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Trial registered on ANZCTR


Registration number
ACTRN12617001493336
Ethics application status
Approved
Date submitted
14/08/2017
Date registered
23/10/2017
Date last updated
28/02/2020
Date data sharing statement initially provided
1/11/2019
Date results information initially provided
1/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of external soft tissue manipulation on bioelectrical activity of the pelvic floor muscles in continent and incontinent women with and without lumbopelvic assymetry.
Scientific title
Evaluation of bioelectrical activity of pelvic floor muscle using external soft tissue manipulation in continent and incontinent women with and without musculoskeletal imbalance of lumbopelvic region.
Secondary ID [1] 292647 0
None
Universal Trial Number (UTN)
U1111-1200-6687
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal imbalance in the lumbopelvic region. 304380 0
Condition category
Condition code
Musculoskeletal 303707 303707 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 303708 303708 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:
1. An interview
2. Instruction of the measurement and testing procedures
3. Signing the constent for participant
4. Examination of pelvis orientation on sagittal, frontal and horizontal plane
5. Electromyographic examination of pelvic floor muscles strength (5 second maximal contractions with 5 second release), endurance (30 second maximal contractions) and rest (60 second release) by means of intravaginal electrode
6. The measurement of the pressure pain threshold with the use of an algometer on erector spinae muscles, diaphragm, sacrotuberus ligament
7. Soft tissue manipulation techniques:
A. Technique one:
Patient: supine lying with the knees flexed and feet resting flat on the table
Therapist: stands behind patients head and do longitudinal strokes with the thumb over rectus abdominis muscle, from a cranial to caudal direction for 90 seconds. The degree of pressure should be sufficient to maintain pain at a level of between 5 and 7- where 10 is the maximum that can be tolerated and reported by the patient.
B. Technique two:
Patient: supine lying with the knees flexed and feet resting flat on the table
Therapist: stands at the level of the abdomen contralateral to the side being treated. A combination of thumbs of both hands gently insinuate contact beneath the lower border of the rib cage, directed cephalad and laterally, until barrier is noted and applies compression for 90 seconds. The degree of pressure should be sufficient to maintain pain at a level of between 5 and 7- where 10 is the maximum that can be tolerated and reported by the patient.
C. Technique three:
Patient: first right, then left side lying with 45 degree flexion in hips and knees
Therapist: sits from the patients back, localizes the ischiorectal fossa and applies compression for 90 seconds. The degree of pressure should be sufficient to maintain pain at a level of between 5 and 7- where 10 is the maximum that can be tolerated and reported by the patient.
D. Technique four:
Patient: prone lying
Therapist: stands behind patients legs with both thumbs on the sacrotuberous ligament and applies compression for 90 seconds. The degree of pressure should be sufficient to maintain pain at a level of between 5 and 7- where 10 is the maximum that can be tolerated and reported by the patient.
8. After soft tissue manipulation techniques:
a. Examination of pelvis orientation on sagittal, frontal and horizontal plane
b. Electromyographic examination of pelvic floor muscles strength (5 second maximal contractions with 5 second release), endurance (30 second maximal contractions) and rest (60 second release) by means of intravaginal electrode
c. The measurement of the pressure pain threshold with the use of an algometer on erector spinae muscles, diaphragm, sacrotuberus ligament


All of the techniques described are performed at each session (30 minutes) by physical therapist with three year experience in physcial therapy of pelvic floor dysfunction. Each participant receives one sessions (four techniques).
Intervention code [1] 298878 0
Rehabilitation
Intervention code [2] 298941 0
Treatment: Other
Comparator / control treatment
The same sof tissue manipulation techniques but without compression.

Control group
Placebo

Outcomes
Primary outcome [1] 303073 0
The electromyographic examination of pelvic floor muscles by means of intravaginal electrode.
Timepoint [1] 303073 0
Baseline and immediately after soft tissue manipulation.
Primary outcome [2] 303074 0
The measurement of the pressure pain threshold with the use of an algometer
Timepoint [2] 303074 0
Baseline and immediately after soft tissue manipulation.
Secondary outcome [1] 337826 0
The examination of pelvic orientation by means of the digital inclinometer.
Timepoint [1] 337826 0
Baseline and immediately after soft tissue manipulation.

Eligibility
Key inclusion criteria
1. Written informed consent
2. Nulliparous women
3. Aged 18-35
4. Overall well- being on the day of examination
5. No contraindications for the sEMG measurements
Minimum age
18 Years
Maximum age
75 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age over 75
2. Gynecological surgeries
3. Surgeries in the abdomen, pelvis, lower extremities in the last of 10 years
4. Injuries of the lower extermities, pelvis or spine on the examination day
5. Contraindications for the measurements: infection, menstruation, allergies to nickel

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)
Central randomisation by http://www.randomization.com
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


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9144 0
Poland
State/province [1] 9144 0

Funding & Sponsors
Funding source category [1] 297276 0
University
Name [1] 297276 0
Opole Medical School
Address [1] 297276 0
Department of Physiotherapy
Katowicka 68
45-060 Opole, Poland
Country [1] 297276 0
Poland
Primary sponsor type
University
Name
Opole Medical School, Department of Physiotherapy
Address
Opole Medical School
Department of Physiotherapy
Katowicka 68
45-060 Opole, Poland
Country
Poland
Secondary sponsor category [1] 296252 0
None
Name [1] 296252 0
Address [1] 296252 0
Country [1] 296252 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298393 0
Opole Medical School's Ethics Committee
Ethics committee address [1] 298393 0
Katowicka 68 Street, 45-060 Opole, Poland
Ethics committee country [1] 298393 0
Poland
Date submitted for ethics approval [1] 298393 0
Approval date [1] 298393 0
26/06/2017
Ethics approval number [1] 298393 0

Summary
Brief summary
The main scientific aim of the project is an objective evaluation of the influence of external soft tissue manipulation on bioelectrical activity of the pevic floor muscles. In physiotherapeutic practice, special attention is being given to the reciprocal anatomical, physiological and biomechanical relationship of the pelvis and the structures connected to it. The lack information about musculoskeletal imbalance on the lumbopelvic region and its influence on pelvic floor muscle function led the authors to conduct this study. The target population in this study will be nulliparous women with lumbopelvic region imbalance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76934 0
Miss Martyna Kasper
Address 76934 0
Opole Medical School
Department of Physiotherapy
Katowicka 68
45-060 Opole
Country 76934 0
Poland
Phone 76934 0
+48 77 441 08 82
Fax 76934 0
Email 76934 0
kasperm@wsm.opole.pl
Contact person for public queries
Name 76935 0
Miss Martyna Kasper
Address 76935 0
Opole Medical School
Department of Physiotherapy
Katowicka 68
45-060 Opole
Country 76935 0
Poland
Phone 76935 0
+48 77 441 08 82
Fax 76935 0
Email 76935 0
kasperm@wsm.opole.pl
Contact person for scientific queries
Name 76936 0
Dr Tomasz Halski
Address 76936 0
Opole Medical School
Department of Physiotherapy
Katowicka 68
45-060 Opole
Country 76936 0
Poland
Phone 76936 0
+48 77 441 08 82
Fax 76936 0
Email 76936 0
rektorat@wsm.opole.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary