Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain

Chronic Nonspecific Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924495
• Other study ID #: KUH5960429
• Status: Completed
• Phase: N/A
• First received: June 18, 2009
• Last updated: February 10, 2013
• Start date: June 2009
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Back Pain
• Chronic Nonspecific Low Back Pain
• Low Back Pain

Intervention

Device:
• transcranial magnetic stimulation
rTMS therapy daily for two weeks, five times per week each lasting for half an hour

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between cortical activity and other motor control tests		day 1 and day 19	No
Secondary	The effect of rTMS-therapy for clinical outcome and motor control tests		day 19, 1 month, 2 months, 1 year	No