Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000766617
Ethics application status
Approved
Date submitted
7/05/2023
Date registered
13/07/2023
Date last updated
16/11/2023
Date data sharing statement initially provided
13/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a single therapy of the temporomandibular joints on the pelvic floor muscles
Scientific title
Evaluation of a single therapy of the temporomandibular joints on the pelvic floor muscles activity, plantar pressure distribution and body balance in healthy women aged 20-30 years
Secondary ID [1] 309416 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urinary incontinence 329774 0
temporomandibular joints dysfunction 329775 0
pelvic floor muscles tone disorder 329776 0
Condition category
Condition code
Musculoskeletal 326675 326675 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 326676 326676 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the experimental group, a one-time therapy of the temporomandibular joints will be used. The therapy will consist of soft tissue mobilization techniques inside and outside the temporomandibular joints. External techniques will include 1-minute compression on the trigger points, positional release and myofascial release within the temporal muscle and masseter muscle. Internal techniques will include coppression and relaxation of the pterygoid muscle and masseter muscle. The therapy will be performed by physiotherapist in the supine position of patient and will last approximately 15 minutes. The measurements will be performed before and after the therapy.
Intervention code [1] 325928 0
Rehabilitation
Comparator / control treatment
The second group will be the no-intervention control group. In this group, the measurements will be carried out also twice with a 15-minute break between measurements, without the intervention applied. During the 15-minute break, patients will be laying in the supine position.
Control group
Active

Outcomes
Primary outcome [1] 334672 0
Evaluation of the bioelectrical activity at rest and during volitional contractions of the pelvic floor muscles, using surface electromyography. Evaluation of the following muscles will be performed: pelvic floor muscles, masseter muscles, sternocleidomastoid muscles, trapezius dorsi descending and ascending parts. The results will be analyzed together, indicating muscle activity and the relationships between them.
Timepoint [1] 334672 0
In the experimental group: Baseline and after a 15-minute therapy of the temporomandibular joints.
In the control group: double measurement with a 15-minute break between measurements, without intervention.
Primary outcome [2] 334673 0
Pelvic floor muscle activity using transabdominal ultrasonography (USG).
Timepoint [2] 334673 0
In the experimental group: Baseline and after a 15-minute therapy of the temporomandibular joints.
In the control group: double measurement with a 15-minute break between measurements, without intervention.
Primary outcome [3] 334674 0
The composite outcome includingbody balance and load distribution using baropodometry platform during standing.
Timepoint [3] 334674 0
In the experimental group: Baseline and after a 15-minute therapy of the temporomandibular joints.
In the control group: double measurement with a 15-minute break between measurements, without intervention.
Secondary outcome [1] 421626 0
Assessment of the mobility of the cervical spine using a centimeter tape.
Timepoint [1] 421626 0
In the experimental group: Baseline and after a 15-minute therapy of the temporomandibular joints.
In the control group: double measurement with a 15-minute break between measurements, without intervention.
Secondary outcome [2] 421627 0
Assessment of the mobility of the temporomandibular joints using a caliper.
Timepoint [2] 421627 0
In the experimental group: Baseline and after a 15-minute therapy of the temporomandibular joints.
In the control group: double measurement with a 15-minute break between measurements, without intervention.

Eligibility
Key inclusion criteria
- nulliparous;
- no pregnancies or miscarriages;
- no reported dysfunctions in the genitourinary system;
- consent to participate in the study
Minimum age
20 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- dysfunction in the genitourinary system;
- past surgical procedures;
- trauma in the last 6 months before entering the study;
- neurological diseases;
- systemic diseases;
- pregnancy;
- participation in therapy within the temporomandibular joints in the last 6 months before entering the study;
- pelvic floor muscle training in the last 6 months before entering the study;
- lack of consent to participate in research

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using sequentially numbered opaque and sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by flipping a coin
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
Statistical analysis will be performed using the STATISTICA 12.0 Pl software. The Shapiro–Wilk test will be conducted to assess data for normality. To determine the significance of differences analysis of variance will be performed. Post-hoc analysis will performed using the post-hoc test. Using the paired t-test for power analysis of exercise, it was determined that at least 17 subjects from each group were required to obtain a power of 0.8 at a two-sided level of 0.05 with the effect size of d = 0.8.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/07/2023
Actual
22/09/2023
Date of last participant enrolment
Anticipated
31/07/2023
Actual
27/10/2023
Date of last data collection
Anticipated
30/09/2023
Actual
9/11/2023
Sample size
Target
60
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 25434 0
Poland
State/province [1] 25434 0

Funding & Sponsors
Funding source category [1] 313610 0
Government body
Name [1] 313610 0
programme of the Minister of Science and Higher Education under the name “Regional Initiative for Perfection”
Country [1] 313610 0
Poland
Primary sponsor type
Individual
Name
PhD Iwona Sulowska-Daszyk
Address
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 315403 0
None
Name [1] 315403 0
Address [1] 315403 0
Country [1] 315403 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312785 0
Bioethics Committee of Andrzej Frycz Modrzewski Krakow University
Ethics committee address [1] 312785 0
Ethics committee country [1] 312785 0
Poland
Date submitted for ethics approval [1] 312785 0
05/04/2023
Approval date [1] 312785 0
21/09/2023
Ethics approval number [1] 312785 0
KBKA/50/O/2023

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

Contacts
Principal investigator
Name 125910 0
Dr Iwona Sulowska-Daszyk
Address 125910 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 125910 0
Poland
Phone 125910 0
+48126831134
Fax 125910 0
Email 125910 0
[email protected]
Contact person for public queries
Name 125911 0
Iwona Sulowska-Daszyk
Address 125911 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 125911 0
Poland
Phone 125911 0
+48126831134
Fax 125911 0
Email 125911 0
[email protected]
Contact person for scientific queries
Name 125912 0
Iwona Sulowska-Daszyk
Address 125912 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 125912 0
Poland
Phone 125912 0
+48126831134
Fax 125912 0
Email 125912 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
Results will be analysed at the experimental and control groups data level, and any results from this trial that are published in scientific journals will publish group data only.


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.