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
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
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
NCT ID
NCT00924495
First Posted
June 18, 2009
Last Updated
February 10, 2013
Sponsor
Kuopio University Hospital
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
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Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain
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