To explore the clinical role of infection and inflammation in lumbar and cervical radiculopathy.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Recent findings have suggested that a bacterial infection of the herniated disc
aggravates pain symptoms. This bacterial infection is often associated with the
presence of Modic changes. Besides, evidence indicates that inflammation is
also involved in resorption of herniated tissue as well as pain induction.
Study objective
To explore the clinical role of infection and inflammation in lumbar and
cervical radiculopathy.
Study design
prospective-(longitudinal) observational cohort study
Study burden and risks
During this study, the only burden for subjects will be filling in clinical
questionnaires, and the only risk involved will be inadequate data handling.
Because all the clinical questionnaires won't take longer than one and a half
hour in total for the entire study, and the participating hospitals work with
Good Research Practice (GRP); both the study burden and risks associated with
participation are regarded as negligible. Even though there is no direct gain
for the participants, by participating in this study they may benefit from its
results in the future.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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
Lumbar: - Previous lumbar spinal surgery or chemonucleolysis - Paresis of MRC <
4 - History of spinal inflammatory disease - Instability that requires surgical
fixation - Active infection at the time of surgery - Usage of Anti-biotics in
the past six months - Pregnancy - Inadequate knowledge of the Dutch language ,
Cervical: - Previous cervical spinal surgery - Paresis of MRC < 4 - Myelopathy
as major complaint - History of spinal inflammatory disease - Instability that
requires surgical fixation - Active infection at the time of surgery - Usage of
Anti-biotics in the past six months - Epidural steroid injection in the past
six months - Pregnancy - Inadequate knowledge of the Dutch language
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73413.058.20 |