The goal of the stomp trial will be to investigate the effectiveness of both the neurolysis and neurectomy procedure in patients with persistent symptoms of meralgia paresthetica. In addition, in this trial we want to determine to what extend…
ID
Source
Brief title
Condition
- Peripheral neuropathies
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Likert scale for self-perceived recovery.
Secondary outcome
VAS, Bothersomeness index for pain and numbness.
Background summary
Despite conservative therapy with pain medication, meralgia paresthetica
persists in about 10% of the patients. These patients are candidates for
surgical therapy. There are two surgical option: neurolysis and neurectomy.
During the neurolysis procedure the nerve is released at the site where it runs
through the inguinal ligament of Poupart. This results in pain relief in about
60% of the cases. During the neurectomy procedure the nerve is transected
proximal to the ligament. The latter procedure results in pain relief in about
90% of the cases, but obviously disadvantage of this procedure is a
postoperative area of numbness in the thigh. We found in a recent retrospective
study that most patients are not bothered by this 1. Disadvantage of this study
however was that it was based on two historical cohorts and that patients were
not blinded for the procedure. Currently, there is no randomized study in the
literature on this subject.
Study objective
The goal of the stomp trial will be to investigate the effectiveness of both
the neurolysis and neurectomy procedure in patients with persistent symptoms of
meralgia paresthetica. In addition, in this trial we want to determine to what
extend patients are bothered by the numbness following the neurectomy
procedure. For the latter we will use the Sciatica Bothersomeness Index.
Study design
Patients with persistent symptoms of meralgia paresthetica (despite at least 3
months of conservative therapy) will be randomized for two surgical treatments.
After the surgery patients will be followed for 1 year.
Intervention
Neurolysis versus neurectomy
Study burden and risks
Besides the standard visits to the outpatient clinic after 6 weeks, patient
will receive a call after 12, 26 and 52 weken. There is no other burden, and
there are no risks for the patient.
Lijnbaan 32
Den Haag 2512VA
NL
Lijnbaan 32
Den Haag 2512VA
NL
Listed location countries
Age
Inclusion criteria
* diagnosis of resistant idiopathic meralgia paresthetica.
* age 18-80 years
* ability and willingness to comply with project requirements
* written informed consent
Exclusion criteria
* Previous surgery for meralgia paresthetica
* Nerve root compression on MRI of the lumbar spine
* Intra-abdominal lesion or previous abdominal surgery, including qynecologic
surgery, surgery for inguinal herniation, hip surgery
* Other previous trauma to the inguinal area, which may have caused symptoms of
meralgia paresthetica, including fe seat-belt injury
* Severe mental or psychiatric disorder
* Inadequate Dutch or English language
* Planned (e)migration abroad in the year after inclusion
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL46074.098.13 |