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

NCT ID: NCT00479063

Last Updated: 2011-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 304 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-05-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kovacs Foundation

OTHER

Sponsor Role: lead

Responsible Party

Kovacs Foundation

Principal Investigators

Francisco M Kovacs, MD, PhD

Role: STUDY_DIRECTOR

Kovacs Foundation, Palma de Mallorca, Spain

Carlos Campillo, MD

Role: PRINCIPAL_INVESTIGATOR

IbSalut, Palma de Mallorca, Spain

Locations

Kovacs Foundation

Palma de Mallorca, Balearic Islands, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 3336678 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8083266 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11438138 (View on PubMed)

Other Identifiers

FK-R-16

Identifier Type: -

Identifier Source: org_study_id