NCT00924495

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

February 12, 2013

Status Verified

September 1, 2012

Enrollment Period

3.3 years

First QC Date

June 18, 2009

Last Update Submit

February 10, 2013

Conditions

Chronic Nonspecific Low Back Pain

Keywords

low back painmotor controlcortical regulationtranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • Correlation between cortical activity and other motor control tests

    day 1 and day 19

Secondary Outcomes (1)

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

    day 19, 1 month, 2 months, 1 year

Study Arms (2)

Cortical function

ACTIVE COMPARATOR

Activity/inhibition of the cortex

Device: transcranial magnetic stimulation

Cortical regulation

ACTIVE COMPARATOR
Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulationDEVICE

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

Cortical functionCortical regulation

Eligibility Criteria

Age25 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 %

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, 70211, Finland

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Marja T Kilpiäinen, MD

    Kuopio University Hospital

    PRINCIPAL INVESTIGATOR

  • Markku Kankaanpää, MD,PhD

    Tampere University Hospital

    STUDY DIRECTOR

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD Ass Proff, Head of the Department of Rehabilitation

Study Record Dates

First Submitted

June 18, 2009

First Posted

June 19, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

February 12, 2013

Record last verified: 2012-09

Locations

FI(1)