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OpenTrials
Completed

NCT Number: NCT00924495

Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain

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.

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Key information

Age range

25 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital

Kuopio, 70211, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Magnetic Stimulation

Device

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

Primary outcomes

  1. Correlation between cortical activity and other motor control tests

    Time frame: day 1 and day 19

Secondary outcomes

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

    Time frame: day 19, 1 month, 2 months, 1 year

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Official study title

Regulatory Central Mechanisms in Chronic Nonspecific Low Back Pain With Lumbar Dysfunction

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 19, 2009
Registry last updated
Feb 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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