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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

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Chronic Nonspecific Low Back Pain Device: transcranial magnetic stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Regulatory Central Mechanisms in Chronic Nonspecific Low Back Pain With Lumbar Dysfunction
Study Start Date : June 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Cortical function
Activity/inhibition of the cortex
Device: transcranial magnetic stimulation
rTMS therapy daily for two weeks, five times per week each lasting for half an hour
Active Comparator: Cortical regulation Device: transcranial magnetic stimulation
rTMS therapy daily for two weeks, five times per week each lasting for half an hour



Primary Outcome Measures :
  1. Correlation between cortical activity and other motor control tests [ Time Frame: day 1 and day 19 ]

Secondary Outcome Measures :
  1. The effect of rTMS-therapy for clinical outcome and motor control tests [ Time Frame: day 19, 1 month, 2 months, 1 year ]


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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924495


Locations
Finland
Kuopio University Hospital
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
Investigators
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

Responsible Party: olavi airaksinen, MD, PhD Ass Proff, Head of the Department of Rehabilitation, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00924495     History of Changes
Other Study ID Numbers: KUH5960429
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: September 2012

Keywords provided by olavi airaksinen, Kuopio University Hospital:
low back pain
motor control
cortical regulation
transcranial magnetic stimulation

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms