The Efficacy of Zoledronic Acid in Modic Changes-related Low Back Pain (LBP)

University of Oulu40 enrolled

Overview

Modic changes are associated with low back pain (LBP) both in clinical and general population-based samples. Type I changes are regarded as more likely to be painful than type II changes. Several studies suggest that type I changes are inflammatory in nature.

So far, no treatment exists for LBP due to Modic changes. Bisphosphonates could be effective in this specific low back disorder through two mechanisms: 1) they could consolidate vertebral bodies thereby improving the tolerance for mechanical load and 2) they could diminish inflammation as observed recently in case of ibandronate in an experimental model.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Low Back Pain

Interventions

Zoledronic acid vs. placeboDRUG

Single infusion of zoledronic acid or placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age over 18 years old * low back pain for more than 3 months * Modic type I or II change in lumbar magnetic resonance imaging * Intensity of low back pain at least 6 on 10-cm VAS or Oswestry disability score at least 30% Exclusion Criteria: * premenopausal female patients with possibility of pregnancy * patients with calculated creatinine clearance of less than 40 ml/min * patients with hypocalcemia * patients with known hypersensitivity to zoledronic acid or other bisphosphonates or ingredients of the infusional product * patients with red flags symptoms * patients with nerve root impingement * patients with willingness for early retirement

Locations (1)

Institute of Clinical Sciences, Department of Physical and Rehabilitation Medicine, University of Oulu

Oulu, Finland

Outcomes

Primary Outcomes

Low back pain (VAS)

Time frame: 0, 1, 12 months

Secondary Outcomes

Health-related quality of life (RAND-36)

Time frame: 0, 1, 12 months

Flexibility of the lumbar spine

Modified Schober measure

Time frame: 0, 1, 12 months

Sick leaves

Patient-reported

Time frame: 0, 12 months

Radiologic phenotype

Change in proportion and size of type I changes

Time frame: 0, 12 months

Disability (Oswestry)

Time frame: 0, 1, 12 months

Data from ClinicalTrials.gov

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