Low Back PainNCT01979783
Correlation Between Electromyography and Thickness Change of the Trunk Muscles in Subjects With Low Back Pain
An observational study of Low Back Pain, run by University of Belgrade at 1 site in Serbia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 60 participants
- Where
- 1 siteSerbia
- Study dates
- Nov 2013to Jan 2014
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: tertiary care clinic
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Olivera Djordjevic, MD contact
Serbia1 site
Clinic for Rehabilitation Dr Mirsoslav Zotovic Faculty of Medicine University of Belgrade
Belgrade, 11000
About this study
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.
- Conditions
- Low Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LBP | group of subjects with low back pain | |
| nonLBP | group without low back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
thickness of the lumbar multifidus and transversus abdominis muscle
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivera Djordjevic, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979783
- Sponsor's protocol ID
- EMGUS
- Status last verified
- Nov 2013
- First submitted
- 28 Oct 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
Publications
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.
PubMed 25380224
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Electromyography and Thickness Change of the Trunk Muscles in Subjects With Low Back Pain
- ClinicalTrials.gov ID
- NCT01979783
- Acronym / sponsor ID
- EMGUS
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBP | – | –group of subjects with low back pain |
| nonLBP | – | –group without low back pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary care clinic
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
thickness of the lumbar multifidus and transversus abdominis muscle
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Derived from this study: PubMed 25380224Djordjevic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivera Djordjevic, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivera Djordjevic, MD (odordev@EUnet.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thickness of the lumbar multifidus and transversus abdominis muscle (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01979783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.