search
Back to results

Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain

Primary Purpose

Chronic Nonspecific Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
transcranial magnetic stimulation
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Nonspecific Low Back Pain focused on measuring low back pain, motor control, cortical regulation, transcranial magnetic stimulation

Eligibility Criteria

25 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cortical function

Cortical regulation

Arm Description

Activity/inhibition of the cortex

Outcomes

Primary Outcome Measures

Correlation between cortical activity and other motor control tests

Secondary Outcome Measures

The effect of rTMS-therapy for clinical outcome and motor control tests

Full Information

First Posted
June 18, 2009
Last Updated
February 10, 2013
Sponsor
Kuopio University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00924495
Brief Title
Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain
Official Title
Regulatory Central Mechanisms in Chronic Nonspecific Low Back Pain With Lumbar Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Nonspecific Low Back Pain
Keywords
low back pain, motor control, cortical regulation, transcranial magnetic stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cortical function
Arm Type
Active Comparator
Arm Description
Activity/inhibition of the cortex
Arm Title
Cortical regulation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
transcranial magnetic stimulation
Intervention Description
rTMS therapy daily for two weeks, five times per week each lasting for half an hour
Primary Outcome Measure Information:
Title
Correlation between cortical activity and other motor control tests
Time Frame
day 1 and day 19
Secondary Outcome Measure Information:
Title
The effect of rTMS-therapy for clinical outcome and motor control tests
Time Frame
day 19, 1 month, 2 months, 1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marja T Kilpiäinen, MD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markku Kankaanpää, MD,PhD
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Olavi Airaksinen, MD, PhD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Timo Miettinen, MD,PhD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eeva Leino, MD,PhD
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain

We'll reach out to this number within 24 hrs