The aim of this study is to analyse the analgetic effect of a local injection in the lateral femoral cutaneous nerve ( LFCN) with methylprednisolone/lidocaine (M/L) after localisation through elektro stimulation VS placebo. In this trial we hope to…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint will be reduction of the pain score on a visual analogue scale
(VAS).
Secondary outcome
Secondary endpoints are:
- Pain reduction after injection measured on a different scale (pain worsening,
no improvement of pain, slight to moderate improvement of pain, complete
remission of pain.)
- Duration of pain reduction
- Reduction of oral analgetics ( descriptive)
Background summary
Meralgia paresthetica (MP) is a mononeuropathy of the lateral femoral cutaneous
nerve (LFCN) characterized by pain, numbness and tingling in the anterolateral
aspect of the thigh. It can be organized as an entrapment neuropathy with a
long list of differential diagnosis. Frequently its cause is spontaneous
which include mechanical factors such as obesity, wearing a tight belt and
other conditions associated with increased intra-abdominal pressure ( 1). The
incidence of meralgia paresthetica in the Rotterdam area is 4.3 per 10.000 a
year. (2). In a previous study five different types of anatomical variation
were described.(3) For interventional treatment of meralgia paresthetica such
as local injections with anesthetics and corticosteroids the evidence is
limited but seems beneficial however it has previously been performed in a
blind fashion using an anatomical landmark. Locating a nerve with
electrostimulation is easily applicable and usually well tolerated by
patients. It does not require a radiologist or neurologist specialized in
ultrasound.(4) This therapy can be used for a more accurate localization and a
more accurate blockade of the LFCN.*
Study objective
The aim of this study is to analyse the analgetic effect of a local injection
in the lateral femoral cutaneous nerve ( LFCN) with
methylprednisolone/lidocaine (M/L) after localisation through elektro
stimulation VS placebo. In this trial we hope to objectify:
Therapeutic value of a localized injection with M/L in MP patients, when
localized by elektro-stimulation.
Study design
This will be a single centered double-blind randomized placebo-controlled
intervention study.
Intervention
Patients will be injected with 2,5 ml methylprednisolone/lidocaine or 2,5 ml
saline 0,9% 1 cm medial of the anterior superior iliac spine after
localisation with electro stimulation of the LFCN.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
Needle examination is a study that is often used for the treatment of MP and
does not form an additional risk for the patient group. Often described adverse
effects for both groups are haematoma, reversible dermatomal change or duration
of pain after injection. Furthermore a temporary increase in numbness in the
area of the LFCN can occur.
Leyweg 275
Den haag 2545CH
NL
Leyweg 275
Den haag 2545CH
NL
Listed location countries
Age
Inclusion criteria
Adult patients with newly diagnosed idiopathic meralgia paresthetica will be recruited. Age: 18 years and older. Duration 4 weeks or more.
Diagnostic criteria: Meralgia paresthetica characterized by pain, numbness and tingling in the anterolateral aspect of the thigh in the area of the LFCN
Exclusion criteria
1. Coexisting disorders or conditions that may mimic MP such as lumbar radiculopathy, severe polyneuropathy.
2. Known allergic reaction to methylprednisolone/lidocaine.
3. Pregnancy
4. No localization possible through electrostimulation
5. Systemic viral or fungal infections
6. Known allergy to steroids
7. No injection with steroids can be given in a vicinity of a preexistent infectious area
Design
Recruitment
Medical products/devices used
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 |
---|---|
EudraCT | EUCTR2014-004052-54-NL |
CCMO | NL50504.098.15 |