Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
olavi airaksinen, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00924495
First received: June 18, 2009
Last updated: February 10, 2013
Last verified: September 2012
  Purpose

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 Intervention
Chronic Nonspecific Low Back Pain
Device: transcranial magnetic stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Regulatory Central Mechanisms in Chronic Nonspecific Low Back Pain With Lumbar Dysfunction

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • Correlation between cortical activity and other motor control tests [ Time Frame: day 1 and day 19 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The effect of rTMS-therapy for clinical outcome and motor control tests [ Time Frame: day 19, 1 month, 2 months, 1 year ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: June 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 18, 2009
Last Updated: February 10, 2013
Health Authority: Finland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 25, 2014