Effect of Infection, Modic and Inflammation on Clinical Outcomes in Radiculopathy 2

Effect of Infection, Modic and Inflammation on Clinical Outcomes in Radiculopathy 2 - EIMICOR 2

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52609

Enrollment

320

Registered

2021-04-01

Start date

2022-01-29

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

disc herniation hernia radicular syndrome

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Lumbar patients: - Age 18-75 - a unilateral lumbosacral radicular syndrome, with at least the following criteria: - Radicular incitement: radiating pain from (a part of the) dermatome L4, L5 and/or S1 (obligatory). o Radiculopathy: abovementioned pain + paresis (MRC grade > 3) of the myotome and/or dysesthesia in (a part of) the dermatome and/or lowered or no knee reflex or Achilles heel reflex (not obligatory). o Present for at least 8 weeks - MRI verified lumbosacral disc herniation that is corresponding to the side of the symptoms (obligatory) - Indication for surgery (obligatory) - Informed consent (obligatory), Cervical patients: - Age 18-75 - a unilateral cervical radicular syndrome, with at least the following criteria: o Radicular incitement: radiating pain from (a part of the) dermatome C45, C56, C67 and/or C7T1 (obligatory). o Radiculopathy: abovementioned pain + mild paresis (MRC grade > 3) (not obligatory). o Present for at least 8 weeks - MRI verified cervical disc herniation that is corresponding to the side of the symptoms (obligatory) - Indication for surgery (obligatory) - Informed consent (obligatory)

Exclusion criteria

Exclusion criteria: Lumbar: - Previous lumbar spinal surgery or chemonucleolysis - Paresis of MRC

Design outcomes

Primary

Measure	Time frame
This study will explore the effects and interactions of bacterial infection, disc inflammation and Modic Changes on the clinical outcome of patients with cervical or lumbar disc herniation. To assess these effects, a mean difference over the course of one-year follow-up of 2-point difference on a 11 point NRS scale will be regarded as clinical relevant and thus used as main study parameter.	—

Secondary

Measure	Time frame
1. A secondary aim of this study is to assess whether patients that suffer from disc inflammation benefit more from anti-inflammatory drugs than those without inflammation. 2. Another secondary aim of this study is to further explore the inflammation process by characterizing different types of macrophages (M1 and M2) and B and T cells. 3. At last this study aims to associate the presence of bacterial infection to the presence and type of Modic Changes.	—

Measure

Time frame

1. A secondary aim of this study is to assess whether patients that suffer from disc inflammation benefit more from anti-inflammatory drugs than those without inflammation. 2. Another secondary aim of this study is to further explore the inflammation process by characterizing different types of macrophages (M1 and M2) and B and T cells. 3. At last this study aims to associate the presence of bacterial infection to the presence and type of Modic Changes.

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Countries

Netherlands

Outcome results