NCT01979783

Brief Summary

Transversus abdominis (TrA) and lumbar multifidus (LM) muscle have been proposed to play key role in stability of the lumbosacral spine. The muscles' functional and/or structural deficits have been linked to the low back pain (LBP) syndrome. Evaluation of the transversus abdominis and lumbar multifidus muscles' function in clinical practice is scarce and not well defined due to number of reasons. Surface electromyography of TrA and LM muscles, as a method of examining muscles function, is not involved in clinical routine. Rehabilitative Ultrasound Imaging (RUSI) of the TrA and LM, apart from providing information about their morphology, could be helpful in assessing their function. Since concentric muscle contraction results in the shortening and thickening of the muscle, evaluation of the potential association between muscle's morphometry, assessed by the ultrasound, and electromyography, may be of potential clinical interest. However, this potential relationship is context-dependant. Our aim was to establish the difference in the thickness change of the TrA and LM muscle during activation in subjects with and without low back pain, and to establish the possible correlation between electromyography and the thickness change of these muscles assessed by ultrasound in both groups of subjects.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

November 8, 2013

Status Verified

November 1, 2013

Enrollment Period

2 months

First QC Date

October 28, 2013

Last Update Submit

November 7, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • thickness of the lumbar multifidus and transversus abdominis muscle

    1 day

Study Arms (2)

LBP

group of subjects with low back pain

nonLBP

group without low back pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

tertiary care clinic

You may qualify if:

  • Low back pain, with or without radiculopathy, that lasted for at least 12 weeks, caused by prolapsed intervertebral disc (PID), confirmed by magnetic resonance imaging (MRI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Rehabilitation Dr Mirsoslav Zotovic Faculty of Medicine University of Belgrade

Belgrade, 11000, Serbia

Location

Related Publications (1)

  • Djordjevic O, Konstantinovic L, Miljkovic N, Bijelic G. Relationship Between Electromyographic Signal Amplitude and Thickness Change of the Trunk Muscles in Patients With and Without Low Back Pain. Clin J Pain. 2015 Oct;31(10):893-902. doi: 10.1097/AJP.0000000000000179.

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Olivera Djordjevic, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 8, 2013

Study Start

November 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

November 8, 2013

Record last verified: 2013-11

Locations