Low Back PainNCT00184535
Recording Methods of Muscle Activity "Onset".
An observational study of Low Back Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Delayed anticipatory muscle activity response in deep low back and abdominal muscles has been observed in patients with low back pain, indicative of a pathological condition. Muscle activity onset is traditionally recorded by intramuscular electromyography, but there is a need for a less cumbersome recording method in… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2005to Oct 2005
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy men and women between 30-65 yrs with no recent low back pain
Who may be able to join
- Healthy
- 30-65 yrs
Who cannot join
- recent low back pain
- low back, neck or shoulder pain inflicting work absence or bed rest
- cardiac, rheumatic or other serious illness
- pregnancy
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian University of Science and Technology (NTNU), Nasjonal senter for spinale lidelser
Trondheim, 7489
About this study
Official title: Muscle Activity "Onset" in the Transversus Abdominis - Simultaneous Recordings by Intramuscular Electromyography and High Frame Rate Ultrasound Imaging.
Delayed anticipatory muscle activity response in deep low back and abdominal muscles has been observed in patients with low back pain, indicative of a pathological condition. Muscle activity onset is traditionally recorded by intramuscular electromyography, but there is a need for a less cumbersome recording method in large clinical studies. The purpose of this experimental study is to explore whether high-frame rate m-mode ultrasound and tissue velocity imaging could measure anticipatory muscle responses ("onset") in the abdominal muscles reliably and comparably accurate to intramuscular EMG.
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Neuromuscular control, Anticipatory motor control, Musculoskeletal Physiologic Processes, Muscle, Skeletal, Ultrasonography, Electromyography
- Medical subject headings
- Low Back Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionOct 2005
- Study completionOct 2005
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.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Responsible party
- Sponsor
- Investigators
- Ottar Vasseljen, PhD, Study chair, Norw. Univ of Sci and Technol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184535
- Sponsor's protocol ID
- REK 4.2005.885
- Status last verified
- Sep 2017
- First submitted
- 15 Sep 2005
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vasseljen O, Dahl HH, Mork PJ, Torp HG. Muscle activity onset in the lumbar multifidus muscle recorded simultaneously by ultrasound imaging and intramuscular electromyography. Clin Biomech (Bristol). 2006 Nov;21(9):905-13. doi: 10.1016/j.clinbiomech.2006.05.003. Epub 2006 Jul 5.
PubMed 16822599
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Activity "Onset" in the Transversus Abdominis - Simultaneous Recordings by Intramuscular Electromyography and High Frame Rate Ultrasound Imaging.
- ClinicalTrials.gov ID
- NCT00184535
- Acronym / sponsor ID
- REK 4.2005.885
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Neuromuscular control, Anticipatory motor control, Musculoskeletal Physiologic Processes, Muscle, Skeletal, Ultrasonography, Electromyography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- Jul 2005 (actual)
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 16 Sep 2005 (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.
Delayed anticipatory muscle activity response in deep low back and abdominal muscles has been observed in patients with low back pain, indicative of a pathological condition. Muscle activity onset is traditionally recorded by intramuscular electromyography, but there is a need for a less cumbersome recording method in large clinical studies. The purpose of this experimental study is to explore whether high-frame rate m-mode ultrasound and tissue velocity imaging could measure anticipatory muscle responses ("onset") in the abdominal muscles reliably and comparably accurate to intramuscular EMG.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy men and women between 30-65 yrs with no recent low back pain
Key inclusion criteria (2 listed)
- Healthy
- 30-65 yrs
Key exclusion criteria (4 listed)
- recent low back pain
- low back, neck or shoulder pain inflicting work absence or bed rest
- cardiac, rheumatic or other serious illness
- pregnancy
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Results publication: PubMed 16822599Vasseljen O, Dahl HH, Mork PJ, Torp HG. Muscle activity onset in the lumbar multifidus muscle recorded simultaneously by ultrasound imaging and intramuscular electromyography. Clin Biomech (Bristol). 2006 Nov;21(9):905-13. doi: 10.1016/j.clinbiomech.2006.05.003. Epub 2006 Jul 5.
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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.
Ottar Vasseljen, PhD study chair
Norw. Univ of Sci and Technol
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 Norwegian University of Science and Technology at 1 site in Norway.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 25 Sep 2017. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184535, 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 25 Sep 2017; AzTrials last refreshed its copy on 3 Nov 2026.