Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001077752
Ethics application status
Approved
Date submitted
19/09/2013
Date registered
26/09/2013
Date last updated
26/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Inter- and Intra-rater Reliability of Ultrasound Imaging of Lumbar Multifidus and Transverse Abdominal Muscles in Subjects with and without Low Back Pain
Scientific title
Inter- and Intra-rater Reliability of Ultrasound Imaging of Lumbar Multifidus and Transverse Abdominal Muscles in Subjects with and without Low Back Pain
Secondary ID [1] 283250 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain 290124 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290507 290507 0 0
Physiotherapy
Musculoskeletal 290539 290539 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
three days
Target follow-up type
Weeks
Description of intervention(s) / exposure
Subjects with low back pain and healthy controls were assessed in three consecutive days: their lumbar multifidus muscle and transverse abdominal muscle thickness were measured by ultrasound at rest and during contraction. During measuring the thickness of transverse abdominal muscle, subjects were in supine position, and the measurements were taken at rest and while draw in their anterior abdominal wall. The measurement of lumbar multifidus muscle was taken while subject were in prone position at rest and while lifting the contralateral arm. The assessment lasted about 10 minutes per subject. Two raters, blinded to each other's measurements, assessed all the subjects on all 3 days
Intervention code [1] 287980 0
Not applicable
Comparator / control treatment
control healthy group was assessed a the exactly same way as subjects with low back pain (as described in Description of intervention/exposure)
Control group
Active

Outcomes
Primary outcome [1] 290527 0
lumbar multifidus muscle and transverse abdominal muscle thickness measured by ultrasound caliper at rest and during muscle contraction
Timepoint [1] 290527 0
three concecutive days
Primary outcome [2] 290564 0
Intraclass correlation coefficient ICC2,1
Timepoint [2] 290564 0
three days
Secondary outcome [1] 304734 0
nil
Timepoint [1] 304734 0
nil

Eligibility
Key inclusion criteria
subjects with low back pain: low back pain that lasted at least 3 months, self reported pain level 4 or more on Pain Numeric Rating Scale
control subjects: no low back pain for at least one year, no low back surgery, no neurological condition with muscle weakness and/or coordination issues
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
younger than 18 years, pregnancy, spinal factures and operations, severe forms of scoliosis, cancer, hip diseases

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Timing
Prospective
Statistical methods / analysis
based on confidence level (95%), confidence interval (10), population size (100000), the estimated sample size was 96. Our sample size was 98
Since our primary interest was to see the level of agreement between two raters' measurements, we used the measures of relative and absolute agreement, and these are Intraclass coefficient ICC 2,1"and Standard error of measurement and Minimal Detectable Change
Bland Altman Analysis was used to see if there is systematic error in two raters' measurements

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/08/2011
Actual
1/09/2011
Date of last participant enrolment
Anticipated
1/12/2011
Actual
22/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment outside Australia
Country [1] 5423 0
Serbia and Montenegro
State/province [1] 5423 0
Serbia

Funding & Sponsors
Funding source category [1] 287989 0
Hospital
Name [1] 287989 0
Clinic for Rehabilitation, Medical Faculty University of Belgrade
Country [1] 287989 0
Serbia and Montenegro
Primary sponsor type
Hospital
Name
Clinic for Rehabilitation Medical Faculty University of Belgrade
Address
13 Sokobanjska, Belgrade,
Country
Serbia and Montenegro
Secondary sponsor category [1] 286708 0
None
Name [1] 286708 0
nil
Address [1] 286708 0
nil
Country [1] 286708 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 43078 0
Dr Olivera Djordjevic
Address 43078 0
Medical Faculty University of Belgrade,
Clinic for Rehabilitation, 13 Sokobanjska
Country 43078 0
Serbia and Montenegro
Phone 43078 0
+381658542279
Fax 43078 0
Email 43078 0
[email protected]
Contact person for public queries
Name 43079 0
Olivera Djordjevic
Address 43079 0
Medical Faculty University of Belgrade,
Clinic for Rehabilitation, 13 Sokobanjska
Country 43079 0
Serbia and Montenegro
Phone 43079 0
+381658542279
Fax 43079 0
Email 43079 0
[email protected]
Contact person for scientific queries
Name 43080 0
Olivera Djordjevic
Address 43080 0
Medical Faculty University of Belgrade,
Clinic for Rehabilitation, 13 Sokobanjska
Country 43080 0
Serbia and Montenegro
Phone 43080 0
+381658542279
Fax 43080 0
Email 43080 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.