Association of Lumbar MODIC Changes With Chronic Low Back Pain in Southern European Subjects

NCT00479063 | Completed DMC

• 1 other identifier: FK-R-16
• Study Type: observational
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

In this case-control study, cases were chronic LBP patients aged 30-50 in whom a lumbar MRI had been prescribed. Controls were subjects aged 30-50 in whom a cranial MRI had been prescribed for headache, who did not suffer from LBP and had no history of clinically relevant LBP. Two hundred and forty cases and 64 controls were recruited consecutively in Radiology services across six cities in Spain. Imaging findings and subjects' characteristics were gathered through previously validated instruments. Radiologists who interpreted MRIs were blinded to subjects' characteristics. A multivariate logistic regression model was developed to assess the association of Modic changes with LBP, adjusting for sex, age, body-mass index, lifetime exposure to smoking, physical activity, and disk degeneration.

Conditions

Low Back Pain

Keywords

MODIC changes; chronic low back pain; magnetic resonance imaging (MRI); vertebrae; intervertebral disc

Study Arms (2)

Cases

All subjects screened for this study were aged 30 to 50 years, had been referred to participating Radiology services, and underwent a lumbar MRI. Cases had been referred for a lumbar MRI for LBP lasting \> 90 days.

Controls

All subjects screened for this study were aged 30 to 50 years, had been referred to participating Radiology services, and underwent a lumbar MRI. Controls were headache patients who had been referred for a cranial MRI, which turned out to be normal, and who either had no history of LBP or had only experienced one episode in their life, which had lasted for less than 7 days.

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Cases: chronic LBP patients aged 30-50 in whom a lumbar MRI had been prescribed. Controls: subjects aged 30-50 in whom a cranial MRI had been prescribed for headache, who did not suffer from LBP and had no history of clinically relevant LBP.

You may qualify if:

• For all subjects: age between 35 and 50 years.
• For subjects with LBP: having a diagnosis of chronic low back pain (of 3 or more months' duration) as the reason for an MRI.
• For subjects without LBP: subjects with a cranial MRI (described as normal) for cephalalgia, and who had neither current LBP nor history of LBP.

Sponsors & Collaborators

• Kovacs Foundation: lead

Study Sites (1)

Kovacs Foundation

Palma de Mallorca, Balearic Islands, 07012, Spain

Location

Related Publications (3)

• Modic MT, Steinberg PM, Ross JS, Masaryk TJ, Carter JR. Degenerative disk disease: assessment of changes in vertebral body marrow with MR imaging. Radiology. 1988 Jan;166(1 Pt 1):193-9. doi: 10.1148/radiology.166.1.3336678.

  PMID: 3336678 BACKGROUND

• Toyone T, Takahashi K, Kitahara H, Yamagata M, Murakami M, Moriya H. Vertebral bone-marrow changes in degenerative lumbar disc disease. An MRI study of 74 patients with low back pain. J Bone Joint Surg Br. 1994 Sep;76(5):757-64.

  PMID: 8083266 BACKGROUND

• Stirling A, Worthington T, Rafiq M, Lambert PA, Elliott TS. Association between sciatica and Propionibacterium acnes. Lancet. 2001 Jun 23;357(9273):2024-5. doi: 10.1016/S0140-6736(00)05109-6. No abstract available.

  PMID: 11438138 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francisco M Kovacs, MD, PhD

  Kovacs Foundation, Palma de Mallorca, Spain

  STUDY DIRECTOR

• Carlos Campillo, MD

  IbSalut, Palma de Mallorca, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2007
• First Posted: May 25, 2007
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: May 1, 2011
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

ES (1)