swaying of the body may be observed. However, this indicates the proprioceptive correction of balance for the lack of visual or vestibular compensation available. The Rhomberg test is positive when the patient has a loss of balance with their eyes closed. Loss of balance can be defined as increased body swaying, foot movement in the direction of the fall, or falling
Timepoint [2] 419110 0
Before first intervention, after last intervention
Secondary outcome [3] 419111 0
Tekscan Strideway [cm, m/s, kg]

For evaluation of human gait and postural stability.
Step length - (cm), gait velocity - (m/s), Force - (kg) will be assesed.


The provided software automatically reads from the physical sensors in the mat and performs calculations to derive different gait parameters such as step length - (cm), gait velocity - (m/s), Force - (kg)

All components will be assessed as a composite secondary outcome
Timepoint [3] 419111 0
Before first intervention, after last intervention

Eligibility
Key inclusion criteria
- People representing the general healthy population
- Ages of 18 and 40
- Consent to participate in research
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-people with local or general contraindications to any manual therapy within craniofacial (external and internal oral)
- Lack of full dentition;
- People undergoing orthodontic treatment;
- pregnancy;
- Individuals with dysfunctions in the stomatognathic system

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)
Randomisation by drawing lots from a container
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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/05/2023
Actual
1/09/2023
Date of last participant enrolment
Anticipated
12/06/2023
Actual
12/09/2023
Date of last data collection
Anticipated
10/10/2023
Actual
13/10/2023
Sample size
Target
15
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 25291 0
Poland
State/province [1] 25291 0
Silesian

Funding & Sponsors
Funding source category [1] 296189 0
University
Name [1] 296189 0
The Jerzy Kukuczka Academy of Physical Education in Katowice
Country [1] 296189 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education in Katowice
Address
40-065 Katowice, Mikolowska 72A
Country
Poland
Secondary sponsor category [1] 315044 0
None
Name [1] 315044 0
Address [1] 315044 0
Country [1] 315044 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297432 0
The Jerzy Kukuczka Academy of Physical Education in Katowice
Ethics committee address [1] 297432 0
Ethics committee country [1] 297432 0
Poland
Date submitted for ethics approval [1] 297432 0
10/10/2022
Approval date [1] 297432 0
17/11/2022
Ethics approval number [1] 297432 0
1/2022 (17.11.2022)

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

Contacts
Principal investigator
Name 74018 0
Miss Natalia Grygierczyk
Address 74018 0
The Jerzy Kukuczka Academy of Physical Education, Katowice, Silesia, Poland
Mikolowska street 72A, Katowice 40-065
Country 74018 0
Poland
Phone 74018 0
+48694888786
Fax 74018 0
Email 74018 0
[email protected]
Contact person for public queries
Name 74019 0
Natalia Grygierczyk
Address 74019 0
The Jerzy Kukuczka Academy of Physical Education, Katowice, Silesia, Poland
Mikolowska street 72A, Katowice 40-065
Country 74019 0
Poland
Phone 74019 0
+48694888786
Fax 74019 0
Email 74019 0
[email protected]
Contact person for scientific queries
Name 74020 0
Pawel Linek
Address 74020 0
The Jerzy Kukuczka Academy of Physical Education, Katowice, Silesia, Poland
Mikolowska street 72A, Katowice 40-065
Country 74020 0
Poland
Phone 74020 0
+48 661768601
Fax 74020 0
Email 74020 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access the attached data to the article.
Available for what types of analyses?
No restrictions
How or where can data be obtained?
Data can be attached with the articles published as a separate file.


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.