Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612001205820
Ethics application status
Approved
Date submitted
12/11/2012
Date registered
15/11/2012
Date last updated
16/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Incidence and physiotherapy assessment of sacroiliacal dysfunction using various tests in patients with sacroiliacal dysfunction during pregnancy – a cohort study
Scientific title
Incidence and physiotherapy assessment of sacroiliacal dysfunction using various tests in patients with sacroiliacal dysfunction during pregnancy – a cohort study
Secondary ID [1] 281528 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sacroiliacal dysfunction during pregnancy 287791 0
Condition category
Condition code
Physical Medicine / Rehabilitation 288144 288144 0 0
Physiotherapy
Reproductive Health and Childbirth 288157 288157 0 0
Normal pregnancy
Musculoskeletal 288158 288158 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 tests:
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.
PATRICK'S FABER TEST
The patient lies supine: one leg is flexed, abducted and externally rotated so that the heel rests on the opposite knee. The examiner presses gently on the superior aspect of the tested knee joint. If pain is felt in the sacroiliacal joints or in the symphysis the test is considered positive.
SYMPHYSIS PAIN PALPATION TEST
The patient lies supine. The entire front side of the pubic symphysis is palpated gently. If the palpation causes pain that persists more than 5 s after removal of the examiner's hand, it is recorded as pain. If the pain disappears within 5 s it is recorded as tenderness.
LONG DORSAL SACROILIAC LIGAMENT TEST
The patient lies on her side with slight flexion in both hip and knee joints. If the palpation causes pain that persists for more than 5 seconds after removal of the examiner's hand, it is recorded as pain. If the pain disappears within 5 s it is recorded as tenderness.
ACTIVE STRAIGHT LEG RAISE TEST (ASLR test)
The patient lies supine with straight legs and feet 20 cm apart. The test is performed after the instruction „try to raise your legs, one after another, above the couch for 20 cm without bending the knee“. The patient is asked to score any feeling of impairment (on the both sides separately) on a 6-point scale: not difficult at all=0, minimally difficult=1, somewhat difficult=2, fairly difficult=3, very difficult=4, unable to do=5. The scores on both sides are added so that the sum score can range from 0 to 10.
MODIFY TRENDELENBURG’S TEST
The patient stands on one leg and flexes the hip and knee at 90 degrees. If pain is experienced in the symphysis the test is considered positive.
VISUAL ANALOG PAIN SCALE
Visual analog pain scale assesses the severity of pain on a numerical scale from 0 to 10, where 0 means absence of pain and 10 severe pain.
QUEBEC SCALE
Quebec scale assesses the degree of disability in activities of daily living in pregnant women. Estimated twenty daily activities (out of bed, sleeping during the night, turning in bed, driving, standing 20 to 30 minutes, sitting for hours, climbing stairs, short walk (300 to 400m), long walks (a few kilometres), reach items on shelves, throwing the ball, short running (100m), taking food from refrigerator, making beds, wear socks, bending in the tub, moving chairs, opening doors, carrying two bags from the store, lifting and carrying things) on scale from 0 to 5 where 0 means performing activities without difficulty, 1 means performing activities with minimal difficulty, 2 means performing activities with some difficulty, 3 means performing activities with moderate difficulty, 4 means performing activities with greater difficulty and 5 means inability to performing activities.
All participants will undergo all of these tests.Tests will take a half an hour. Every day we will assess 12 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] 286043 0
Diagnosis / Prognosis
Intervention code [2] 286055 0
Rehabilitation
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288345 0
Primary Outcome 1: detection of sacroiliacal dysfunction by specific physiotherapy assessment tests:posterior pelvic pain provocation test, Patrick's Faber test, symphysis pain palpation test, long dorsal sacroiliac ligament test, active stright raise leg test, modified Trendelenburg's test.
Timepoint [1] 288345 0
Timepoint: at one physiotherapy assessment
Primary outcome [2] 288346 0
Primary Outcome 2:incidence of sacroiliacal dysfunction in first, second and third trimester of pregnancy by positive physiotherapy assessment tests(posterior pelvic pain provocation test, Patrick's Faber test, symphysis pain palpation test, long dorsal sacroiliac ligament test, active stright raise leg test, modified Trendelenburg's test)
Timepoint [2] 288346 0
Timepoint: at one physiotherapy assessment
Secondary outcome [1] 299926 0
Secondary Outcome 1: sacroiliacal pain as assessed using a posterior pelvic pain provocation test, Patrick's Faber test, modified Trenedelenburg test, symphysis pain provocation test, long dorsal sacroiliacal ligament test
Timepoint [1] 299926 0
Timepoint: at one physiotherapy assessment
Secondary outcome [2] 299927 0
Secondary Outcome 2: functional status as assessed using the active straight raise leg test
Timepoint [2] 299927 0
Timepoint: at one physiotherapy assessment
Secondary outcome [3] 299928 0
Secondary Outcome 3: sacroiliacal pain as assessed using a Visual analogue pain scale
Timepoint [3] 299928 0
Timepoint: at one physiotherapy assessment
Secondary outcome [4] 299929 0
Secondary Outcome 4: daily activities as assessed using the Quebec scale
Timepoint [4] 299929 0
Timepoint: at one physiotherapy assessment

Eligibility
Key inclusion criteria
Primigravida, gestation age range from 8. to 37.week of pregnancy, without previously symptoms of sacroiliacal dysfunction
Minimum age
30 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Multigravida, gestation age range less than 8. and more than 37.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
Cohort study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1350
Accrual to date
Final
Recruitment outside Australia
Country [1] 4676 0
Croatia
State/province [1] 4676 0

Funding & Sponsors
Funding source category [1] 286311 0
Hospital
Name [1] 286311 0
Clinical hospital,Sveti Duh,Department of physical medicine, rehabilitation and reumatology
Country [1] 286311 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] 285098 0
None
Name [1] 285098 0
Address [1] 285098 0
Country [1] 285098 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288382 0
Ethic Committee of Clinical hospital,Sveti Duh
Ethics committee address [1] 288382 0
Sveti Duh 64, 10 000 Zagreb
Ethics committee country [1] 288382 0
Croatia
Date submitted for ethics approval [1] 288382 0
Approval date [1] 288382 0
30/10/2012
Ethics approval number [1] 288382 0
011-10201

Summary
Brief summary
Introduction: Sacroiliacal dysfunction during pregnancy leads to a reduction in quality and limit the activities of daily living in pregnant women. Causes of development sacroiliacal dysfunction during pregnancy are combination of hormonal, biomechanical, circulatory and physiological changes. The purpose of this research is the ability to detect sacroiliacal dysfunction during pregnancy using specific tests of physiotherapy assessment, detection incidence of sacroiliacal dysfunction during pregnancy and to detect sacroiliacal dysfunction by trimesters of pregnancy. Materials and methods: The sample consisted of an experimental group, 450 pregnant women in each trimester, which means that total number of pregnant women who were included in study was 1350 (N=1350). Over experimental group was conducted cohort study. In study were used following tests: posterior pelvic pain provocation test, Patrick’s-Faber test, modified Trendelenburg test, ASRL test, symphisis pain palpation test, long dorsal sacroiliacal ligament test, visual analog pain scale and QUEBEC scale. Results and discussion: For statistical analyses it will be used calculated the frequency (for determining the incidence of sacroiliacal dysfunction during pregnancy and by trimesters of pregnancy) and t-test for high paired samples (for determining the existence and/or absence of statistically significant differences). Results should indicate the presence and/or absence of sacroiliacal dysfunction during pregnancy, the incidence of sacroiliacal dysfunction by trimesters of pregnancy and possibility of detection sacroiliacal dysfunction using specific tests of physiotherapy assessment. Using Visual analog pain scale and Quebec scale are expected to detect intensity of pain and degree of disability during everyday activities in pregnant women. Conclusion: Application of diagnostic methods (CT, MRI, X-rays, fluorescent injection) during pregnancy is limited and it is necessary to rely on physiotherapy assessment in the diagnosis of sacroiliacal dysfunction. However, detection of sacroiliacal dysfunction during pregnancy is difficult of the lack of objective standards so.”gold standards”. The research results should detect incidence of sacroiliacal dysfunction in pregnancy and by trimesters of pregnancy and indicated that during pregnancy can/can not detect occurrence of sacroiliacal dysfunction using combination of specific physiotherapy assessment tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34941 0
Address 34941 0
Country 34941 0
Phone 34941 0
Fax 34941 0
Email 34941 0
Contact person for public queries
Name 18188 0
Manuela Filipec
Address 18188 0
Clinical hospital “Sveti Duh”
Department of physical medicine, rehabilitation and reumatology
Sveti Duh 64
10 000 Zagreb
Country 18188 0
Croatia
Phone 18188 0
+385917316607
Fax 18188 0
+38513712206
Email 18188 0
[email protected]
Contact person for scientific queries
Name 9116 0
Manuela Filipec
Address 9116 0
Clinical hospital “Sveti Duh”
Department of physical medicine, rehabilitation and reumatology
Sveti Duh 64
10 000 Zagreb
Country 9116 0
Croatia
Phone 9116 0
+385917316607
Fax 9116 0
+38513712206
Email 9116 0
[email protected]

No information has been provided regarding IPD availability


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.