A. What are possible causes of MP and what patients variable are asssociated with MP. What is the natural course and prognosis of MP. What is the influence of MP on the quality of life.B. What is the diagnostic value of SSEP en nerve conduction…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic value of SSEP and nerve conduction studies expressed in positive-
and negative predictive value.
Improvement of symptoms (pain, paresthesias, and hyperesthesia) in patients
with MP 12 weeks after injection with corticosteroids. The pain, numbness and
paresthesias are scored using a visual analog scale. Patient are also asked
whether symptoms have improved, if they have no or only minor symptoms that
they considered so much improved that they felt no further treatment is
necessary.
Secondary outcome
Clincal improvement 6 months after treatment. Improvement in quality of life.
Background summary
Meralgia paresthetica (MP) is a relatively common entrapment neuropathy.
Although this disorder has been known for over 100 years many questions remain
as to the cause, prognosis and treatment of MP and what the role of clinical
neurofysiology is.
Study objective
A. What are possible causes of MP and what patients variable are asssociated
with MP. What is the natural course and prognosis of MP. What is the influence
of MP on the quality of life.
B. What is the diagnostic value of SSEP en nerve conduction studies.
C. What is the diagnostic value of high resolution ultrasound studies.
D. Does an injection with corticosteroids relieve the symptoms of MP.
Study design
Multicentre randomized dubbelblind trial. Patients with the diagnosis MP and
case-controls are included in 3 centres. They are requested to fill in a
questionnaire. A SSEP and nerve conduction studies will be performed. To
exclude root disease needle exam will be done. Patients with MP will be given
an injection with corticosteroids or placebo just next to the nerve where is
passes under the inguinal ligament. The effect of the injection wil be
evaluated after 1, 3 and 6 months.
Study burden and risks
A SSEP, nerve conduction studies and needle examination are performed. These
are studies routinely used in the evaluation of MP and do not pose any
additional risks for participants. An injection with corticosteroids can result
in an adverse reaction to the medication, only minor risks are associated with
this procedure.
joulestraat 44
6533DG
Nederland
joulestraat 44
6533DG
Nederland
Listed location countries
Age
Inclusion criteria
Patient with meralgia paresthetica. The diagnosis is made on clinical grounds, which is an abnormal sensation (pain, numbness, paresthesia, hyperesthesia) on the lateral side of the thigh.
Controls
Patients wit a cervical radiculopathy or radiculopathie L4-L5-S1.
Exclusion criteria
Area of abnormal sensation extending beyond 2cm of the medial axis of the thigh or patella, previous operation for MP, diabetes, clinical symptoms and/or signs of a radiculopathy L2-3-4 or polyneuropathy.
Design
Recruitment
Medical products/devices used
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 | EUCTR2006-006381-42-NL |
| CCMO | NL14117.091.06 |