Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain

NCT ID: NCT00924495

Last Updated: 2013-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Nonspecific Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Cortical function

Activity/inhibition of the cortex

Group Type ACTIVE_COMPARATOR

transcranial magnetic stimulation

Intervention Type DEVICE

rTMS therapy daily for two weeks, five times per week each lasting for half an hour

Cortical regulation

Group Type ACTIVE_COMPARATOR

transcranial magnetic stimulation

Intervention Type DEVICE

rTMS therapy daily for two weeks, five times per week each lasting for half an hour

Interventions

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transcranial magnetic stimulation

rTMS therapy daily for two weeks, five times per week each lasting for half an hour

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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olavi airaksinen

MD, PhD Ass Proff, Head of the Department of Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marja T Kilpiäinen, MD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Markku Kankaanpää, MD,PhD

Role: STUDY_DIRECTOR

Tampere University Hospital

Olavi Airaksinen, MD, PhD

Role: STUDY_CHAIR

Kuopio University Hospital

Timo Miettinen, MD,PhD

Role: STUDY_CHAIR

Kuopio University Hospital

Eeva Leino, MD,PhD

Role: STUDY_CHAIR

Tampere University Hospital

Locations

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Kuopio University Hospital

Kuopio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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KUH5960429

Identifier Type: -

Identifier Source: org_study_id

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