Chronic Nonspecific Low Back PainNCT00924495
Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain
A study testing transcranial magnetic stimulation in people with Chronic Nonspecific Low Back Pain, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to explore the cortical regulation of the paraspinal muscles in chronic low back pain. These (possible) changes in regulatory mechanisms are being compared to other motor control tests in order to determine whether correlations are found. Read more about this study
- Who is it for?
- Ages 25 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Nonspecific Low Back Pain
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2009to Sep 2012
- Phase
- Interventional
- 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 25 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- chronic nonspecific low back pain for at least six months
- male gender
- age 25-50 yrs
- average pain during last week 4-8/10 by VAS
- Oswestry disability index 20-80 %
Who cannot join
- former spinal operations
- rheumatic disease, marked spondylolysis and -olisthesis, other diseases that markedly reduce physical or psychological performance, history of epilepsy, history of taking epileptic or strong opioid drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regulatory Central Mechanisms in Chronic Nonspecific Low Back Pain With Lumbar Dysfunction
The purpose of this study is to explore the cortical regulation of the paraspinal muscles in chronic low back pain. These (possible) changes in regulatory mechanisms are being compared to other motor control tests in order to determine whether correlations are found. Furthermore the patients are being treated with repetitive transcranial magnetic stimulation (rTMS) and tested afterwards. The purpose is to find out if rTMS-therapy is capable of normalizing motor control deficits.
- Conditions
- Chronic Nonspecific Low Back Pain
- Being tested
- transcranial magnetic stimulation
- Keywords
- low back pain, motor control, cortical regulation, transcranial magnetic stimulation
- 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.
transcranial magnetic stimulationDevice
rTMS therapy daily for two weeks, five times per week each lasting for half an hour
| Study group | Role | What they receive |
|---|---|---|
| Cortical function | Active comparator | Activity/inhibition of the cortex Receives: Device: transcranial magnetic stimulation |
| Cortical regulation | Active comparator | Not described Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between cortical activity and other motor control tests
Measured: day 1 and day 19
Secondary outcomes (1)
The effect of rTMS-therapy for clinical outcome and motor control tests
Measured: day 19, 1 month, 2 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Nonspecific 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, olavi airaksinen, Kuopio University Hospital
- Investigators
- Marja T Kilpiäinen, MD, Principal investigator, Kuopio University HospitalMarkku Kankaanpää, MD,PhD, Study director, Tampere University HospitalOlavi Airaksinen, MD, PhD, Study chair, Kuopio University HospitalTimo Miettinen, MD,PhD, Study chair, Kuopio University HospitalEeva Leino, MD,PhD, Study chair, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924495
- Sponsor's protocol ID
- KUH5960429
- Status last verified
- Sep 2012
- First submitted
- 18 Jun 2009
- Last updated
- 12 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory Central Mechanisms in Chronic Nonspecific Low Back Pain With Lumbar Dysfunction
- ClinicalTrials.gov ID
- NCT00924495
- Acronym / sponsor ID
- KUH5960429
- Conditions
- Chronic Nonspecific Low Back Pain
- Keywords
- low back pain, motor control, cortical regulation, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 19 Jun 2009 (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.
The purpose of this study is to explore the cortical regulation of the paraspinal muscles in chronic low back pain. These (possible) changes in regulatory mechanisms are being compared to other motor control tests in order to determine whether correlations are found. Furthermore the patients are being treated with repetitive transcranial magnetic stimulation (rTMS) and tested afterwards. The purpose is to find out if rTMS-therapy is capable of normalizing motor control deficits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cortical function | Active comparator | Device: transcranial magnetic stimulationActivity/inhibition of the cortex |
| Cortical regulation | Active comparator | Device: transcranial magnetic stimulation |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- chronic nonspecific low back pain for at least six months
- male gender
- age 25-50 yrs
- average pain during last week 4-8/10 by VAS
- Oswestry disability index 20-80 %
Key exclusion criteria (2 listed)
- former spinal operations
- rheumatic disease, marked spondylolysis and -olisthesis, other diseases that markedly reduce physical or psychological performance, history of epilepsy, history of taking epileptic or strong opioid drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial magnetic stimulationrTMS therapy daily for two weeks, five times per week each lasting for half an hour | Device | Cortical function, Cortical regulation |
Primary outcome
Correlation between cortical activity and other motor control tests
Time frame: day 1 and day 19
1 secondary outcome
The effect of rTMS-therapy for clinical outcome and motor control tests
Time frame: day 19, 1 month, 2 months, 1 year
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 12 Feb 2013.
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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.
Marja T Kilpiäinen, MD principal investigator
Kuopio University Hospital
Markku Kankaanpää, MD,PhD study director
Tampere University Hospital
Olavi Airaksinen, MD, PhD study chair
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation in people with Chronic Nonspecific Low Back Pain, run by Kuopio University Hospital at 1 site in Finland.
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 5 inclusion and 2 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 12 Feb 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 Finland. 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.
What does the primary outcome measure?
Correlation between cortical activity and other motor control tests (time frame: day 1 and day 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2013.