BackToBasic: Infliximab in Chronic Low Back Pain and Modic Changes
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Low-Back Pain (LBP) is the leading cause of disability worldwide. Even though LBP relates to
      different underlying pathologies, there are a substantial number of patients with chronic
      complaints that have vertebral bone marrow lesions visualized as Modic changes (MC) on
      magnetic resonance imaging (MRI). Despite the clinical evidence that MC is painful, the
      etiology is unknown and there is currently no established treatment. It has been suggested
      that MCs are secondary to a biomechanically induced degradation with a subsequent autoimmune
      response, supported by evidence showing that Tumor necrosis factor (TNF)-α plays a critical
      role in intervertebral disc degeneration and MCs. Clinical trials suppressing inflammation
      with TNF-alfa blockers in patients with acute low back pain and sciatica provide evidence to
      support the initiation of a clinical trial assessing the effect of TNF-alfa blockers in
      patients with chronic low-back pain and MCs. Since TNF-alfa blockers is an established
      treatment for immune-mediated disorders like spondyloarthritis by reducing pain as well as
      bone marrow lesions, the researchers aim to assess whether this treatment is effective for
      chronic LBP with MCs. In addition refine diagnostic assessment and explore potential
      biomarkers, which will provide an increased understanding of underlying factors causing LBP,
      and ultimately result in better management and treatment for one of the most costly and
      challenging patient populations.
    

Detailed description: 
      The following information will be collected at baseline, in addition to pre-specified
      efficacy assessments: age, gender, BMI (measured at site), ethnicity, marital status,
      children, educational level, work status, physical work load, leisure time activity, smoking
      habits, expectations about treatment effect and characteristics of pain (duration, agrevating
      factors, morning stiffness, morning pain, relief by NSAIDs, night time pain and former
      treatment). Emotional distress will be measured using the Hopkins Symptom Checklist-25 at
      baseline. The researchers will measure fear-avoidance beliefs about physical activity and
      work with Fear-avoidance beliefs Questionnaire (FABQ) at baseline. Subjective health
      complaints (SHC) will be measured using a formal inventory which consists of 29 questions
      concerning severity and duration of subjective somatic and psychological complaints and will
      be measured at baseline. In addition, routine clinical investigations (pain provocation tests
      (springing test, active flexion / extension of the lumbar spine) and neurological tests
      (strength, toe-/heel walking, sensibility, reflexes, straight leg raising test, reverse
      Lasegue test)) will be structured and registered in the CRF at baseline.
    

Intervention name(s): Biosimilar Infliximab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Intravenous infusion(5 mg/kg). Each participant will be given 4 infusions, at day 0, day 14, day 42 and day 98, unless unacceptable toxicity is encountered.; Intravenous infusion. Each participant will be given 4 infusions, at day 0, day 14, day 42 and day 98,
Other intervention name(s): NaCl intravenous infusion
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Modic changes; biomarkers; treatment; infliximab; chronic low back pain