Primary objective:The study objective is to assess whether there is a difference in prevalence of positive Lyme serology in patients with painful radiculopathy with nerve root compression versus patients with painful radiculopathy without nerve root…
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Source
Brief title
Condition
- Bacterial infectious disorders
- Central nervous system infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are the result of Borrelia serology
(positive/negative) and the result of the MRI scan (yes/no nerve root
compression). Patients with positive Borrelia serology and no nerve root
compression will be offered a lumbar puncture to test for Lyme
neuroborreliosis.
Secondary outcome
-Differences in patient characteristics and additional symptoms of patients
with radiculopathy caused by Lyme neuroborreliosis versus patients with
radiculopathy due to nerve root compression.
Background summary
The Dutch guideline for Lyme borreliosis states that in patients with painful
radiculopathy, serological testing is only indicated if the symptoms are not
explained by nerve root compression on MRI and the patient remembers a tick
bite or EM. Sometimes the EM is still present at physical examination, but it
is also known that many patients with Lyme neuroborreliosis have not noticed
either the tick bite or EM. Positive Borrelia serology in patients with
radiculopathy indicates cerebrospinal fluid examination. Lyme neuroborreliosis
is defined as the presence of CSF pleocytosis and/or intrathecal IgM and/or IgG
Borrelia-specific antibody production.
Although meningoradiculitis, with symptoms of painful radiculopathy is the most
common presentation of early Lyme neuroborreliosis, it is unknown how often
Lyme neuroborreliosis is the cause of painful radiculopathy in the absence of
nerve root compression. A Danish study demonstrated that phycisians often not
consider Lyme neuroborreliosis as a cause of painful radiculopathy, leading to
treatment delay. Possibly, Lyme neuroborreliosis is currently underdiagnosed as
a cause of painful radiculopathy. If a substantial number of patients with
painful radiculopathy turns out to have positive Lyme serology, we advise to
update the Lyme guidelines including standard serological testing for Lyme
borreliosis in patients with painful radiculopathy.
Study objective
Primary objective:
The study objective is to assess whether there is a difference in prevalence of
positive Lyme serology in patients with painful radiculopathy with nerve root
compression versus patients with painful radiculopathy without nerve root
compression.
Secondary objectives:
1. To assess the prevalence of Lyme neuroborreliosis in patients with painful
radiculopathy without nerve root compression.
2. To assess a difference in patient characteristics (i.e. difference in type
of pain, location pain, additional symptoms (headache/meningeal irritation),
previous tick bite, previous EM, tick exposure activities, month of
presentation) of patients with radiculopathy caused by Lyme neuroborreliosis
versus patients with painful radiculopathy due to nerve root compression.
Study design
The design is an observational cross-sectional study among patients who are
referred to the neurology outpatient clinic of Gelre hospitals for the
indication of radiculopathy. All patients who undergo an MRI scan of (a part
of) the spinal column for the suspected radiculopathy will be eligible for
inclusion in the study.
In patients who are willing to participate, serology will be tested for
Borrelia, irrespective of history of tick bite or history of EM. In case of
positive Borrelia serology in the absence of nerve root compression on MRI, the
patient will be offered a lumbar puncture for diagnosis of Lyme
neuroborreliosis. If Lyme neuroborreliosis is diagnosed, the patient will be
treated according to the guidelines. In case of negative Borrelia serology
within eight weeks of symptom onset, in the absence of nerve root compression,
Borrelia serology will be tested again after eight weeks of symptom onset. If
seroconversion occurs, a lumbar puncture will be offered.
Study burden and risks
Risk associated with participation are minimal, as a venipuncture is the only
procedure patients will undergo. The benefit is that underdiagnosis of Lyme
neuroborreliosis is unlikely and these patients receive timely and adequate
treatment.
Albert Schweitzerlaan 31
Apeldoorn 7334 DZ
NL
Albert Schweitzerlaan 31
Apeldoorn 7334 DZ
NL
Listed location countries
Age
Inclusion criteria
- All patients visiting the neurology outpatient clinic of Gelre hospitals who
undergo an MRI scan for the indication of painful radiculopathy
- 18 years or older
- Given informed consent for participation in the study
Exclusion criteria
- Patients who undergo an MRI scan for other reasons than radiculopathy
- Patients who have radiculopathy as a residual symptom after being adequately
treated for Lyme neuroborreliosis
- Patients with a known other explanation for radiculopathy at time of
referral, for example leptomeningeal metastasis or varicella zoster infection
Design
Recruitment
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 |
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CCMO | NL79263.075.22 |