Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain

February 10, 2013 updated by: olavi airaksinen, Kuopio University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70211
        • Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between cortical activity and other motor control tests
Time Frame: day 1 and day 19
day 1 and day 19

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 18, 2009

First Submitted That Met QC Criteria

June 18, 2009

First Posted (Estimate)

June 19, 2009

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 10, 2013

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5960429

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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