Clinical trial NCT00479063: Association of Lumbar MODIC Changes With Chronic Low Back Pain in Southern European Subjects
Official title: Modic Changes Are Not Associated With a Higher Risk of Chronic Low Back Pain Among Southern European Subjects. A Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: MODIC changes
chronic low back pain
magnetic resonance imaging (MRI)
vertebrae
intervertebral disc
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
First posted: 2007-05-25
Enrollment: 304
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


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.

Exclusion criteria were: history of spine surgery, current pregnancy, scoliosis with \>15º curvature, vertebral fractures, "red flags" for potential underlying systemic diseases (oncologic disease during the previous 5 years, constitutional symptoms -unexplained weight loss, fever, chills-, history of intravenous drug use, or immunocompromised host), or signs suggesting cauda equine syndrome (relevant or progressive paresia, loss of sphincter control or saddle anesthesia).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Kovacs Foundation
state: Balearic Islands
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: IbSalut, Palma de Mallorca, Spain
name: Carlos Campillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.