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Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain

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ClinicalTrials.gov Identifier: NCT00924495
Recruitment Status : Completed
First Posted : June 19, 2009
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
olavi airaksinen, Kuopio University Hospital

June 18, 2009
June 19, 2009
February 12, 2013
June 2009
September 2012   (Final data collection date for primary outcome measure)
Correlation between cortical activity and other motor control tests [ Time Frame: day 1 and day 19 ]
Same as current
Complete list of historical versions of study NCT00924495 on ClinicalTrials.gov Archive Site
The effect of rTMS-therapy for clinical outcome and motor control tests [ Time Frame: day 19, 1 month, 2 months, 1 year ]
Same as current
Not Provided
Not Provided
 
Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Chronic Nonspecific Low Back Pain
Device: transcranial magnetic stimulation
rTMS therapy daily for two weeks, five times per week each lasting for half an hour
  • Active Comparator: Cortical function
    Activity/inhibition of the cortex
    Intervention: Device: transcranial magnetic stimulation
  • Active Comparator: Cortical regulation
    Intervention: Device: transcranial magnetic stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
Same as current
September 2012
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 %

Exclusion Criteria:

  • 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
Sexes Eligible for Study: Male
25 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT00924495
KUH5960429
Not Provided
Not Provided
Not Provided
olavi airaksinen, Kuopio University Hospital
Kuopio University Hospital
Not Provided
Principal Investigator: Marja T Kilpiäinen, MD Kuopio University Hospital
Study Director: Markku Kankaanpää, MD,PhD Tampere University Hospital
Study Chair: Olavi Airaksinen, MD, PhD Kuopio University Hospital
Study Chair: Timo Miettinen, MD,PhD Kuopio University Hospital
Study Chair: Eeva Leino, MD,PhD Tampere University Hospital
Kuopio University Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP