ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

low back pain

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

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]

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]

lumbar multifidus muscle and transverse abdominal muscle thickness measured by ultrasound caliper at rest and during muscle contraction

Timepoint [1]

three concecutive days

Primary outcome [2]

Intraclass correlation coefficient ICC2,1

Timepoint [2]

three days

Secondary outcome [1]

nil

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Serbia and Montenegro

State/province [1]

Serbia

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Clinic for Rehabilitation, Medical Faculty University of Belgrade

Address [1]

13 Sokobanjska, Belgrade, Serbia

Country [1]

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]

None

Name [1]

nil

Address [1]

nil

Country [1]

Ethics approval

Ethics application status

Approved

Summary

Brief summary

Study design: Two-group repeated-measures reliability study 
Objectives: Determine inter- and intra-rater reliability of ultrasound (US) measurements of transverse abdominis (TrA) and lumbar multifidus (LM) thickness during rest and contraction by an experienced and a novice raters.
Background: No previous reliability study included larger samples of low back pain (LBP) and healthy subjects, assessed thickness of TrA and LM during rest and contraction, over several days, and by raters with different experience.
Methods:  Two blinded raters measured TrA and LM thickness in 42 healthy and 56 LBP subjects during rest and contraction over 3 consecutive days. The thickness change from rest to contraction was also calculated (%).  Intraclass correlation coefficients (ICC2,k) and 95% minimal detectable differences (MDC95) were derived.
Results: Inter-rater ICC2,1 for single-measure muscle thickness were 0.71-0.87 for LBP subjects and 0.94-1.0 for healthy subjects.  The inter-rater ICC2,3 for averaged measures over 3 days were similar (LBP 0.73-0.84, healthy 0.93-1.0).  Both single-measure ICC2,1 and average-measure ICC2,3 were lower for the relative thickness change (0.61-0.96). Intra-rater ICC2,1 across 3 days were high for both raters (LBP 0.95-1.00, healthy 0.93-1.00), albeit lower for the relative thickness change (0.79-0.99). The MDC95 were <10% of the respective muscle thickness means.
Conclusion: Good-to-excellent reliability was found for US measurements of TrA and LM muscle thickness performed by the experienced and novice raters in subjects with and without LBP.  One-time thickness measurements appear sufficient. The estimates of absolute measurement error (MDC95) indicate that >10% difference in muscle thickness may be considered true change over time.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Olivera Djordjevic

Address

Medical Faculty University of Belgrade,
Clinic for Rehabilitation, 13 Sokobanjska

Country

Serbia and Montenegro

Phone

+381658542279

Fax

odordev@eunet.rs

Contact person for public queries

Name

Olivera Djordjevic

Address

Medical Faculty University of Belgrade,
Clinic for Rehabilitation, 13 Sokobanjska

Country

Serbia and Montenegro

Phone

+381658542279

Fax

odordev@EUnet.rs

Contact person for scientific queries

Name

Olivera Djordjevic

Address

Medical Faculty University of Belgrade,
Clinic for Rehabilitation, 13 Sokobanjska

Country

Serbia and Montenegro

Phone

+381658542279

Fax

odordev@EUnet.rs

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.

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