Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000246785
Ethics application status
Approved
Date submitted
28/02/2013
Date registered
1/03/2013
Date last updated
26/03/2019
Date data sharing statement initially provided
26/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Sacroiliacal dysfunction during pregnancy-correlation between specific test of physiotherapy assessment, pain and mobility
Scientific title
Sacroiliacal dysfunction during pregnancy-correlation between specific test of physiotherapy assessment, pain and mobility
Secondary ID [1] 282037 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sacroiliacal dysfunction during pregnancy 288491 0
Pain and mobility during pregnancy 288492 0
Condition category
Condition code
Physical Medicine / Rehabilitation 288837 288837 0 0
Physiotherapy
Reproductive Health and Childbirth 288838 288838 0 0
Normal pregnancy
Musculoskeletal 288839 288839 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It will be assess sacroiliacal joints using specific physiotherapy tests:
COMPRESSION TEST
The test is perfomed with the patient in side-lying. The examiner stands behind the patient with their elbows locked in extension and palms interlocked over the upper part of the patient's iliac crest and exerts a downward force towards the floor. An increased feeling of pressure in the sacroiliac joints indicates a positive sign for the compression test.
DISTRACTION TEST
The test is performed with the patient in a supine position. The examiner places both hands on the patient's anterior superior iliac spine, pressing downward and laterally. Unilateral gluteal or posterior leg pain indicates a positive test for the distraction test.
FORTIN FINGER TEST
The test is performed with the patient standing, facing away from the examiner. The subject is asked to use one finger to point to the area of pain.The test is considered positive if the patient can pinpoint the pain with one finger, the area pointed to is immediately inferomedial to the posterior superior iliac spine within 1 cm.
POSTERIOR PELVIC PAIN PROVOCATION TEST
The test is performed supine and the patient's hip flexed to an angle of 90 degrees on the side to be examined: light manual pressure is applied to the patient's flexed knee along the longitudinal axisis of the femur while the pelvis is stabilized by the examiner's other hand resting on the patients contralateral superior anterior iliac spine. The test is positive when the patient feels localized pain deep in the gluteal area on the provoked side.
GILLET TEST
The test is performed with the patient standing, facing away from the examiner, with the feet approximately a foot apart. Once each posterior superior iliac spine is localized by the examiner's thumbs, the patient is asked to stand on one leg while bringing the opposite knee up toward the chest. If the sacroilacal joint on the side on which the knee is flexed moves slightly or in a superior direction, the joint is considered hypomobile, which indicates a positive test.
NUMBER RATING SCALE
The scale assesses the severity of pain on a numerical scale from 0 to 10, where 0 means no pain, 1-3 means mild pain (nagging, annoying, interfering little with daily activities), 4–6 means moderate pain (interferes significantly with daily activities) and 7-10 means severe pain (disabling; unable to perform daily activities).
PREGNANCY MOBILTY INDEX
Pregnancy mobility index assesses the degree of disability in activities of daily living in pregnant women. Estimated daily mobility in the house (standing up from a hard chair, standing up from a soft chair, standing up from the bed, getting things from the floor, putting on shoes, turning around in bed, standing up from the floor), household activities (vacuum cleaning, doing laundry, hanging wash to dry, working on the knees, sitting in squatted position, working standing up, lifting 5 kilograms, lifting 10 kilograms, walking stairs) and mobility outdoors (traveling by train, traveling by car, traveling by bicycle, traveling by bus, walking 50 meters, walking 200 meters, walking 500 meters, walking in uneven area). Every item has a score option from 0-3 where 0 means no problems performing this task, 1 means some effort performing this task, 2 means much effort performing this task and 3 means performing this task is impossible or only possible with the aid of others.
All participants will undergo all of these tests. Tests will take a half an hour. Every day we will assess 15 participants every a half an hour over 6 months, at each individual session, supervised one on one with an physiotherapist. Each participants will only come in for a single visit, the test will take half an hour for each participants.
Intervention code [1] 286627 0
Diagnosis / Prognosis
Intervention code [2] 286628 0
Rehabilitation
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288967 0
Correlation of sacroiliacal dysfunction and pain in first, second and third trimester of pregnancy by positive physiotherapy assessment tests and number rating scale
Timepoint [1] 288967 0
At one physiotherapy assessment
Primary outcome [2] 288968 0
Correlation of sacroiliacal dysfunction and mobility in first, second and third trimester of pregnancy by positive physiotherapy assessment tests and pregnancy mobilty index
Timepoint [2] 288968 0
At one physiotherapy assessment
Secondary outcome [1] 301469 0
Detection of sacroiliacal dysfunction in first, second and third trimester of pregnancy by specific physiotherapy assessment tests:compression test, distraction test, fortin finger test, posterior pelvic pain provocation test and Gillet test
Timepoint [1] 301469 0
At one physiotherapy assessment

Eligibility
Key inclusion criteria
Primigravida, gestation age range from 7. to 38.week of pregnancy, without previously symptoms of sacroiliacal dysfunction
Minimum age
25 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Multigravida, gestation age range less than 7. and more than 38.week of pregnancy, with previously symptoms of sacroiliacal dysfunction

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For statistical analyses it will be used calculated the frequency (to determine how much patient have positive specific test of physiotherapy assessment, how much patient have pain and how much patient have limitation of mobility in daily activities),t-test for high paired samples (for determining the presence and/or absence of statistically significant differences) and correlation test (to determine correlation between sacroiliacal dysfunction and pain, and correlation between saroiliacal dysfunction and limitation in mobiliy indaily activities)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
13/06/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment outside Australia
Country [1] 4886 0
Croatia
State/province [1] 4886 0
Zagreb

Funding & Sponsors
Funding source category [1] 286815 0
Hospital
Name [1] 286815 0
Clinical hospital,Sveti Duh,Department of physical medicine, rehabilitation and reumatology
Country [1] 286815 0
Croatia
Primary sponsor type
Hospital
Name
Clinical hospital “Sveti Duh”,Department of physical medicine, rehabilitation and reumatology
Address
Sveti Duh 64
10 000 Zagreb
Country
Croatia
Secondary sponsor category [1] 285604 0
None
Name [1] 285604 0
Address [1] 285604 0
Country [1] 285604 0
Other collaborator category [1] 277306 0
Individual
Name [1] 277306 0
Manuela Filipec
Clinical hospital “Sveti Duh”,Department of physical medicine, rehabilitation and reumatology
Address [1] 277306 0
Sveti Duh 64, 10 000 Zagreb
Country [1] 277306 0
Croatia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288882 0
Ethic Committee of Clinical hospital,Sveti Duh
Ethics committee address [1] 288882 0
Ethics committee country [1] 288882 0
Croatia
Date submitted for ethics approval [1] 288882 0
Approval date [1] 288882 0
21/02/2013
Ethics approval number [1] 288882 0
011-642

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

Contacts
Principal investigator
Name 38198 0
Mrs Manuela Filipec
Address 38198 0
Clinical hospital “Sveti Duh” Department of physical medicine, rehabilitation and reumatology Sveti Duh 64 10 000 Zagreb
Country 38198 0
Croatia
Phone 38198 0
+385917316607
Fax 38198 0
+38513712206
Email 38198 0
[email protected]
Contact person for public queries
Name 38199 0
Manuela Filipec
Address 38199 0
Clinical hospital “Sveti Duh” Department of physical medicine, rehabilitation and reumatology Sveti Duh 64 10 000 Zagreb
Country 38199 0
Croatia
Phone 38199 0
+385917316607
Fax 38199 0
+38513712206
Email 38199 0
[email protected]
Contact person for scientific queries
Name 38200 0
Manuela Filipec
Address 38200 0
Clinical hospital “Sveti Duh” Department of physical medicine, rehabilitation and reumatology Sveti Duh 64 10 000 Zagreb
Country 38200 0
Croatia
Phone 38200 0
+385917316607
Fax 38200 0
+38513712206
Email 38200 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
Data will not be available because of decision of Clinical hospital "Sveti Duh".


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
SourceTitleYear of PublicationDOI
EmbaseIncidence, pain, and mobility assessment of pregnant women with sacroiliac dysfunction.2018https://dx.doi.org/10.1002/ijgo.12560
N.B. These documents automatically identified may not have been verified by the study sponsor.