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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01979783
Other study ID # EMGUS
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 28, 2013
Last updated November 7, 2013
Start date November 2013
Est. completion date January 2014

Study information

Verified date November 2013
Source University of Belgrade
Contact Olivera Djordjevic, MD
Email odordev@EUnet.rs
Is FDA regulated No
Health authority Serbia: Ethics Committee
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

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)

Exclusion Criteria:

The exclusion criteria for all participants were pregnancy,diabetes mellitus,corticosteroids administrated in one months or less prior to enrollment, spinal fractures, surgery, infectious diseases, tumors, spina bifida, advanced forms of spinal deformity, hip diseases, and neuromuscular disorders. Additional exclusion criteria for LBP participants were self-reported pain levels of less than 3 on the Visual Analog Scale to account for patients commonly encountered in clinical practice, and inability to remain in prone and supine hook-lying positions for 10 minutes each in order to ensure compliance.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Serbia Clinic for Rehabilitation Dr Mirsoslav Zotovic Faculty of Medicine University of Belgrade Belgrade

Sponsors (1)

Lead Sponsor Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary thickness of the lumbar multifidus and transversus abdominis muscle 1 day No
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