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Comparison of effectiveness of different surgical treatments for meralgia paresthetica


- candidate number17538
- NTR NumberNTR4530
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-apr-2014
- Secondary IDs13-073 METC
- Public TitleComparison of effectiveness of different surgical treatments for meralgia paresthetica
- Scientific TitleEffectiveness of neurolysis versus neurectomy of the lateral femoral cutaneous nerve (LFCN) in the treatment of meralgia paresthetica
- ACRONYMSTOMP
- hypothesisWe hypothesise a difference in outcome on pain relief in favour of the neurectomy group.
- Healt Condition(s) or Problem(s) studiedMeralgia paresthetica, Surgical treatment
- Inclusion criteria Age 18-65 years
Diagnosis of resistant idiopathic meralgia paresthetica, which must include:
o Symptoms of a burning or tingling sensation in the anterolateral part of one or two thighs
o At least 3 months of conservative treatment consisting of weight reduction (in case of overweight), avoiding wear of tight cloths, reducing repetitive motion (for example cycling), pain medication and local injection of corticosteroids
o One or more positive nerve block(s) (local infiltration with lidocaine) and/or abnormal SSEP or delayed conduction time LFCN
Ability and willingness to comply with project requirements
Written informed consent given by the subject
- 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
No 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate1-apr-2017
- Target number of participants90
- InterventionsNeurolysis vs neurectomy
- Primary outcomeGood outcome Likert scale (1/2)
- Secondary outcomeVAS, Bothersomeness index
- Timepoints6, 12, 26, 52 weeks
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Godard Ruiter, de
- CONTACT for SCIENTIFIC QUERIES Godard Ruiter, de
- Sponsor/Initiator Medical Center Haaglanden
- Funding
(Source(s) of Monetary or Material Support)
Medical Center Haaglanden
- Publications
- Brief summaryMeralgia paresthetica (MP) is a tingling, stinging or burning sensation in the anterolateral part of the thigh. It is often accompanied by varying degrees of numbness. Meralgia paresthetica is caused by a mononeuropathy of the lateral femoral cutaneous nerve (LFCN). It is commonly idiopathic, but can also have a traumatic origin, like seat belt and iatrogenic injury [1]. Usually symptoms are mild and resolve spontaneously. However, it may be severe and limit the patient in daily activities. Extension of the hip, as for example while walking or when driving a car, often exacerbates symptoms. Temporary nerve block with local anesthetic near the anterior superior iliac spine (ASIS) may relief the symptoms and is often used to confirm the diagnosis [2]. MP is the most frequent mononeuropathy of the lower limb and probably more common than recognized [3, 4]. It is often misdiagnosed, especially in children/adolescents [5]. The pure sensory symptoms in MP can be helpful in the differential diagnosis with lumbosacral radiculopathy and orthopedic conditions.
Electrophysiology and nerve block can support the diagnosis [6].

The initial treatment of MP is wait and see supported by conservative measures such as avoiding wear of tightly fitting cloths, analgetics and loss of weight by obese patients. It is reported to be successful in pain relief in about 90% of the cases [2]. If conservative treatment fails surgical treatment should be considered. The two main surgical options are neurolysis and neurectomy. In general, success rates are higher for the neurectomy procedure [7], but an obvious disadvantage is loss of sensation in the anterolateral part of the thigh. We recently reported our results for both procedures from two historical cohorts [8]. This study confirmed superior results reported in the literature for the neurectomy procedure (87.5% pain relief versus 60% after the neurolysis procedure). In addition, most patients noted not to be bothered by the numbness following the neurectomy procedure. Shortcomings of this study however are that it was conduced retrospective for two historical cohorts and that patients were not blinded for the procedure. No randomized study has been performed comparing both procedures [7]. Reason for this probably is the small number of patients that require surgery because of persistent symptoms of meralgia paresthetica. Therefore, a randomized trial can only be performed if multiple centres specialized in this type of surgery participate.

In this study protocol we will randomly and blindly compare both surgical procedures (neurolysis versus neurectomy) in patients with persistent symptoms of idiopathic meralgia paresthetica despite conservative treatment. We hypothesise a difference in outcome on pain relief in favour of the neurectomy group. Primary outcome measure will be the 7-point Likert scale (to determine perceived recovery). Secondary outcome measures will include VAS pain and Bothersomeness Index (to determine how much patients are bothered by the numbness following the neurectomy procedure) [9].
- Main changes (audit trail)
- RECORD20-apr-2014 - 21-mei-2014


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