In the literature the effectiveness of the anterior cervical discectomy is measured using subjective validated questionnaires.It would be an important improvement if it is possible to detect the inflammatory process of the dorsal root ganglion with…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter of the additional study is detection of the site of
inflammation of the dorsal root ganglion with FDG-PET/CT. Also, if increased
tracer activity is detected at the site of the affected ganglion, standard
uptake values (SUVs) will be determined. It will be investigated whether the
values of the SUVs correlate with the severity of the patients* complaints and
whether at repeat investigation (after the anterior cervical discectomy) there
is a change in this outcome measurement.
Secondary outcome
The influence of treatment on the intensity of pain, the global perceived
effect.
Background summary
It is often difficult to identify the source of a patient*s spinal pain because
history and physical examination findings are nonspecific; degenerative or
age-related changes in the spine are highly prevalent even in asymptomatic
patients, and pain patterns may overlap secondary to rich anastomoses of
pain-sensing neural structures. Medical imaging is mainly used to exclude
primary pathologies, the so-called *red flags* (e.g., tumor, infection, and
fractures). Computed tomography (CT) scans are able to reproduce the changes in
bone structure, but they have limitations in detecting soft tissue lesions.
Magnetic resonance images (MRI) is better suited to demonstrating changes in
the intervertebral disks, the spinal cord, the nerve roots, and the surrounding
soft tissue and is currently regarded as the gold standard medical imaging
technique for patients with cervical radicular pain (Van Zundert, Huntoon et
al. 2010). However, these MRI findings are common in both asymptomatic and
symptomatic patients and often fail to correspond to the site of the patient*s
pain. Physiologic imaging with fat-suppressed T2-weighted and/or CE T1-weighted
MR imaging, radionuclide bone scanning, or FDG-PET combined with CT scanning
and functional imaging with weight-bearing or axial loading may demonstrate
findings more specific to the subset of degenerative age-related changes that
are actually responsible for the patient*s pain (Kotsenas 2012)
Study objective
In the literature the effectiveness of the anterior cervical discectomy is
measured using subjective validated questionnaires.It would be an important
improvement if it is possible to detect the inflammatory process of the dorsal
root ganglion with FDG PET/CT. It may give a sharper assessment and a better
evaluation of theanterior cervical discectomy . It also may demonstrate
findings more specific to the subset of degenerative age-related changes that
are actually responsible for the patient*s pain. There are no reports on the
detection of affected sites in cervical radiculair pain with FDG-PET/CT. The
aim of this pilot study is to study the inflammatory response of the affected
dorsal root ganglion in patients with cervical radicular pain due to a
contained soft disc herniation before and three months after a anterior
cervical discectomy and to detect degenerative changes of the cervical spine
three months after the nucleoplasty with FDG PET/CT combined with MRI.
Study design
A pilot study.
Study burden and risks
In this study patients will be exposed two times (T0 and T1) to radioactive
radiation because of the FDG PET- CT. This relative risk is justified against
the expected improved detection of the inflammatory process of the dorsal root
ganglion with an objective diagnostic instrument as FDG PET-CT scanning. It may
give a sharper assessment and a better evaluation of the anterior cervical
discectomy . It may also demonstrate findings more specific to the subset of
degenerative age-related changes that are actually responsible for the
patient*s pain. Participation in this study means an extra time effort to fill
out a number of online questionnaires, and undergo the following tests:
Quantative Sensory Testing, muscular tests at two regular clinic visits (T0 and
T1), and a MRI at T1. For the FDG PET-CT scanning patients will receive an
infusion local, which can cause some pain and patients must be able to lie
still in the PET camera for * hours.
's Gravendijkwal 230
Rotterdam 3000 CA
NL
's Gravendijkwal 230
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
Radicular pain of the lowar cervical spine (C4-7) with an indication for anterior cervical discectomy
Exclusion criteria
Age below 18 and above 65 years; Pregnancy; Lack of cooperation of the patient; Patients who are not able to complete the questionnaires, according to the referring doctor; allergy to contrast dye; diabetics.
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 |
---|---|
CCMO | NL44028.078.13 |